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

NCT06510153 | Recruiting DMC

• 1 other identifier: 046-24 UNV
• Study Type: interventional
• Target: 243
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Music Therapy; Recorded Music; Anxiety; Stress; Wellbeing; Emergency Care; Waiting Room

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Stress

  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)

  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

  The intervention will have a duration of twenty minutes. The WB-NRS will be administered prior to the intervention and immediately following its conclusion.

Study Arms (3)

Environmental Music Therapy

EXPERIMENTAL

Environmental Music Therapy (EMT) is a music therapy technique that uses live music to modulate the potentially stressful effects of the environment towards an atmosphere that provides a sense of comfort and security. The instruments used will be an acoustic guitar (Yamaha C-40), an ocean drum (a drum with a double skin on which small metal balls roll imitating the sound of the waves) and a Samafon (an instrument consisting of aluminum tubes of different sizes that are struck with a soft mallet producing long-lasting single or combined tones). 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. The music therapist will also use his/her voice, but without any lyrics or words. After approximately 20 minutes, the music therapist will gradually decrease the volume until the music stops.

Other: Environmental Music Therapy

Pre-recorded music

EXPERIMENTAL

The protocol for pre-recorded music is the same as for EMT, but instead of using live improvised music, a recording will be used that will consist of the same musical features and musical instruments as the live music. The recording will be made by the same music therapists who will perform the EMT intervention.

Other: Pre-recorded music

Standard care only

PLACEBO COMPARATOR

The control group will receive standard care in the emergency room waiting room as provided by each hospital, but without being exposed to EMT or pre-recorded music.

Other: Standard care only

Interventions

Environmental Music Therapy OTHER

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.

Environmental Music Therapy

Pre-recorded music OTHER

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

Pre-recorded music

Standard care only OTHER

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

Standard care only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients and caregivers/companions of legal age present in the emergency waiting room present during the intervention and control conditions.
• Patients whose triage does not represent immediate threat to life or severely ill patients (i.e., triage 3, 4 and 5)
• Patients and caregivers/companions with literacy skills.

You may not qualify if:

• Patients and caregivers/companions who report having hearing problems
• Patients and caregivers/companions with difficulties in understanding and/or filling out the questionnaires.
• Patients and/or caregivers/companions who do not consent to participate in the study.

Sponsors & Collaborators

• Claudia Aristizábal: lead
• Sanitas University: collaborator

Study Sites (2)

Clínica Iberoamérica

Barranquilla, Atlántico, Colombia

RECRUITING

Clínica Keralty Ibagué

Ibagué, Tolima Department, Colombia

RECRUITING

Related Publications (1)

• Hernandez A, Diaz AM, Moreno OF, Suarez R, Amarillo M, Moreno AM, Rios Suarez BA, Gomez Gonzalez LM, Cristancho Olaya GA, Ettenberger M. Effect of Live Environmental Music Therapy and Prerecorded Music on State Anxiety, Stress, Pain, and Well-Being Levels of Patients and Caregivers in the Emergency Department Waiting Room: Protocol for a Multicenter Randomized Clinical Trial. JMIR Res Protoc. 2025 Jun 18;14:e69131. doi: 10.2196/69131.

  PMID: 40531567 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Psychological Well-Being

Condition Hierarchy (Ancestors)

Mental Disorders; Personal Satisfaction; Behavior

Study Officials

• Mark Ettenberger, PhD

  keralty

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark Ettenberger, PhD

CONTACT

+57 311 2847635; mark.ettenberger@gmx.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 19, 2024
• Study Start: July 31, 2024
• Primary Completion: August 31, 2025
• Study Completion: September 30, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CO (2)