Randomized controlled trial of the effectiveness of olive and black seed oil combination on pain intensity and episiotomy wound healing in primiparous women: A study protocol

Romina Fili; Fereshteh Behmanesh; Sana Nazmi; Maryam Nikpour; Zahra Memariani

doi:10.1371/journal.pone.0302161

Peer Review History

Original SubmissionNovember 4, 2023
30 Nov 2023 Decision Letter - Eunice Bolanle Turawa, Editor PONE-D-23-34640Randomized controlled trial of the effectiveness of olive and black seed oil combination in pain intensity and episiotomy wound healing in primiparous women: study protocolPLOS ONE Dear Dr. Fereshteh Behmanesh, Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process. Improve the general outlook of the protocol by restructuring sentences, make your statement clear and logical to enable your readers understand your work. Also, attend to incomplete sentences to use of words. Make protocol succinct and avoid repetitions. The "Material and methods" section can be structured to reflect the following: Study design Eligibility criteria Study sample and sampling Data collection and management Data analysis Report Authors can then resubmit the protocol for review. Please submit your revised manuscript by Jan 14 2024 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file. Please include the following items when submitting your revised manuscript: A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'. A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'. An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'. If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter. We look forward to receiving your revised manuscript. Kind regards, Eunice Bolanle Turawa, MSc Academic Editor PLOS ONE Journal Requirements: When submitting your revision, we need you to address these additional requirements. 1. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. The PLOS ONE style templates can be found at https://journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf and https://journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf 2. Thank you for stating in your Funding Statement: "This study was financially supported by Babol University of Medical Sciences. Award Number: 724134467. F.B will receive the fund. URL: https://www.mubabol.ac.ir/ This funder contributed to the approval of the study." Please provide an amended statement that declares all the funding or sources of support (whether external or internal to your organization) received during this study, as detailed online in our guide for authors at http://journals.plos.org/plosone/s/submit-now. Please also include the statement “There was no additional external funding received for this study.” in your updated Funding Statement. Please include your amended Funding Statement within your cover letter. We will change the online submission form on your behalf. 3. Thank you for stating the following in the Acknowledgments Section of your manuscript: "The authors would like to thank the Deputy of Research and Technology of Babol University of Medical Sciences for supporting the project." We note that you have provided funding information that is not currently declared in your Funding Statement. However, funding information should not appear in the Acknowledgments section or other areas of your manuscript. We will only publish funding information present in the Funding Statement section of the online submission form. Please remove any funding-related text from the manuscript and let us know how you would like to update your Funding Statement. Currently, your Funding Statement reads as follows: "This study was financially supported by Babol University of Medical Sciences. Award Number: 724134467. F.B will receive the fund. URL: https://www.mubabol.ac.ir/ This funder contributed to the approval of the study." Please include your amended statements within your cover letter; we will change the online submission form on your behalf. 4. We note that you have stated that you will provide repository information for your data at acceptance. Should your manuscript be accepted for publication, we will hold it until you provide the relevant accession numbers or DOIs necessary to access your data. If you wish to make changes to your Data Availability statement, please describe these changes in your cover letter and we will update your Data Availability statement to reflect the information you provide. 5. Please note that in order to use the direct billing option the corresponding author must be affiliated with the chosen institute. Please either amend your manuscript to change the affiliation or corresponding author, or email us at plosone@plos.org with a request to remove this option. 6. Your ethics statement should only appear in the Methods section of your manuscript. If your ethics statement is written in any section besides the Methods, please delete it from any other section. 7. We note that the original protocol that you have uploaded as a Supporting Information file contains an institutional logo. As this logo is likely copyrighted, we ask that you please remove it from this file and upload an updated version upon resubmission. 8. Please include captions for your Supporting Information files at the end of your manuscript, and update any in-text citations to match accordingly. Please see our Supporting Information guidelines for more information: http://journals.plos.org/plosone/s/supporting-information. Additional Editor Comments: Study protocol." This is a clinical trial involving first-time mothers in early postpartum period. The protocol requires general restructuring for clarity, ease communication flow, and scientific soundness. Incomplete and unclear sentences should be improved on. Also, make the protocol succinct without repetitions. Attachments Attachment Submitted filename: PONE-D-23-34640 et 22Nov 2023 .pdf https://doi.org/10.1371/journal.pone.0302161.r001
Revision 1
