- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04571255
Music Therapy and Pain Management in Burn Patients.
Music Therapy and Pain Management in Burn Patients at the Adults Intensive Care Unit of the University Hospital Fundación Santa Fe de Bogotá, Colombia.
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mark Ettenberger, PhD
- Phone Number: +573112847635
- Email: mark.ettenberger@gmx.at
Study Locations
-
-
Bogotá D.C.
-
Bogotá, Bogotá D.C., Colombia
- Recruiting
- Fundacion Santa Fe de Bogota
-
Contact:
- Mark Ettenberger, PhD
- Phone Number: 3112847635
- Email: mark.ettenberger@gmx.at
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Burn patients of legal age.
- Estimated hospitalization of > 8 days at the time of signing the informed consent.
Exclusion Criteria:
- Patients with known psychiatric disorders.
- Patients with cognitive disabilities.
- Mechanically ventilated and sedated patients.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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 Names:
|
No Intervention: Control Group
Treatment as usual.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Throughout study completion, up to 2 weeks after randomization.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in anxiety and depression levels
Time Frame: Throughout study completion, up to 2 weeks after randomization.
|
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.
|
Throughout study completion, up to 2 weeks after randomization.
|
Changes in heart rate
Time Frame: Throughout study completion, up to 2 weeks after randomization.
|
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.
|
Throughout study completion, up to 2 weeks after randomization.
|
Changes in respiratory rate
Time Frame: Throughout study completion, up to 2 weeks after randomization.
|
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.
|
Throughout study completion, up to 2 weeks after randomization.
|
Changes in oxygen saturation
Time Frame: Throughout study completion, up to 2 weeks after randomization.
|
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.
|
Throughout study completion, up to 2 weeks after randomization.
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Medication intake
Time Frame: Throughout study completion, up to 2 weeks after randomization.
|
complementary or rescue dosis asked for by the patient
|
Throughout study completion, up to 2 weeks after randomization.
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Changes in Electroencephalography
Time Frame: Throughout study completion, up to 2 weeks after randomization.
|
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.
|
Throughout study completion, up to 2 weeks after randomization.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Mark Ettenberger, PhD, Fundacion Santa Fe de Bogota
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MTUCIA01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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