Virtual reality vs. Tablet video for venipuncture education in children: A randomized clinical trial

Jiyoun Lee; Jung-Hee Ryu; Soo Hyun Seo; Sunghee Han; Jin-Woo Park

doi:10.1371/journal.pone.0307488

Peer Review History

Original SubmissionJanuary 25, 2024
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Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented. Reviewer #1: Yes Reviewer #2: Yes ******** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes Reviewer #2: No ****** 3. Have the authors made all data underlying the findings in their manuscript fully available? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). 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: Yes ****** 4. 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: Yes Reviewer #2: Yes ****** 5. Review Comments to the Author Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: I have had the great opportunity to review your article, and overall, it provides valuable insights into your field. However, I would like to request some clarifications and additional details, particularly in the Methods section. Firstly, could you elaborate more on the study protocol in the Methods section? While it is mentioned that a single-blinded researcher measured the CHEOP score and outcomes, I am curious about the actual study procedures. For instance, did children experience virtual reality or watch conventional videos in separate room and move to phlebotomy unit afterward? Additionally, what was the time interval between education and venipuncture? Also, one minor thing about your supplement data ‘protocol.docx’. While the total number of children is correctly indicated as 90, there seems to be an inconsistency in the allocation to both groups, where each is designated as 30. Also, to establish the similarity between both groups, I recommend including p-values in Table 1 to support the claim about their comparable characteristics. I observed that the satisfaction scores from guardians were uniformly high, with most participants seems like giving a score of 10/10 in both groups. Given the limited variability in satisfaction scores, traditional statistical analyses may not be well-suited for such uniform data. I am interested in understanding the statistical approach used to assess and compare these high satisfaction scores. Moreover, considering the near-universal high ratings, it raises a broader question about the meaningfulness of comparing satisfaction levels between the two groups. Regarding the excluded patients, the figure 1 flowchart displays only those who did not agree to consent, while you mentioned other exclusion criteria. To adhere to the CONSORT guidelines, could you refine the number of excluded children in the flowchart accordingly? Moreover, I am interested in understanding the reasoning behind excluding children with a history of venipuncture in the previous year. Could you provide further details on this aspect? Concerning the CHEOP score, I would appreciate it if you could clarify your rationale for dividing the score into three categories (mild/moderate/severe) and provide the reference for this categorization. Additionally, why did you choose the CHEOP score over other pain scale systems for children? Given that the CHEOP score was initially designed for children aged 1 to 5 years old and those who are postoperative, could you provide more explanation and references on why you specifically chose this scoring system? Thank you for your time and attention to these queries. Your clarification on these points will contribute to a more comprehensive understanding of your study. Reviewer #2: What test was used for the sample size calculation? Is that a two-sample t-test? Why not use Mann-Whitney as the primary analysis does? Can you calculate a Spearman correlation between VAS and the pain scale, overall and by education group? Is there a significant interaction between VAS and group in the regression? ****** 6. 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: 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.0307488.r001
Revision 1
15 Apr 2024 Author Response Reviewer 1 1) Firstly, could you elaborate more on the study protocol in the Methods section? While it is mentioned that a single-blinded researcher measured the CHEOP score and outcomes, I am curious about the actual study procedures. For instance, did children experience virtual reality or watch conventional videos in separate room and move to phlebotomy unit afterward? Additionally, what was the time interval between education and venipuncture? Also, one minor thing about your supplement data ‘protocol.docx’. While the total number of children is correctly indicated as 90, there seems to be an inconsistency in the allocation to both groups, where each is designated as 30. Answer) Thank you for your kind feedback. We performed the interventions in an independent room separated from the phlebotomy unit, and there was an interval of 5 min or less between education and venipuncture. We have provided additional explanations in the Methods section as follows. “Another independent researcher received a sealed envelope with the randomization number and performed the intervention in an independent room separated from the phlebotomy unit.” (page: 6) “Immediately after the VR or video session, the patients were moved to the phlebotomy unit for venipuncture. The interval from the end of education to the positioning at the phlebotomy desk did not exceed 5 min.” (page: 7) We have also added the description to “protocol.docx”. 