Music Therapy and Pain Management in Burn Patients.
Music Therapy and Pain Management in Burn Patients.
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.
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.
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.