Study Results
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Basic Information
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COMPLETED
NA
82 participants
INTERVENTIONAL
2020-11-01
2024-12-31
Brief Summary
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Detailed Description
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Objectives: To investigate the effect of MAR (Music-Assisted Relaxation) on the perception of pain in burn patients at the AICU (Adult Intensive Care Unit) of the Fundación Santa Fe de Bogotá (FSFB). MAR is a music therapy technique that includes listening to live music, combined with deep diaphragmatic breathing and / or guided relaxation and the use of imagery. The music applied will be based on the principles of entrainment: first, the music is synchronized with the vital signs of the patients (e.g. respiratory rate) and then musical elements (e.g. tempo) are modulated to encourage the transition to a state of deep relaxation.
Methodology: This is a randomized controlled clinical trial with an intervention group and a parallel control group. The intervention group will receive a minimum of three music therapy sessions per week up to a maximum of two weeks (6 sessions). The control group will receive treatment as usual. The main outcome measure is the intensity of perceived pain and will be measured with a Visual Analogue Scale (VAS) before and after each session. Secondary measures are: levels of anxiety and depression (HADS - Hospital Anxiety and Depression Scale); vital signs (heart rate, respiratory rate, oxygen saturation); the use of analgesic medications (complementary or rescue doses); and the quality of hospitalization perceived by the patients. Additionally, in some patients EEG (Electroencephalogram), ECG (Electrocardiography) and EMG (Electromyography) measurements will be taken, as long as the medical condition allows it. The data collection will be carried out by blinded research assistants.
Analysis: Data analysis will be carried out by a statistician from the FSFB and in collaboration with the Department of Biomedical Engineering of the Universidad de los Andes. Taking a p value of less than 5% (0.05) as clinical significance, a univariate analysis will be performed initially. Subsequently, a multivariate analysis will be performed using logistic regression to establish the contribution of each of the variables studied.
Expected results: Successful pain management is one of the most important factors in the clinical outcome of burn patients. This is the first study in Colombia that seeks to determine the effectiveness of music therapy on pain management with this population. This study will help to broaden and deepen the scientific knowledge of music therapy in the area of critical care and will promote the acquisition of new knowledge and interdisciplinary research among the institutions involved.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Intervention group
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.
Music-Assisted Relaxation
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.
Control Group
Treatment as usual.
No interventions assigned to this group
Interventions
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Music-Assisted Relaxation
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Estimated hospitalization of \> 8 days at the time of signing the informed consent.
Exclusion Criteria
* Patients with cognitive disabilities.
* Mechanically ventilated and sedated patients.
18 Years
100 Years
ALL
No
Sponsors
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University of Los Andes, Columbia
OTHER
Fundación Santa Fe de Bogota
OTHER
Responsible Party
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Mark Ettenberger
Coordinator Music Therapy
Principal Investigators
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Mark Ettenberger, PhD
Role: PRINCIPAL_INVESTIGATOR
Fundación Santa Fe de Bogotá
Locations
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Fundación Santa Fe de Bogotá
Bogotá, Bogota D.C., Colombia
Countries
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References
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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.
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.
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.
Other Identifiers
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MTUCIA01
Identifier Type: -
Identifier Source: org_study_id
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