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

NCT06510153 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 243

Last updated 2024-09-19

No results posted yet for this study

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.

Conditions

  • Anxiety
  • Stress
  • Well-Being, Psychological

Interventions

OTHER

Environmental Music Therapy

The music will consist of improvised music at a slow to moderate tempo, using free-flowing melodies, and simple chord progressions, focusing on creating moments of tension and resolution during approximately 20 minutes.

OTHER

Pre-recorded music

The protocol for pre-recorded music is the same as for EMT.

OTHER

Standard care only

Standard care in the emergency room waiting room as provided by each hospital without being exposed to EMT or pre-recorded music.

Sponsors & Collaborators

  • Sanitas University

    collaborator OTHER
  • Claudia Aristizábal

    lead OTHER

Principal Investigators

  • Mark Ettenberger, PhD · keralty

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-07-31
Primary Completion
2025-08-31
Completion
2025-09-30

Countries

  • Colombia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06510153 on ClinicalTrials.gov