Education and Music Intervention to Reduce Anxiety: feasibility, potential efficacy, and patient satisfaction in a pilot study.

BACKGROUND: People undergoing cardiac catheterization experience anxiety. Musical and educational interventions have been tested separately and have been shown to reduce anxiety in this patient profile. This pilot study aimed to assess the feasibility and potential effectiveness of a complex intervention called Education and Music Intervention to Reduce Anxiety (EMIRA), in addition to participant credibility, expectations and satisfaction. METHODS: This is a randomized, blind, pilot clinical trial, carried out in an emergency department specializing in cardiology. Feasibility was assessed according to recruitment, retention, attrition and recruitment time rates. The potential for efficacy was assessed through the effect of EMIRA on state anxiety, blood pressure, heart rate, respiratory rate and chest pain intensity, comparing the intervention group (IG) and control group (CG) before (T1), immediately after (T2) and two to four hours after (T3) the intervention. To estimate participant satisfaction with the intervention, a visual numerical scale was used. Participant credibility and expectations regarding EMIRA were determined using a previously validated instrument. No hypothesis testing was conducted. RESULTS: A total of 47 potential participants were approached over a period of 54 days. Recruitment, retention, and attrition rates were, respectively, 93.6%, 90.9%, and 10%. No participants dropped out after enrollment. Descriptive analysis showed reductions in anxiety scores and physiological parameters over time in both groups, but no consistent trends favoring the intervention were observed. Participants reported high satisfaction, credibility, and expectations. One descriptive finding suggested a potential association between satisfaction and systolic blood pressure reduction, warranting further investigation. CONCLUSIONS: EMIRA is a complex intervention with an educational and musical component. The results suggest that a larger-scale clinical trial is feasible, participants were satisfied and had positive attitudes towards the intervention. Although no conclusions about its effectiveness can be drawn from this pilot study, the findings provide valuable information to guide the design of a larger randomized trial. TRIAL REGISTRATION: RBR-857nczs.