Review question

The systematic review and meta-analysis will seek to address the following main research question: Does music have impact on the anxiety and physiological outcomes of patients undergoing bronchoscopy?

Eligibility criteria

The research question is formulated using the PICOS (Population, Intervention, Comparison, Outcome, Study design) model [28]. The eligibility criteria for study inclusion will be defined based on the PICOS framework as follows:

• Population (P): Adult patients aged 18 years or older undergoing bronchoscopy.
• Intervention (I): studies involving the use of music before and/or during bronchoscopy as an intervention regardless of the type of music or method of delivery will be included.
• Comparison (C): Comparative groups will include those receiving standard care without a music intervention or another non-pharmacological intervention.
• Outcome(O): The primary outcome of interest will be the level of patient anxiety as measured by the State-Trait Anxiety Inventory (STAI) or other validated scales (such as Visual Analog Scale (VAS) and physiological outcomes such as heart rate (HR), arterial pressure, oxygen saturation (O₂ sat), and pain score.
• Study design (S): RCTs published in any language will be included. Only completed RCTs will be included. There will be no restrictions on the study setting, country of origin, or publication date.

Studies will be excluded if the intervention involves another non-pharmacological method in addition to music or if they assess multimodal interventions where the specific effect of music cannot be isolated. Additionally, quasi-experimental studies, observational studies, case studies, editorials, letters to the editor, and conference abstracts will be excluded. Studies without a comparison group or without at least one measurement of pain score, anxiety score, or physiological parameters will also be excluded.

Search strategy

An electronic search will be conducted across four reputable databases: Medline via PubMed, google scholar, Scopus and the Cochrane library, from their inception. The search will be updated periodically to ensure all relevant articles are included before finalizing the study results. We developed search strategies using a combination of Medical Subject Headings (MeSH) terms and synonyms related to music, bronchoscopy, anxiety and physiological parameters and tailored to each specific database (Table 1). Boolean operators ‘AND’ and ‘OR’ will be used.

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Table 1. Search terms.

https://doi.org/10.1371/journal.pone.0313833.t001

The preliminary PubMed search strategy is as follows:

(music OR music therapy) AND (bronchoscopy) AND ((anxiety OR stress, psychological OR anxiety disorders) OR (pain OR patient comfort) OR (heart rate OR pulse rate OR cardiac rate) OR (blood pressure OR arterial pressure OR diastolic pressure OR systolic pressure) OR (oxygen saturation OR blood oxygen level) OR (vital signs)). this search query will be adapted to the other databases. The complete database search strategy is presented in S1 Appendix. In Google scholar, the search results will be sorted by relevance and only the first 10 pages of the search results will be examined using the same terms.

In addition to searching electronic databases, the reference lists of all included articles will be carefully examined to uncover any additional relevant studies.

Study selection

The search results from each database will be combined and duplicates will be removed using Zotero bibliographic software. Studies will then be screened independently by two reviewers (AK and DC in the authors’ list). Any disagreements will be discussed, and if a consensus could not be reached, a third reviewer (SA in the authors’ list) will be consulted. Initially, the titles of the studies will be independently screened by the two reviewers to assess their relevance to the research question. Subsequently, the abstracts will be reviewed to ensure they meet the inclusion criteria. Articles with abstracts that satisfy these criteria will then undergo a thorough full-text review to determine their eligibility for inclusion in the systematic review. The PRISMA flow diagram will be used to provide a detailed description of the study selection process for the systematic review (Fig 1).

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Fig 1. Flow diagram of study selection.

https://doi.org/10.1371/journal.pone.0313833.g001

Data extraction

Data will be meticulously extracted from all eligible studies by two independent investigators (AK and DC in the authors’ list) using a predesigned data extraction form in Microsoft Excel to ensure precision and consistency. The extracted data will be then subjected to a thorough verification process by a third author (SA in the authors’ list) to ensure its accuracy and completeness. The following key information will be extracted from each study:

• Study Identification: First author, year of publication, country.
• Participants Characteristics: Demographic data such as age distribution, sex, and any inclusion/exclusion criteria applied.
• Study Design: Sample size, setting, and duration of follow-up.
• Intervention Details: Specifics of the music intervention, including type of music, duration, timing relative to the bronchoscopy procedure, delivery method, and any concurrent interventions.
• Comparison Group: Description of the control or comparison group (e.g., standard care, another non-pharmacological intervention).
• Outcomes: Primary and secondary outcome measures.
• Results: Key findings related to the impact of the music intervention on the specified outcomes.

After data extraction, one investigator will compile a summary of the data to consolidate the findings from the two investigators.

Methodological quality assessment

To evaluate the methodological quality of the included studies, the Joanna Briggs Institute (JBI) critical appraisal tool will be used. This tool rates different parts of the study quality as "yes", "no", "unclear", or "not applicable." [29]. To ensure reliability, two investigators (AK and DC) will independently apply the JBI checklist to each study. Any discrepancies will be resolved through discussion, with a third investigator (SA). The percentage of affirmative responses to the checklist items (Table 2) will determine the final quality score for each study. Studies will then be classified into one of three categories based on their scores: "high risk of bias" (with affirmative responses up to 49%), "moderate risk of bias" (with affirmative responses ranging from 50% to 69%), or "low risk of bias" (with affirmative responses exceeding 70%) [30].

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Table 2. JBI items.

https://doi.org/10.1371/journal.pone.0313833.t002

If an article lacks or has insufficient data, basic information will be emailed to the relevant authors. Studies will be excluded if contact is not established, or the data is insufficient.

Grading of evidence

The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) method will be used to assess the quality of evidence for each intervention, rating it as high, moderate, low, or very low [31]. This process will be conducted via the GradePro software. A summary of findings table will present primary and secondary outcomes, along with the risk of publication bias. Evidence rated as low or very low will be highlighted in the conclusion, guiding careful clinical decision-making and interpretation of music’s effect on anxiety and physiological outcomes during bronchoscopy.

Missing data

If an article lacks or has insufficient data, basic information will be emailed to the relevant authors. Data will be excluded from the quantitative analysis if contact is not established after two attempts, or if the data remains insufficient. However, if appropriate, an imputation strategy will be performed to handle missing data.

Statistical analysis

Data from the included studies will be synthesized quantitatively using a random-effects model to account for variability both within and between studies. Effect sizes will be calculated for each outcome, such as anxiety levels and physiological parameters, and reported as standardized mean differences (SMD) with 95% confidence intervals (CIs). Heterogeneity across studies will be assessed using Cochran’s Q test and the I² statistic, with I² values of 25%, 50%, and 75% representing low, moderate, and high heterogeneity, respectively. If substantial heterogeneity is detected, and sufficient data are available, subgroup analyses based on age, sex ratio, in patient/outpatient, type of sedation and operator, will be conducted to explore potential sources of variability. Additionally, a sensitivity analysis will be performed to assess the robustness of the results. In cases where more than ten studies are included, publication bias will be evaluated using a funnel plot and Egger’s test. All statistical analyses will be performed using R software Version 4.4.1.

Ethics and dissemination

The systematic review and meta-analysis will utilize publicly available literature and data. Hence, This research is exempt from ethical review. The results will be published in a peer-reviewed journal. Any changes to the protocol will be registered in the PROSPERO database (registration number CRD42024567398), and the updated version will accompany the final systematic review.

Timeline

We expect to finalize the search, screening, data extraction, and synthesis processes by late September 2024.