RESUMO
Background: Elevated anxiety levels are common in patients on mechanical ventilation (MV) and may challenge recovery. Research suggests music-based interventions may reduce anxiety during MV. However, studies investigating specific music therapy techniques, addressing psychological and physiological well-being in patients on MV, are scarce. Methods: This three-arm randomized clinical pilot study was conducted with MV patients admitted to the intensive care unit (ICU) of Hospital San José in Bogotá, Colombia between March 7, 2022, and July 11, 2022. Patients were divided into three groups: intervention group 1 (IG1), music-assisted relaxation; intervention group 2 (IG2), patient-preferred therapeutic music listening; and control group (CG), standard care. The main outcome measure was the 6-item State-Anxiety Inventory. Secondary outcomes were: pain (measured with a visual analog scale), resilience (measured with the Brief Resilience Scale), agitation/sedation (measured with the Richmond Agitation-Sedation Scale), vital signs (including heart rate, blood pressure, oxygen saturation, and respiratory rate), days of MV, extubation success, and days in the ICU. Additionally, three patients underwent electroencephalography during the interventions. Results: Data from 23 patients were analyzed in this study. The age range of the patients was 24.0-84.0 years, with a median age of 66.0 years (interquartile range: 57.0-74.0). Of the 23 patients, 19 were female (82.6%). No statistically significant differences between the groups were observed for anxiety (P=0.330), pain (P=0.624), resilience (P=0.916), agitation/sedation (P=0.273), length of ICU stay (P=0.785), or vital signs. A statistically significant difference between the groups was found for days of MV (P=0.019). Electroencephalography measurements showed a trend toward delta and theta band power decrease for two patients and a power increase on both beta frequencies (slow and fast) in the frontal areas of the brain for one patient. Conclusions: In this pilot study, music therapy did not significantly affect the anxiety levels in patients on MV. However, the interventions were widely accepted by the staff, patients, and caregivers and were safe, considering the critical medical status of the participants. Further large-scale randomized controlled trials are needed to investigate the potential benefits of music therapeutic interventions in this population.Trial Registration ISRCTN trial registry identifier: ISRCTN16964680.