Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT06510153

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

Led by Claudia Aristizábal · Updated on 2024-09-19

243

Participants Needed

2

Research Sites

60 weeks

Total Duration

On this page

Sponsors

C

Claudia Aristizábal

Lead Sponsor

S

Sanitas University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients and caregivers who are 18 years or older and present in the emergency waiting room during the intervention or control conditions
  • Patients with triage levels 3, 4, or 5, indicating no immediate life threat or severe illness
  • Patients and caregivers with the ability to read and understand questionnaires
Not Eligible

You will not qualify if you...

  • Patients and caregivers who have hearing problems
  • Patients and caregivers who have difficulty understanding or completing questionnaires
  • Patients and caregivers who do not consent to participate in the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Clínica Iberoamérica

Barranquilla, Atlántico, Colombia

Actively Recruiting

2

Clínica Keralty Ibagué

Ibague, Tolima Department, Colombia

Actively Recruiting

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Research Team

M

Mark Ettenberger, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

3

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