BurnsNCT04571255
Music Therapy and Pain Management in Burn Patients.
A study testing Music-Assisted Relaxation in people with Burns and Pain, run by Fundación Santa Fe de Bogota at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- What is being tested?
- Music-Assisted Relaxation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteColombia
- Study dates
- 1 Nov 2020to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Burn patients of legal age.
- Estimated hospitalization of > 8 days at the time of signing the informed consent.
Who cannot join
- Patients with known psychiatric disorders.
- Patients with cognitive disabilities.
- Mechanically ventilated and sedated patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Music Therapy and Pain Management in Burn Patients At the Adults Intensive Care Unit of the University Hospital Fundación Santa Fe De Bogotá, Colombia.
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.
Read the detailed description
Introduction: Pain management is one of the greatest challenges in the critical care of burn patients and is frequently associated with high levels of anxiety and depression. Several studies and meta-analyses confirm the effectiveness of music interventions and music therapy in changing the experience of pain in hospitalized patients, but further clinical trials are needed investigating specific music therapy interventions in addressing pain in burn patients.
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.
- Being tested
- Music-Assisted Relaxation
- Keywords
- music therapy, burn patients, intensive care, pain
- Medical subject headings
- Burns, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music-Assisted RelaxationBehavioural
Also called Music Therapy
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Music-Assisted Relaxation |
| Control Group | No intervention | Treatment as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Throughout study completion, up to 2 weeks after randomization.
Secondary outcomes (6)
Change in anxiety and depression levels
Measures changes in anxiety and depression levels with the Hospital Anxiety and Depression Scale from 0 to 21 total scores. Higher scores indicate higher levels of anxiety and depression and lower scores indicate lower levels of anxiety and depression.
Measured: Throughout study completion, up to 2 weeks after randomization.
Changes in heart rate
Measures changes in heart rate via hospital monitors. These are changes in bpm (beats per minute) and will be averaged during a 10 minutes pre-intervention phase, during the interventions and a 10 minutes post-intervention phase.
Measured: Throughout study completion, up to 2 weeks after randomization.
Changes in respiratory rate
Measures changes in respiratory rate via hospital monitors. These are changes in bpm (breaths per minute) and will be averaged during a 10 minutes pre-intervention phase, during the interventions and a 10 minutes post-intervention phase.
Measured: Throughout study completion, up to 2 weeks after randomization.
Changes in oxygen saturation
Measures changes in arterial oxygen saturation (SaO2) via pulse oximetry. These are changes in percentage (%) of arterial oxygen saturation and will be averaged during a 10 minutes pre-intervention phase, during the interventions and a 10 minutes post-intervention phase.
Measured: Throughout study completion, up to 2 weeks after randomization.
Medication intake
complementary or rescue dosis asked for by the patient
Measured: Throughout study completion, up to 2 weeks after randomization.
Changes in Electroencephalography
Measures changes in the electrical activity of brain regions with the MicroMed 64. Measurements of the change in activity in the theta (4-8 Hz), alpha (8-12 Hz), beta 1 (12-18 Hz) and beta 2 (18-30 Hz) physiological bands will be taken from the electroencephalography records. The set up will be carried out according to international assembly 10-20, but the number of electrodes will depend on the location of the burns and the approval of the treating doctor according to each patient.
Measured: Throughout study completion, up to 2 weeks after randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2020
- Study start1 Nov 2020
- Primary completion24 Jul 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Santa Fe de Bogota
- Sponsor type
- University, hospital or other
- Collaborators
- University of Los Andes, Columbia
- Responsible party
- Principal investigator, Mark Ettenberger, Fundación Santa Fe de Bogota
- Investigators
- Mark Ettenberger, PhD, Principal investigator, Fundación Santa Fe de Bogotá
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04571255
- Sponsor's protocol ID
- MTUCIA01
- Status last verified
- Dec 2024
- First submitted
- 29 May 2020
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Publications
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.
PubMed 40602276Cordoba-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.
PubMed 39384859Ettenberger 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.
PubMed 34733185
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Music Therapy and Pain Management in Burn Patients At the Adults Intensive Care Unit of the University Hospital Fundación Santa Fe De Bogotá, Colombia.
- ClinicalTrials.gov ID
- NCT04571255
- Acronym / sponsor ID
- MTUCIA01
- Keywords
- music therapy, burn patients, intensive care, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Fundación Santa Fe de BogotaUniversity, hospital or other
- Collaborators
- University of Los Andes, Columbia
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 24 Jul 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 30 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Introduction: Pain management is one of the greatest challenges in the critical care of burn patients and is frequently associated with high levels of anxiety and depression. Several studies and meta-analyses confirm the effectiveness of music interventions and music therapy in changing the experience of pain in hospitalized patients, but further clinical trials are needed investigating specific music therapy interventions in addressing pain in burn patients.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Music-Assisted RelaxationParticipants 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. |
| Control Group | No intervention | –Treatment as usual. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Burn patients of legal age.
- Estimated hospitalization of > 8 days at the time of signing the informed consent.
Key exclusion criteria (3 listed)
- Patients with known psychiatric disorders.
- Patients with cognitive disabilities.
- Mechanically ventilated and sedated patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music-Assisted RelaxationAlso: Music TherapyThe 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. | Behavioural | Intervention group |
Primary outcome
Change in pain intensity
Time frame: Throughout study completion, up to 2 weeks after randomization.
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.
6 secondary outcomes
Change in anxiety and depression levels
Time frame: Throughout study completion, up to 2 weeks after randomization.
Changes in heart rate
Time frame: Throughout study completion, up to 2 weeks after randomization.
Changes in respiratory rate
Time frame: Throughout study completion, up to 2 weeks after randomization.
Changes in oxygen saturation
Time frame: Throughout study completion, up to 2 weeks after randomization.
Medication intake
Time frame: Throughout study completion, up to 2 weeks after randomization.
Changes in Electroencephalography
Time frame: Throughout study completion, up to 2 weeks after randomization.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
- Derived from this study: PubMed 40602276Ettenberger 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.
- Derived from this study: PubMed 39384859Cordoba-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.
- Derived from this study: PubMed 34733185Ettenberger 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.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Ettenberger, PhD principal investigator
Fundación Santa Fe de Bogotá
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music-Assisted Relaxation in people with Burns and Pain, run by Fundación Santa Fe de Bogota at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain intensity (time frame: Throughout study completion, up to 2 weeks after randomization.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04571255, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025; AzTrials last refreshed its copy on 7 Nov 2026.