Study Protocol On “Effect Of Playing An Audio Clip For Pain And Anxiety Control For Burn Patients While Dressing Burn Wounds: Randomized Controlled Trial.

Abstract

Introduction:

Burn injuries cause significant pain and anxiety, especially during procedures like dressing changes. Current treatments often involve opioid and antianxiety medications, which may not fully alleviate discomfort. Music therapy, including patient-preferred audio, has emerged as a non-pharmacological option to address these challenges. This study assesses tailored audio interventions for burn patients in Qatar, where cultural preferences, such as Quranic recitations, may enhance therapeutic outcomes.

Research Methodology: This open-label randomized controlled trial will assess the effectiveness of listening to an audio clip as an adjunct to treatment as usual (TAU) among hospitalized burn patients. Eligible patients, meeting specific inclusion criteria, will be randomly assigned to either the intervention or control group, and outcomes related to pain and anxiety will be analyzed without blinding.

Results:  Descriptive statistics will summarize sample characteristics, with normally distributed data reported as mean (SD) and non-normally distributed data as median (IQR). Categorical data will be analyzed using Chi-square or Fisher’s exact test, and continuous data using unpaired t-tests or Mann-Whitney U tests. Multivariate regression will assess predictors for pain and anxiety scores.

Discussion: The primary outcomes of this study are reduced pain and anxiety levels during dressing changes, with a 15-20% reduction anticipated in the experimental group compared to the control group receiving treatment as usual. The secondary outcome is improved control of hemodynamic parameters (heart rate, respiratory rate, and blood pressure)& analgesic use in the experimental group compared to the control group.