7 Dec 2023 Author Response Dear editor PLOS ONE Thank you and the honorable Reviewer (s) for your valuable comments for the manuscript entitled: Randomized controlled trial of the effectiveness of olive and black seed oil combination on pain intensity and episiotomy wound healing in primiparous women: study protocol (PONE-D-23-34640). These comments are very useful in the scientific improvement of the manuscript. Responses to the following comments are given: 1. Improve the general outlook of the protocol by restructuring sentences, make your statement clear and logical to enable your readers understand your work. Also, attend to incomplete sentences to use of words. Regards, corrected. 2. Make protocol succinct and avoid repetitions. These items have been corrected and marked in the text with track changes. 3. The "Material and methods" section can be structured to reflect the following: Study design Eligibility criteria Study sample and sampling Data collection and management Data analysis Report Sincerely, corrected. 4. Please include the following items when submitting your revised manuscript: A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'. Done A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'. Done An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'. Done If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Corrected. Journal Requirements: When submitting your revision, we need you to address these additional requirements. 1. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. The PLOS ONE style templates can be found at https://journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf and https://journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf This manuscript meets PLOS ONE's style requirements, including those for file naming. 2. Thank you for stating in your Funding Statement: "This study was financially supported by Babol University of Medical Sciences. Award Number: 724134467. F.B will receive the fund. URL: https://www.mubabol.ac.ir/ This funder contributed to the approval of the study." Please provide an amended statement that declares all the funding or sources of support (whether external or internal to your organization) received during this study, as detailed online in our guide for authors at http://journals.plos.org/plosone/s/submit-now. Please also include the statement “There was no additional external funding received for this study.” in your updated Funding Statement. Please include your amended Funding Statement within your cover letter. We will change the online submission form on your behalf. Corrected 3. Thank you for stating the following in the Acknowledgments Section of your manuscript: "The authors would like to thank the Deputy of Research and Technology of Babol University of Medical Sciences for supporting the project." We note that you have provided funding information that is not currently declared in your Funding Statement. However, funding information should not appear in the Acknowledgments section or other areas of your manuscript. We will only publish funding information present in the Funding Statement section of the online submission form. Please remove any funding-related text from the manuscript and let us know how you would like to update your Funding Statement. Currently, your Funding Statement reads as follows: "This study was financially supported by Babol University of Medical Sciences. Award Number: 724134467. F.B will receive the fund. URL: https://www.mubabol.ac.ir/ This funder contributed to the approval of the study." The Acknowledgments Section corrected: The authors would like to thank the Deputy of Research and Technology of Babol University of Medical Sciences and mothers who will participate in this study. Please include your amended statements within your cover letter; we will change the online submission form on your behalf. The amended statements was included in the cover letter. 4. We note that you have stated that you will provide repository information for your data at acceptance. Should your manuscript be accepted for publication, we will hold it until you provide the relevant accession numbers or DOIs necessary to access your data. If you wish to make changes to your Data Availability statement, please describe these changes in your cover letter and we will update your Data Availability statement to reflect the information you provide. This is a protocol study and data availability are not applicable. This sentence is included in the manuscript and cover letter. 5. Please note that in order to use the direct billing option the corresponding author must be affiliated with the chosen institute. Please either amend your manuscript to change the affiliation or corresponding author, or email us at plosone@plos.org with a request to remove this option. I emailed to plosone@plos.org with a request to remove the direct billing option. 6. Your ethics statement should only appear in the Methods section of your manuscript. If your ethics statement is written in any section besides the Methods, please delete it from any other section. Corrected. It deleted from declarations. 7. We note that the original protocol that you have uploaded as a Supporting Information file contains an institutional logo. As this logo is likely copyrighted, we ask that you please remove it from this file and upload an updated version upon resubmission. I removed it from the original protocol and uploaded an updated version upon resubmission. 8. Please include captions for your Supporting Information files at the end of your manuscript, and update any in-text citations to match accordingly. Please see our Supporting Information guidelines for more information: http://journals.plos.org/plosone/s/supporting-information. Corrected based on Supporting Information guidelines. Attachments Attachment Submitted filename: Response to reviewers.docx https://doi.org/10.1371/journal.pone.0302161.r002
4 Jan 2024 Decision Letter - Eunice Bolanle Turawa, Editor PONE-D-23-34640R1. Randomized controlled trial of the effectiveness of olive and black seed oil combination on pain intensity and episiotomy wound healing in primiparous women: Study protocol. Dear Dr. Behmanesh, Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process. Be sure the entire manuscript undergoes thorough editing, focusing on grammar, spelling, and typo errors. It is advisable you use English expert services. We anticipate your revised manuscript and appreciate your attention to these details. Please submit your revised manuscript by Feb 18 2024 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file. Please include the following items when submitting your revised manuscript: A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'. A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'. An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'. If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter. If applicable, we recommend that you deposit your laboratory protocols in protocols.io to enhance the reproducibility of your results. Protocols.io assigns your protocol its own identifier (DOI) so that it can be cited independently in the future. For instructions see: https://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols. Additionally, PLOS ONE offers an option for publishing peer-reviewed Lab Protocol articles, which describe protocols hosted on protocols.io. Read more information on sharing protocols at https://plos.org/protocols?utm_medium=editorial-email&utm_source=authorletters&utm_campaign=protocols. We look forward to receiving your revised manuscript. Kind regards, Eunice Bolanle Turawa, MSc Academic Editor PLOS ONE Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. Does the manuscript provide a valid rationale for the proposed study, with clearly identified and justified