Clinical trial NCT04571255: Music Therapy and Pain Management in Burn Patients.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burns
Pain
Keywords: music therapy
burn patients
intensive care
pain
Lead sponsor: Fundación Santa Fe de Bogota
Sponsor class: OTHER
Collaborators: name: University of Los Andes, Columbia
First posted: 2020-09-30
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in pain intensity
timeFrame: Throughout study completion, up to 2 weeks after randomization.
Secondary outcomes:
measure: Change in anxiety and depression levels
timeFrame: Throughout study completion, up to 2 weeks after randomization.
measure: Changes in heart rate
timeFrame: Throughout study completion, up to 2 weeks after randomization.
measure: Changes in respiratory rate
timeFrame: Throughout study completion, up to 2 weeks after randomization.
measure: Changes in oxygen saturation
timeFrame: Throughout study completion, up to 2 weeks after randomization.
measure: Medication intake
timeFrame: Throughout study completion, up to 2 weeks after randomization.
measure: Changes in Electroencephalography
timeFrame: Throughout study completion, up to 2 weeks after randomization.
Other outcomes:
Locations:
city: Bogotá
country: Colombia
facility: Fundación Santa Fe de Bogotá
state: Bogotá D.C.
Study officials:
affiliation: Fundación Santa Fe de Bogotá
name: Mark Ettenberger, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.