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.