research questions? The research question outlined is expected to address a valid academic problem or topic and contribute to the base of knowledge in the field. Reviewer #1: Yes Reviewer #2: No Reviewer #3: Yes ******** 2. Is the protocol technically sound and planned in a manner that will lead to a meaningful outcome and allow testing the stated hypotheses? The manuscript should describe the methods in sufficient detail to prevent undisclosed flexibility in the experimental procedure or analysis pipeline, including sufficient outcome-neutral conditions (e.g. necessary controls, absence of floor or ceiling effects) to test the proposed hypotheses and a statistical power analysis where applicable. As there may be aspects of the methodology and analysis which can only be refined once the work is undertaken, authors should outline potential assumptions and explicitly describe what aspects of the proposed analyses, if any, are exploratory. Reviewer #1: Yes Reviewer #2: Yes Reviewer #3: Yes ****** 3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable? Descriptions of methods and materials in the protocol should be reported in sufficient detail for another researcher to reproduce all experiments and analyses. The protocol should describe the appropriate controls, sample size calculations, and replication needed to ensure that the data are robust and reproducible. Reviewer #1: Yes Reviewer #2: No Reviewer #3: Yes ****** 4. Have the authors described where all data underlying the findings will be made available when the study is complete? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception, at the time of publication. The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified. Reviewer #1: Yes Reviewer #2: No Reviewer #3: No ****** 5. Is the manuscript presented in an intelligible fashion and written in standard English? PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here. Reviewer #1: No Reviewer #2: No Reviewer #3: Yes ****** 6. Review Comments to the Author Please use the space provided to explain your answers to the questions above and, if applicable, provide comments about issues authors must address before this protocol can be accepted for publication. You may also include additional comments for the author, including concerns about research or publication ethics. You may also provide optional suggestions and comments to authors that they might find helpful in planning their study. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: Dear Author The manuscript has valuable results but needs essential edition as below: 1- English writing is poor. There are a lot of spelling and grammar errors and editing by a native speaker is necessary. 2- In the introduction: • The mention that not performing an episiotomy leads to severe tearing is not true in all mothers and depends on the case. • In reference number 6, the sentence is incomplete. • Start sentence with “such as” is unusual. 3- In the methods section: • First, the type of study and then the work method should come. • Objectives should be removed from the beginning of the methods section. • In reliability and validity of Reeda tool, please wright the number of reliability and validity. • In inclusion criteria: the sentence is incomplete. 4- Discussion: • Discussion need to an essential revision. • According to the results, conclusion need revision. References: • Some references should be changed basis on guideline format. • Revise the reference list according to Paper Submission Guide: Abstract the name of journals. • More references should be covering the last 5 years. Be succesful Reviewer #2: Thank you as you invited me to review this manuscript. Please see my comments as follows: First of all this study has some grammatical and typo errors and should be revised by an expert person in English literature. Abstract: 1. Method: While one group will receive olive oil plus black seed and one group will receive olive oil alone, why the third group do not receive placebo, and they will receive routine care? Introduction 1. The second point of "highlight" should be revised, as the main reason for using herbs is their safety and not the high costs of pharmaceutical treatment. 2. Authors stated that if not using the episiotomy, there is a perineal tears that may cause problem for mother. Non-indicated episiotomy causes many problems for mother such as sexual dysfunction and pain. Please mention the rate of episiotomy especially non-indicated in Iran. 3. Please be careful and exact when you are talking about side effects of medications. After delivery, women just receive an analgesic for reducing their pain and analgesics are not expensive and also do not have many side effects. 4. Please use the results of those studies that used olive oil for reducing pain intensity after episiotomy in the introduction. Methods 1. Women who do not use the oil regularly is not exclusion criteria, but they should consider drop-out. 2. Please move the objectives of the study to the end of introduction. 3. Some of exclusion criteria are drop-out that happen during study such as "women who do not use olive oil regularly" 4. Authors stated that they excluded fourth degree tears. Is that mean you will recruit second and third degree tears? 5. Please provide more details about intervention, e.g. what should participants do before applying the oil on the perineum, any washing? 6. Please write how much oil will be given to each participant? 7. The midwife or a gynecologist that perform episiotomy and type of repair are important factors that did not mention by authors in this study. 8. Authors should advise participants to take the similar pain killers. 9. A significance level of 0.05 will be considered in all tests. It should be <0.05. Reviewer #3: This is an interesting study looking at the effect of olive oil and black seed on improving on pain intensity and episiotomy wound healing in primiparous women. This is an inferiority study. Some comments where the details reported could be clarified further. 1. As this a non-inferiority study, the sample size is missing some fundamental information, i.e what was defined as the clinical minimal difference that would constitute non-inferior. Type 1 error information should be included in sample size calculation. In addition as this is a 3 arms trial, is the non-inferiority hypothesis in relation to control vs EACH intervention, make this comparison explicit and define this. 2. For the randomisation process, please indicate the allocation ratio. No need to state the "The size of the blocks is 6, and 18 blocks of 6 are produced to create a sequence of size 108". You could just state, variable block size. And perharps include this here " (One group, olive oil plus black seed oil and another group of olive oil alone) and control group is routine care" 3. Unsure what this sentence means "The supervisor, researcher and statistical analyst will be blinded to perform proper management." Do you mean blinded analysis? 