RecruitingNot ApplicableNCT06510153

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

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 Unit Waiting Area: A Multi-Center Randomized Clinical Trial Study Protocol


Sponsor

Claudia Aristizábal

Enrollment

243 participants

Start Date

Jul 31, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is examining whether live music therapy or pre-recorded music played in the emergency department waiting room reduces anxiety and stress in patients and their family members or companions who are waiting for care. It compares music conditions against a silent waiting room. **You may be eligible if...** - You are 18 years or older and are a patient or companion present in the emergency waiting room during the study periods - Your condition is not immediately life-threatening (triage categories 3, 4, or 5) - You are able to read and complete a short survey **You may NOT be eligible if...** - You have hearing problems - You have difficulty understanding or completing questionnaires - You do not consent to participate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHEREnvironmental 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.

OTHERPre-recorded music

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

OTHERStandard care only

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


Locations(2)

Clínica Iberoamérica

Barranquilla, Atlántico, Colombia

Clínica Keralty Ibagué

Ibague, Tolima Department, Colombia

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NCT06510153


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