Clinical Trial

Music Therapy and Pre-recorded Music on Patients and Caregivers in the Emergency Unit

Recruiting
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Record status
This record was last updated September 19, 2024 (before its estimated August 31, 2025 completion). Its status may not reflect the trial's current state.
Summary
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. 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 Colombia. This study is a multi-center 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 a 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. 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 Colombia investigating the effect live music therapy and pre-recorded music interventions in the emergency department.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-07-18.
Status change: Not Yet Recruiting → Recruiting 2024-09-04
Trial Details
NCT Number NCT06510153
Lead Sponsor Claudia Aristizábal
Collaborators: Sanitas University
Conditions Anxiety, Stress, Well-Being, Psychological
Enrollment 243 participants
Start Date 2024-07-31
Primary Completion 2025-08-31 (estimated)
Study Completion 2025-09-30 (estimated)
Updated on ClinicalTrials.gov 2024-09-19