4. Define primary outcome, i.e pain intensity- how is this measured? How will healing be measured? 5. Same comment for Secondary outcomes, how will these be defined? 6. Define what you mean by intention to treat analysis, i,e people analysed according to the group there were assigned regardless of taking allocated intervention. 7. More information in the analysis section, i.e mention that data will be reported to CONSORT guidelines as this an RCT. 8. In the analysis section as this an RCT, no need to carry out formal tests on baseline characteristics as this not recommended, since any differences would occur by chance. Also mention that all details regarding analysis will be stated in the statistical analysis plan. 9. What is justification of using multi-level modelling? I.e what are the repeated measures of random effect variable? 10. How will adherence/compliance be assessed? ****** 7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files. If you choose “no”, your identity will remain anonymous but your review may still be made public. Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy. Reviewer #1: No Reviewer #2: Yes: Parvin Abedi Reviewer #3: No ******** [NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.] While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step. https://doi.org/10.1371/journal.pone.0302161.r003
Revision 2
15 Jan 2024 Author Response Dear Editor in Chief PONE-ONE Thank you for your thorough review and consideration of our manuscript “Randomized controlled trial of the effectiveness of olive and black seed oil combination on pain intensity and episiotomy wound healing in primiparous women: Study protocol" (PONE-D-23-34640R1) that was submitted to the PONE-ONE. We believe that the comments and suggestions that were recommended by the reviewers have informed a much improved and more fully developed paper that will offer an important contribution to the field. We have highlighted the changes that were undertaken in response to your comments in the revised manuscript. Responses to each of your comments are below. Thanks for your kind attention to the manuscript. Sincerely, Corresponding author Dr Fereshteh Behmanesh Reproductive Health Reviewers Response Reviewer 1 The manuscript has valuable results but needs essential edition as below: 1- English writing is poor. There are a lot of spelling and grammar errors and editing by a native speaker is necessary. Thank you very much for the opinion of the respected reviewer, according to the suggestion of dear reviewer, this manuscript will be edited by a native and the certificate will be sent for Journal. 2- In the introduction: • The mention that not performing an episiotomy leads to severe tearing is not true in all mothers and depends on the case. Corrected, p 3, par 1 In reference number 6, the sentence is incomplete. Corrected, p 3, par 2 Start sentence with “such as” is unusual. Corrected, p 4, line 1 & p10, par 3 In the methods section: • First, the type of study and then the work method should come. First, the type of study and then the work method writhed. P 5, par 2 Objectives should be removed from the beginning of the methods section. Removed and the third objective added in the end of introduction. P 5, par 1 • In reliability and validity of Reeda tool, please wright the number of reliability and validity. Corrected. P 8 & 9 In inclusion criteria: the sentence is incomplete. Corrected. P6, par 2 Discussion: • Discussion needs to an essential revision. In the protocol study, considering that the findings are not clear, the discussion cannot be written in detail. However, it was corrected according to the comment of the respected referee. According to the results, conclusion need revision. Corrected. P11, par 2 References: • Some references should be changed basis on guideline format. • Revise the reference list according to Paper Submission Guide: Abstract the name of journals. • More references should be covering the last 5 years. Corrected based on guideline format. Reviewer 2 First of all this study has some grammatical and typo errors and should be revised by an expert person in English literature. Thank you very much for the opinion of the respected reviewer, according to the suggestion of dear reviewer, this manuscript will be edited by a native and the certificate will be sent for Journal. Abstract: 1. Method: While one group will receive olive oil plus black seed and one group will receive olive oil alone, why the third group do not receive placebo, and they will receive routine care? This is a very good question. By the way, the research team had also thought about this issue. But since the use of any oil may have a positive or negative effect on wound healing, for this reason placebo was not used in the control group. Introduction 1. The second point of "highlight" should be revised, as the main reason for using herbs is their safety and not the high costs of pharmaceutical treatment. With respect to the reviewer’s comment, corrected. P 3 2. Authors stated that if not using the episiotomy, there is a perineal tears that may cause problem for mother. Non-indicated episiotomy causes many problems for mother such as sexual dysfunction and pain. Please mention the rate of episiotomy especially non-indicated in Iran. With respect to the reviewer's comment, unfortunately, the incidence of non-indicated episiotomy in Iran was not found in our search. Perhaps because if an episiotomy is non-indicated, the doctor or midwife will not report it due to legal claims. The following sentence was used instead: In Iran, episiotomy is still common and its prevalence is reported in more than 41% of primiparous women. 3. Please be careful and exact when you are talking about side effects of medications. After delivery, women just receive an analgesic for reducing their pain and analgesics are not expensive and also do not have many side effects. Thanks to the reviewer, this sentence was removed. Of course, in Iran, in addition to painkillers, most doctors routinely prescribe antibiotics after delivery with episiotomy. 4. Please use the results of those studies that used olive oil for reducing pain intensity after episiotomy in the introduction. Added. P4, par 2 Methods 1. Women who do not use the oil regularly is not exclusion criteria, but they should consider drop-out. While thanking the respected reviewer, since our analysis method is ITT, the women should consider drop-out based on reviewer comment. This exclusion criteria were written incorrectly in the manuscript and has now been removed. P 6 2. Please move the objectives of the study to the end of introduction. Removed and the third objective added in the end of introduction. P 5, par 1 3. Some of exclusion criteria are drop-out that happen during study such as "women who do not use olive oil regularly" While thanking the respected reviewer, since our analysis method is ITT, the women should consider drop-out based on reviewer comment. This exclusion criteria were written incorrectly in the manuscript and has now been removed. P 6 4. Authors stated that they excluded fourth degree tears. Is that mean you will recruit second and third degree tears? Yes, that is right. We will recruit second- and third-degree tears. 