Accepted for/Published in: JMIR Research Protocols
Date Submitted: Nov 22, 2024
Date Accepted: Apr 22, 2025
The effect of live environmental music therapy and pre-recorded music on state-anxiety, stress, pain, and wellbeing levels of patients and caregivers in the emergency department waiting room: a multicenter randomized clinical trial protocol
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 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 (EMT) and pre-recorded music on state-anxiety, stress, pain and well-being levels in patients and caregivers in the emergency unit waiting areas of two hospitals in [country, de-identified for peer review].
Methods:
This study is a multicenter randomized clinical trial, with three arms: standard care + live EMT, standard care + pre-recorded music, and standard care only. The primary outcome measure is the six-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. This study was approved by the Research Ethics Committee of the Fundación Universitaria Sanitas (CEIFUS 1779-24, date of approval: June 18th, 2024).
Results:
Data collection for this study started on September 10th, 2024 it is expected that data collection will be finished by December 2024 or January 2025. As of November 22nd, a total of 225 patients and 134 caregivers were enrolled.
Conclusions:
This study seeks to contribute to improving mental health, wellbeing, and quality of care of patients and caregivers in the waiting area of the emergency units. This is the first study in [country, de-identified for peer review] investigating the effect of live music therapy and pre-recorded music interventions in the emergency department. Clinical Trial: Clinicaltrials.gov (NCT06510153), registration date: July 19th, 2024. URL: https://clinicaltrials.gov/study/NCT06510153
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