Music Therapy and Pain Management in Burn Patients.

NCT04571255 | Completed

• 1 other identifier: MTUCIA01
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized clinical trial studying the effectiveness of music therapy (i.e. MAR - Music-Assisted Relaxation) on pain intensity in burn patients hospitalized at the Adults Intensive Care Unit of the University Hospital Fundación Santa Fe de Bogotá in Colombia. Secondary outcome measures include anxiety and depression levels, vital signs, medication intake, quality of hospitalization and EEG, EMG, and ECG measurements. This is the first study in Colombia investigating the effectiveness of music therapy with this population.

Conditions

Burns; Pain

Keywords

music therapy; burn patients; intensive care; pain

Outcome Measures

Primary Outcomes (1)

• Change in pain intensity

  Measures the change in the perceived pain intensity with a Visual Analogue Scale from 0-10 with higher scores indicating higher pain and lower scores indicating less pain.

  Throughout study completion, up to 2 weeks after randomization.

Secondary Outcomes (6)

• Change in anxiety and depression levels

  Throughout study completion, up to 2 weeks after randomization.

• Changes in heart rate

  Throughout study completion, up to 2 weeks after randomization.

• Changes in respiratory rate

  Throughout study completion, up to 2 weeks after randomization.

• Changes in oxygen saturation

  Throughout study completion, up to 2 weeks after randomization.

• Medication intake

  Throughout study completion, up to 2 weeks after randomization.

Study Arms (2)

Intervention group

EXPERIMENTAL

Participants in the intervention group will receive a minimum of 3 and a maximum of 6 music therapy sessions (i.e. Music-Assisted Relaxation) during a two weeks time frame.

Behavioral: Music-Assisted Relaxation

Control Group

NO INTERVENTION

Treatment as usual.

Interventions

Music-Assisted Relaxation BEHAVIORAL

The music therapy sessions are based on MAR (Music-Assisted Relaxation), a music therapy technique that includes listening to live music, combined with deep diaphragmatic breathing and/or guided imagery relaxation. In a first step, the procedure will explained to the patient and he/she will be asked to close his/her eyes or focus on a fixed point on the ceiling or wall. Subsequently, a verbal introduction will be provided for fostering body and respiratory awareness. Then a mental image will be introduced (e.g., sitting on a beach watching the waves of the sea; being on top of a mountain looking at the horizon; imagining a safe and comfortable personalized place) and live music will be provided based on the principles of entrainment. The patient is asked to let himself/herself guide by the music and breath with the music while concentrating on the imagery. Once the music is over, the patient is again asked to become aware and the experience during the session will verbally discussed.

Also known as: Music Therapy

Intervention group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Burn patients of legal age.
• Estimated hospitalization of \> 8 days at the time of signing the informed consent.

You may not qualify if:

• Patients with known psychiatric disorders.
• Patients with cognitive disabilities.
• Mechanically ventilated and sedated patients.

Sponsors & Collaborators

• Fundación Santa Fe de Bogota: lead
• University of Los Andes, Columbia: collaborator

Study Sites (1)

Fundación Santa Fe de Bogotá

Bogotá, Bogota D.C., Colombia

Location

Related Publications (3)

• Ettenberger M, Maya R, Salgado-Vasco A, Cordoba-Silva JG, Amarillo M, Betancourt-Zapata W, Marin-Sanchez J, Gomez-Ortega V, Valderrama M. The effect of music therapy on background pain, anxiety, depression, vital signs, and medication usage in adult burn patients in the Intensive Care Unit: A randomized controlled trial. Burns. 2025 Sep;51(7):107587. doi: 10.1016/j.burns.2025.107587. Epub 2025 Jun 26.

  PMID: 40602276 DERIVED

• Cordoba-Silva J, Maya R, Valderrama M, Giraldo LF, Betancourt-Zapata W, Salgado-Vasco A, Marin-Sanchez J, Gomez-Ortega V, Ettenberger M. Music therapy with adult burn patients in the intensive care unit: short-term analysis of electrophysiological signals during music-assisted relaxation. Sci Rep. 2024 Oct 9;14(1):23592. doi: 10.1038/s41598-024-73211-3.

  PMID: 39384859 DERIVED

• Ettenberger M, Maya R, Salgado-Vasco A, Monsalve-Duarte S, Betancourt-Zapata W, Suarez-Canon N, Prieto-Garces S, Marin-Sanchez J, Gomez-Ortega V, Valderrama M. The Effect of Music Therapy on Perceived Pain, Mental Health, Vital Signs, and Medication Usage of Burn Patients Hospitalized in the Intensive Care Unit: A Randomized Controlled Feasibility Study Protocol. Front Psychiatry. 2021 Oct 18;12:714209. doi: 10.3389/fpsyt.2021.714209. eCollection 2021.

  PMID: 34733185 DERIVED

MeSH Terms

Conditions

Burns; Pain

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Mark Ettenberger, PhD

  Fundación Santa Fe de Bogotá

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinator Music Therapy

Study Record Dates

• First Submitted: May 29, 2020
• First Posted: September 30, 2020
• Study Start: November 1, 2020
• Primary Completion: July 24, 2024
• Study Completion: December 31, 2024
• Last Updated: January 27, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After publication
• Access Criteria: Based on aims and scope of further analysis

Locations

CO (1)