Effect of Live Environmental Music Therapy and Prerecorded Music on State Anxiety, Stress, Pain, and Well-Being Levels of Patients and Caregivers in the Emergency Department Waiting Room: Protocol for a Multicenter Randomized Clinical Trial
Abstract
Background: Patients and caregivers attending emergency units often experience elevated levels of stress and anxiety. Music has been used in waiting rooms to reduce stress and anxiety, but existing studies on music therapy in emergency unit waiting areas are scarce and have limitations such as low statistical power and limited music selection.
Objective: The aim of this study is to determine the effect of live Environmental Music Therapy and prerecorded music on state anxiety, stress, pain, and well-being levels in patients and caregivers in the emergency unit waiting areas of 2 hospitals in Colombia.
Methods: This study is a multicenter randomized clinical trial, with 3 arms: standard care + live Environmental Music Therapy, standard care + prerecorded music, and standard care only. The primary outcome measure is the 6-item State-Trait Anxiety Inventory (STAI-6). Secondary outcome measures are pain and stress levels, both measured with Visual Analogue Scales (VAS), and well-being, measured with the Well-Being Numerical Rating Scales (WB-NRSs). The scales will be applied before and after each intervention. A total of 246 patients (82 in each arm) and 147 caregivers (49 in each arm) will be randomized.
Results: Data collection for this study started on September 3, 2024, and as of the submission of the study (November 2024), 216 patients and 134 caregivers have been enrolled. It is expected that the results will be available by May 2025.
Conclusions: This study seeks to…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 246 participants or records.
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