Music Therapy and Pre-recorded Music on Patients and Caregivers in the Emergency Unit
NCT Number: NCT06510153
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Anxiety|Stress|Well-Being, Psychological
Interventions: OTHER: Environmental Music Therapy|OTHER: Pre-recorded music|OTHER: Standard care only
Sponsor: Claudia Aristizábal
Collaborators: Sanitas University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 243
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-07-31
Completion Date: 2025-09-30
Locations: Clínica Iberoamérica, Barranquilla, Atlántico, Colombia|Clínica Keralty Ibagué, Ibagué, Tolima, Colombia

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.

Primary Outcome Measures: State-anxiety, It will be measured with the Spanish version of the state scale of the six-item State-Trait Anxiety Inventory (STAI-6) scored on a Likert scale from 1 "absence of anxiety" to 4 "high anxiety"., The intervention will have a duration of twenty minutes. The STAI-6 will be administered prior to the intervention and immediately following its conclusion.
Secondary Outcome Measures: Stress, Stress levels will be measured by the Visual Analogue Stress Scale (VAS-S). The VAS-S consists of a 10-centimeter line divided into 10 points, each separated by 1 centimeter. 0 means the complete absence of stress and 10 the maximum possible stress. A cut-off of 7 points has been established as a significant stress level., The intervention will have a duration of twenty minutes. The VAS-S will be administered prior to the intervention and immediately following its conclusion.|Pain (patients only), Perceived pain levels by patients will be measured with the Visual Analogue Pain Scale (VAS-P) consisting of a line of 10 centimeters divided into 10 points, each separated by 1 centimeter, where 0 means complete absence of pain and 10 the maximum possible pain., The intervention will have a duration of twenty minutes. The VAS-P will be administered prior to the intervention and immediately following its conclusion.|Wellbeing, Well-being will be measured by the Well-being Numerical Rating Scales (WB-NRSs) consisting of a line divided into numbers from 1 to 10, where 1 indicates a state of absolute distress, and 10 a state of absolute well-being., The intervention will have a duration of twenty minutes. The WB-NRS will be administered prior to the intervention and immediately following its conclusion.