2) Also, to establish the similarity between both groups, I recommend including p-values in Table 1 to support the claim about their comparable characteristics. Answer) Thank you for your suggestion. P-values have been included as advised. 3) I observed that the satisfaction scores from guardians were uniformly high, with most participants seems like giving a score of 10/10 in both groups. Given the limited variability in satisfaction scores, traditional statistical analyses may not be well-suited for such uniform data. I am interested in understanding the statistical approach used to assess and compare these high satisfaction scores. Moreover, considering the near-universal high ratings, it raises a broader question about the meaningfulness of comparing satisfaction levels between the two groups. Answer) Thank you for the advice. In fact, we drew attention to the fact that the results were contrary to those of a previous study that showed a significant difference in parental satisfaction between the VR group and the control group which received simple verbal education. Compared using different approaches, there was no significant difference in the parental satisfaction between the two groups. Active multimedia education to reduce procedural pain in pediatric patients might increase the satisfaction of the parents, in both groups. We added the description in the discussion section as follows. “These results are contrary to those of a previous study that showed a significant difference in parental satisfaction between the VR group and the control group which received simple verbal education [15]. Active multimedia education to reduce procedural pain in pediatric patients might increase the satisfaction of the parents, in both groups.” (page: 14, line: 5-9) 4) Regarding the excluded patients, the figure 1 flowchart displays only those who did not agree to consent, while you mentioned other exclusion criteria. To adhere to the CONSORT guidelines, could you refine the number of excluded children in the flowchart accordingly? Answer) Thank you for your kind clarification. Upon review, I have found that the figure missing the excluded patients has been incorrectly registered. I will attach the newly revised Figure 1 flow chart. The "Patient" section in the Methods has also been updated accordingly. Thank you. 5) Moreover, I am interested in understanding the reasoning behind excluding children with a history of venipuncture in the previous year. Could you provide further details on this aspect? Answer) We appreciated the comment. When we planned the research, we hypothesized that if children had prior experience with the same procedure within the last year, it could potentially influence their perception of pain and anxiety associated with the procedure, either positively or negatively. To minimize any bias, children with the history were excluded from the study, as we did in our previous studies regarding VR experiential education. 6) Concerning the CHEOP score, I would appreciate it if you could clarify your rationale for dividing the score into three categories (mild/moderate/severe) and provide the reference for this categorization. Additionally, why did you choose the CHEOP score over other pain scale systems for children? Given that the CHEOP score was initially designed for children aged 1 to 5 years old and those who are postoperative, could you provide more explanation and references on why you specifically chose this scoring system? Answer) Thank you for the comment. In our current study, it was revealed that there is a statistically significant difference in CHEOP scores between the two groups. While this statistical difference is important, we also divided the data into thirds to visually demonstrate the distribution of pain among the children. There is no specific rationale for this division. The CHEOPS (1) was developed for use in the postoperative setting for children one to 12 years of age, but has been applied to other acute pain situations, such as immunizations (2,3), venipuncture (4,5), fracture reduction (6) and laceration repair (7). CHEOPS has included the age range of our study, and is one of the most used behavioral assessment tools to evaluate pain caused by venipuncture in previous research. Accordingly, we decided to use CHEOPS in this study, as we did in our previous study (8). 