Affiliation:
1. USP EE: Universidade de Sao Paulo Escola de Enfermagem
2. Universidade Federal de São Paulo: Universidade Federal de Sao Paulo
3. ICON Clinical Research
4. Hospital Israelita Albert Einstein: Sociedade Beneficente Israelita Brasileira Albert Einstein
5. Universidade de Sao Paulo
6. FAU: Florida Atlantic University
Abstract
Abstract
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. The significance level adopted was 5%.
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 participant withdrew from continuing in the study after recruitment. No significant difference was observed between CG and IG in relation to the analyzed outcomes. The mean score for satisfaction, credibility and expectations were high. There was a negative correlation between satisfaction and the difference in SBP between T1 and T2.
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. However, EMIRA did not promote a significant change in the outcomes analyzed.
Trial registration
RBR-857nczs
Publisher
Research Square Platform LLC
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