5. Please provide more details about intervention, e.g. what should participants do before applying the oil on the perineum, any washing? Provided. The samples were asked to wash and dry their perineum before using oils. Then wear gloves and slowly pour 10 drops of oil on the perineum and massage with hands. P 8, par 1 6. Please write how much oil will be given to each participant? Considering that each cc contains 15 drops and mothers should use oils three times a day, approximately 30 cc of each type of oil was given to mothers for 10 days. P 8, par 1 7. The midwife or a gynecologist that perform episiotomy and type of repair are important factors that did not mention by authors in this study. The type of repair will be evaluated by questionnaire but the midwife or a gynecologist that perform episiotomy will not be checked. However, in the author's previous study, this issue was investigated and had no effect on the results of the study. 8. Authors should advise participants to take the similar pain killers The type of painkiller and its number per day in three groups is evaluated by a checklist that is completed by the mother within ten days and then evaluated and considered as auxiliary variable in the final analysis. 9. A significance level of 0.05 will be considered in all tests. It should be <0.05. corrected Reviewer 3 This is an interesting study looking at the effect of olive oil and black seed on improving on pain intensity and episiotomy wound healing in primiparous women. Some comments where the details reported could be clarified further. 1. As this a non-inferiority study, the sample size is missing some fundamental information, i.e what was defined as the clinical minimal difference that would constitute non-inferior. Type 1 error information should be included in sample size calculation. In addition as this is a 3 arms trial, is the non-inferiority hypothesis in relation to control vs EACH intervention, make this comparison explicit and define this. Thank you very much for the comments of the respected reviewer According to the suggestion of dear reviewer. Sample size corrected 2. For the randomisation process, please indicate the allocation ratio. No need to state the "The size of the blocks is 6, and 18 blocks of 6 are produced to create a sequence of size 108". You could just state, variable block size. And perharps include this here " (One group, olive oil plus black seed oil and another group of olive oil alone) and control group is routine care" According to the suggestion of dear reviewer, corrected 3. Unsure what this sentence means "The supervisor, researcher and statistical analyst will be blinded to perform proper management." Do you mean blinded analysis? As in this sentence: the statistical analyst does not know about the study groups and it will be determined after the statistical analysis (only the pharmacist knows) 4. Define primary outcome, i.e pain intensity- how is this measured? How will healing be measured? The measurement of pain intensity and wound healing is written in detail in the subtitle of "data collection and management" of the method section in paragraphs 5 and 6. According to the suggestion of dear reviewer, definition of pain intensity and wound healing was added. The intensity of perineal pain is the pain that mothers feel in their perineal area and it is recorded by self-report method before and after the intervention. Skin wound healing is an essential physiological process that consists of the cooperation of many cell strains and their products. Attempts to repair the lesion caused by local invasion begin very early in the inflammatory phase. Finally, they lead to repair, which involves the replacement of specialized structures caused by collagen deposition and regeneration, which is related to the process of cell proliferation and posterior differentiation through cells already present in tissue cells. 5. Same comment for Secondary outcomes, how will these be defined? The primary outcomes are pain intensity in the episiotomy area and healing of episiotomy wound. The secondary outcomes are Burning and itching and episiotomy opening and the need for painkillers which will be evaluated through examination by the researcher and through mother's self-report. 6. Define what you mean by intention to treat analysis, i,e people analysed according to the group there were assigned regardless of taking allocated intervention. We will use intention-to-treat analysis in this study, because intention-to-treat analysis will provide an unbiased estimate of the efficacy of the intervention at the level of adherence in the study. 7. More information in the analysis section, i.e mention that data will be reported to CONSORT guidelines as this an RCT. Statistical analysis according to CONSORT guidelines was written. 8. In the analysis section as this an RCT, no need to carry out formal tests on baseline characteristics as this not recommended, since any differences would occur by chance. Also mention that all details regarding analysis will be stated in the statistical analysis plan. According to the suggestion of dear reviewer, this sentence was removed 9. What is justification of using multi-level modelling? I.e what are the repeated measures of random effect variable? Multilevel linear regression will be done for adjust confounders variables (demographic, midwifery and delivery). In the section of statistical analysis was added and repeat measurement analysis was removed. 10. How will adherence/compliance be assessed? Multilevel linear regression will be done for adjust confounders variables (demographic, midwifery and delivery). • A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'. • An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'. Attachments Attachment Submitted filename: Response to Reviewers 25-10-402.docx https://doi.org/10.1371/journal.pone.0302161.r004