1. McGrath PJ, Johnson G, Goodman JT, Dunn J, Chapman J. CHEOPS: A behavioral scale for rating postoperative pain in children. In: Fields HL, Dubner R, Cervero F, editors. Advances in Pain Research and Therapy. New York: Raven Press; 1985. pp. 395–402. 2. Cassidy KL, Reid GJ, McGrath PJ, et al. Watch needle, watch TV: Audiovisual distraction in preschool immunization. Pain Med. 2002;3:108–18. 3. Cassidy KL, Reid GJ, McGrath PJ, Smith DJ, Brown TL, Finley GA. A randomized double-blind, placebo-controlled trial of the EMLA patch for the reduction of pain associated with intramuscular injections in four to six-year-old children. Acta Paediatr. 2001;90:1329–36. 4. Galinkin JL, Rose JB, Harris K, Watcha MF. Lidocaine iontophoresis versus eutectic mixture of local anesthetics (EMLA) for IV placement in children. Anesth Analg. 2002;94:1484–8. 5. Van-Cleve L, Jonson L, Pothier P. Pain responses of hospitalized infants and children to venipuncture and intravenous cannulation. J Pediatr Nurs. 1996;11:161–7. 6. McCarty EC, Mencio GA, Walker LA, Green NE. Ketamine sedation for the reduction of children’s fractures in the emergency department. J Bone Joint Surg Am. 2000;82:912–8. 7. Klein EJ, Diekema DS, Paris CA, Quan L, Cohen M, Seidel KD. A randomized, clinical trial of oral midazolam plus placebo versus oral midazolam plus oral transmucosal fentanyl for sedation during laceration repair. Pediatrics. 2002;109:894–7. 8. Ryu JH, Han SH, Hwang SM, Lee J, Do SH, Kim JH, et al. Effects of Virtual Reality Education on Procedural Pain and Anxiety During Venipuncture in Children: A Randomized Clinical Trial. Front Med (Lausanne) 2022;9:849541. Reviewer 2 1) What test was used for the sample size calculation? Is that a two-sample t-test? Why not use Mann-Whitney as the primary analysis does? Answer) Thank you for the comment. We used a two-sample t-test to calculate the sample size. This was because that the number of samples in our study was 45 people per group, so we expected CHEOPS score to show normal distribution. However, the variable did not satisfy normal distribution, so the Mann-Whitney test was used for statistical analysis instead. Of course, even if Mann-Whitney was used to calculate the sample size, there would not have been a sufficient difference in the total number of participants, and the statistical results would not have been different from the current results. 2) Can you calculate a Spearman correlation between VAS and the pain scale, overall and by education group? Is there a significant interaction between VAS and group in the regression? Answer) As you recommended, we performed Spearman correlation analysis between baseline pain expectation (VAS) and the CHEOPS. We found a positive and significant correlation; the Spearman correlation coefficient was 0.477 (P < 0.001). We also performed Spearman correlation analysis between overall and by education group. Except for CHEOPS, no variables showed significant correlation with education group. The Spearman correlation coefficient between the education group and pain expectation (VAS) was -0.012 (P = 0.912). Attachments Attachment Submitted filename: response to reviewers.docx https://doi.org/10.1371/journal.pone.0307488.r002
7 Jul 2024 Decision Letter - Cho Lee Wong, Editor Virtual Reality vs. Tablet Video for Venipuncture Education in Children: A Randomized Clinical Trial PONE-D-24-02483R1 Dear Dr. Park, 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, Cho Lee Wong, PhD Academic Editor PLOS ONE Additional Editor Comments (optional): Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation. Reviewer #1: All comments have been addressed Reviewer #2: All comments have been addressed ******** 2. Is the manuscript technically sound, and do the data support the conclusions? The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented. Reviewer #1: Yes Reviewer #2: (No Response) ****** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes Reviewer #2: (No Response) ****** 4. Have the authors made all data underlying the findings in their manuscript fully available? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). 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 Response) ****** 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 Response) ****** 6. Review Comments to the Author Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: (No Response) Reviewer #2: All my comments are addressed. The statistics is acceptable. ****** 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: No ******** https://doi.org/10.1371/journal.pone.0307488.r003
Formally Accepted
17 Jul 2024 Acceptance Letter - Cho Lee Wong, Editor PONE-D-24-02483R1 PLOS ONE Dear Dr. Park, 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 Dr. Cho Lee Wong Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0307488.r004

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