23 Feb 2024 Decision Letter - Ahmed Mohamed Maged, Editor PONE-D-23-34640R2Randomized Controlled Trial of the Effectiveness of Olive and Black Seed Oil Combination on Pain Intensity and Episiotomy Wound Healing in Primiparous Women: A Study ProtocolPLOS ONE Dear Dr. Behmanesh, Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process. ============================== ACADEMIC EDITOR: Please respond to all reviewers comments ============================== Please submit your revised manuscript by Apr 08 2024 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file. Please include the following items when submitting your revised manuscript: A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'. A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'. An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'. If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter. If applicable, we recommend that you deposit your laboratory protocols in protocols.io to enhance the reproducibility of your results. Protocols.io assigns your protocol its own identifier (DOI) so that it can be cited independently in the future. For instructions see: https://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols. Additionally, PLOS ONE offers an option for publishing peer-reviewed Lab Protocol articles, which describe protocols hosted on protocols.io. Read more information on sharing protocols at https://plos.org/protocols?utm_medium=editorial-email&utm_source=authorletters&utm_campaign=protocols. We look forward to receiving your revised manuscript. Kind regards, Ahmed Mohamed Maged, MD Academic Editor PLOS ONE [Note: HTML markup is below. Please do not edit.] Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. Does the manuscript provide a valid rationale for the proposed study, with clearly identified and justified research questions? The research question outlined is expected to address a valid academic problem or topic and contribute to the base of knowledge in the field. Reviewer #3: Yes Reviewer #4: Yes Reviewer #5: Yes ******** 2. Is the protocol technically sound and planned in a manner that will lead to a meaningful outcome and allow testing the stated hypotheses? The manuscript should describe the methods in sufficient detail to prevent undisclosed flexibility in the experimental procedure or analysis pipeline, including sufficient outcome-neutral conditions (e.g. necessary controls, absence of floor or ceiling effects) to test the proposed hypotheses and a statistical power analysis where applicable. As there may be aspects of the methodology and analysis which can only be refined once the work is undertaken, authors should outline potential assumptions and explicitly describe what aspects of the proposed analyses, if any, are exploratory. Reviewer #3: Yes Reviewer #4: Partly Reviewer #5: Yes ****** 3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable? Descriptions of methods and materials in the protocol should be reported in sufficient detail for another researcher to reproduce all experiments and analyses. The protocol should describe the appropriate controls, sample size calculations, and replication needed to ensure that the data are robust and reproducible. Reviewer #3: Yes Reviewer #4: No Reviewer #5: Yes ****** 4. Have the authors described where all data underlying the findings will be made available when the study is complete? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception, at the time of publication. The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified. Reviewer #3: Yes Reviewer #4: No Reviewer #5: Yes ****** 5. Is the manuscript presented in an intelligible fashion and written in standard English? PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here. Reviewer #3: Yes Reviewer #4: Yes Reviewer #5: Yes ****** 6. Review Comments to the Author Please use the space provided to explain your answers to the questions above and, if applicable, provide comments about issues authors must address before this protocol can be accepted for publication. You may also include additional comments for the author, including concerns about research or publication ethics. You may also provide optional suggestions and comments to authors that they might find helpful in planning their study. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #3: All comments have been addressed. Reviewer #4: Dears • Report rate of episiotomy in Iran? • In the introduction: Explain setting of the study and how used type of oil therapy people (primiparous) based on culture. • There are many confounding variables which must be controlled. In Iranian hospitals, the most childbirth is performed by gynecological assistants or midwifery students, with many interventions; confounding variables: for example, time and type of Epi repair, the number of cutgut chromic sutures, Length and depth of episiotomy. fetal information: fetal weight, fetus position of the occiput posterior or anterior, labor information: duration of the first and second stage, removal of the placenta by hand and etc. • Isn’t report the type of random allocation process. • How will adherence/compliance be assessed? • How many times a day were used the oils? • Was it used based on individual demand and then will be recorded. • Isn’t report Reliability this research. • From the ethical point of view, all three groups should have received painkiller, it should be reported which group used less. • Report of side effect essential oils? • when Intensity pain and wound healing will be measured? • How Intensity pain and wound healing will be measured? in REEDA scale for evaluate items; sterile tapes should be used to mark the amount of bruising and redness and... then measure with a ruler. • Limitation? For example, this primiparous they change our location during first days, Especially the tenth day, from the mother's house to her house and they are not present at the previous address. Sincerely Reviewer #5: Thank you very much for giving me the opportunity to review this manuscript. I congratulate the authors for the work done. I don't have comment. ****** 7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files. If you choose “no”, your identity will remain anonymous but your review may still be made public. Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy. Reviewer #3: No Reviewer #4: No Reviewer #5: No ******** [NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.] While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step. https://doi.org/10.1371/journal.pone.0302161.r005
Revision 3
6 Mar 2024 Author Response Dear Editor PONE-ONE Thank you for your thorough review and consideration of our manuscript “Randomized controlled trial of the effectiveness of olive and black seed oil combination on pain intensity and episiotomy wound healing in primiparous women: Study protocol" (PONE-D-23-34640R1) that was submitted to the PONE-ONE. We believe that the comments and suggestions that were recommended by the reviewers have informed a much improved and more fully developed paper that will offer an important contribution to the field. We have highlighted the changes that were undertaken in response to your comments in the revised manuscript. Responses to each of your comments are below: Thanks for your kind attention to the manuscript. Sincerely, Corresponding author Dr Fereshteh Behmanesh Reproductive Health Reviewers Response Reviewer #3: All comments have been addressed. Thank you very much for your valuable comments in the previous review. Reviewer #4 1-Report rate of episiotomy in Iran? Thank you very much for the attention of the honorable reviewer, rate of episiotomy in Iran added to the introduction. (P4, Par 2) 2- In the introduction: Explain setting of the study and how used type of oil therapy people (primiparous) based on culture. Corrected (P 6) There are many confounding variables which must be controlled. In Iranian hospitals, the most childbirth is performed by gynecological assistants or midwifery students, with many interventions; confounding variables: for example, time and type of Epi repair, the number of cutgut chromic sutures, Length and depth of episiotomy. fetal information: fetal weight, fetus position of the occiput posterior or anterior, labor information: duration of the first and second stage, removal of the placenta by hand and etc. You are absolutely right. But as you know, not all interfering factors can be controlled in studies. One of the ways to reduce the effect of these interfering factors is random sampling, which will be considered in this study. However, many of these factors are investigated by the research team. Isn’t report the type of random allocation process. Thanks to the accuracy of the reviewer, it was corrected (P8, Par 3). How will adherence/compliance be assessed? In this study, we will examine the adherence of the samples to drug use and side effects. As mentioned in the method, the use of medicine, painkillers and complications of the intervention will be recorded by the mothers within ten days by means of a designed checklist. Also, during two to three phone calls, in these ten days, they are emphasized about the use of oils. (p11, par 2) How many times a day were used the oils? Oils will be used 3 times a day (p9, par 2) Was it used based on individual demand and then will be recorded. After explaining the objectives of the research, any mother who is willing to participate in the study and meets the inclusion criteria will be included. The number of mothers who don’t like to participate in this study, will be recorded.(p9, par 1) Isn’t report Reliability this research. Reliability of this research added to the method. To ensure the reliability of this research, the person who examines the episiotomy wound on the first and tenth days will be the same for all mothers.(p 8, par 4) From the ethical point of view, all three groups should have received painkiller, it should be reported which group used less. Thank you very much for your accuracy, you are absolutely right. This was written in the manuscript. All three groups can use painkillers. Also, people report how many painkillers they used in ten days by self-reporting through a checklist provided to them. This is mentioned in the method. (p 9, par 3) Report of side effect essential oils? The side effects of essential oils will be assessed and reported. This is mentioned in the method. (p 11, par 2) when Intensity pain and wound healing will be measured? In the first 24 hours after delivery, and ten days later. This corrected in the method. (p9, the last paragragh) How Intensity pain and wound healing will be measured? in REEDA scale for evaluate items; sterile tapes should be used to mark the amount of bruising and redness and... then measure with a ruler. Pain intensity will be measured by VAS based on mother’s self-reporting. About REEDA scale, You are right. But because of the limitations of using sterile tapes in our research, we will use visual inspection. Limitation? For example, this primiparous they change our location during first days, Especially the tenth day, from the mother's house to her house and they are not present at the previous address. On the 10th day, mothers will be gone to the women's clinic of the hospital for examination. (On the 10th day, gynecologists routinely examine mothers' sutures. Therefore, the address of the mother is not important for us. But one of the major limitations of the current study is that some mothers may not return on the 10th day due to the recovery or because of hospitalization of the baby. This restriction was added to the end of the discussion. Reviewer #5: Thank you very much for giving me the opportunity to review this manuscript. I congratulate the authors for the work done. I don't have comment. Thank you very much for your valuable comment. • A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'. • An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'. fereshteh-834 21Aban139322 Attachments Attachment Submitted filename: Response to Reviewers2.docx https://doi.org/10.1371/journal.pone.0302161.r006
22 Mar 2024 Decision Letter - Ahmed Mohamed Maged, Editor PONE-D-23-34640R3Randomized Controlled Trial of the Effectiveness of Olive and Black Seed Oil Combination on Pain Intensity and Episiotomy Wound Healing in Primiparous Women: A Study ProtocolPLOS ONE Dear Dr. Behmanesh, Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process. Please submit your revised manuscript by May 06 2024 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file. Please include the following items when submitting your revised manuscript: A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'. A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'. An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'. If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter. If applicable, we recommend that you deposit your laboratory protocols in protocols.io to enhance the reproducibility of your results. Protocols.io assigns your protocol its own identifier (DOI) so that it can be cited independently in the future. For instructions see: https://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols. Additionally, PLOS ONE offers an option for publishing peer-reviewed Lab Protocol articles, which describe protocols hosted on protocols.io. Read more information on sharing protocols at https://plos.org/protocols?utm_medium=editorial-email&utm_source=authorletters&utm_campaign=protocols. We look forward to receiving your revised manuscript. Kind regards, Ahmed Mohamed Maged, MD Academic Editor PLOS ONE Journal Requirements: Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice. Additional Editor Comments: ============================== ACADEMIC EDITOR: Please respond to all reviewers comments ============================== [Note: HTML markup is below. Please do not edit.] Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. Does the manuscript provide a valid rationale for the proposed study, with clearly identified and justified research questions? The research question outlined is expected to address a valid academic problem or topic and contribute to the base of knowledge in the field. Reviewer #4: Yes ******** 2. Is the protocol technically sound and planned in a manner that will lead to a meaningful outcome and allow testing the stated hypotheses? The manuscript should describe the methods in sufficient detail to prevent undisclosed flexibility in the experimental procedure or analysis pipeline, including sufficient outcome-neutral conditions (e.g. necessary controls, absence of floor or ceiling effects) to test the proposed hypotheses and a statistical power analysis where applicable. As there may be aspects of the methodology and analysis which can only be refined once the work is undertaken, authors should outline potential assumptions and explicitly describe what aspects of the proposed analyses, if any, are exploratory. Reviewer #4: Yes ****** 3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable? Descriptions of methods and materials in the protocol should be reported in sufficient detail for another researcher to reproduce all experiments and analyses. The protocol should describe the appropriate controls, sample size calculations, and replication needed to ensure that the data are robust and reproducible. Reviewer #4: Yes ****** 4. Have the authors described where all data underlying the findings will be made available when the study is complete? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception, at the time of publication. The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified. Reviewer #4: Yes ****** 5. Is the manuscript presented in an intelligible fashion and written in standard English? PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here. Reviewer #4: Yes ****** 6. Review Comments to the Author Please use the space provided to explain your answers to the questions above and, if applicable, provide comments about issues authors must address before this protocol can be accepted for publication. You may also include additional comments for the author, including concerns about research or publication ethics. You may also provide optional suggestions and comments to authors that they might find helpful in planning their study. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #4: Dear authors Thank you for your revises. Please correct these two comments as well: • you record:the number of the painkiller used during 10 days. • you add in the limitations that to assess wound healing, sterile tape was not used and visual inspection was used. Sincerely, Reviewer #4 ****** 7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files. If you choose “no”, your identity will remain anonymous but your review may still be made public. Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy. Reviewer #4: No ******** [NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.] While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step. https://doi.org/10.1371/journal.pone.0302161.r007
Revision 4
26 Mar 2024 Author Response Dear Editor PONE-ONE Thank you for your thorough review and consideration of our manuscript “Randomized controlled trial of the effectiveness of olive and black seed oil combination on pain intensity and episiotomy wound healing in primiparous women: Study protocol" (PONE-D-23-34640R1) that was submitted to the PONE-ONE. Thanks for your kind attention to the manuscript. I review the reference list to ensure that it is complete and correct. Sincerely, Corresponding author Dr Fereshteh Behmanesh PhD in Reproductive Health Reviewers Response Reviewer #4 Dear authors Thank you for your revises. Please correct these two comments as well: • you record: the number of the painkiller used during 10 days. Many thanks for your valuable comments. Corrected. P 9. Par 3 • you add in the limitations that to assess wound healing, sterile tape was not used and visual inspection was used. With many respects to you, this sentence added to the limitation. P 14, par 3 Attachments Attachment Submitted filename: Response to Reviewers 4.docx https://doi.org/10.1371/journal.pone.0302161.r008
28 Mar 2024 Decision Letter - Ahmed Mohamed Maged, Editor Randomized Controlled Trial of the Effectiveness of Olive and Black Seed Oil Combination on Pain Intensity and Episiotomy Wound Healing in Primiparous Women: A Study Protocol PONE-D-23-34640R4 Dear Dr. Behmanesh, We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements. Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication. An invoice will be generated when your article is formally accepted. Please note, if your institution has a publishing partnership with PLOS and your article meets the relevant criteria, all or part of your publication costs will be covered. Please make sure your user information is up-to-date by logging into Editorial Manager at Editorial Manager® and clicking the ‘Update My Information' link at the top of the page. If you have any questions relating to publication charges, please contact our Author Billing department directly at authorbilling@plos.org. If your institution or institutions have a press office, please notify them about your upcoming paper to help maximize its impact. If they’ll be preparing press materials, please inform our press team as soon as possible -- no later than 48 hours after receiving the formal acceptance. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org. Kind regards, Ahmed Mohamed Maged, MD Academic Editor PLOS ONE Additional Editor Comments (optional): Reviewers' comments: https://doi.org/10.1371/journal.pone.0302161.r009
Formally Accepted
26 Apr 2024 Acceptance Letter - Ahmed Mohamed Maged, Editor PONE-D-23-34640R4 PLOS ONE Dear Dr. Behmanesh, I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now being handed over to our production team. At this stage, our production department will prepare your paper for publication. This includes ensuring the following: * All references, tables, and figures are properly cited * All relevant supporting information is included in the manuscript submission, * There are no issues that prevent the paper from being properly typeset If revisions are needed, the production department will contact you directly to resolve them. If no revisions are needed, you will receive an email when the publication date has been set. At this time, we do not offer pre-publication proofs to authors during production of the accepted work. Please keep in mind that we are working through a large volume of accepted articles, so please give us a few weeks to review your paper and let you know the next and final steps. Lastly, if your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org. If we can help with anything else, please email us at customercare@plos.org. Thank you for submitting your work to PLOS ONE and supporting open access. Kind regards, PLOS ONE Editorial Office Staff on behalf of Professor Ahmed Mohamed Maged Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0302161.r010

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