Letícia de Carvalho Batista, Marina de Góes Salvetti, Milena Santos de Oliveira, Juliana Paulucci Reis, Youri Eliphas de Almeida, Rafael de Jesus Fonseca, Rita de Cassia Gengo E Silva Butcher
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引用次数: 0
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. 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.
期刊介绍：
Pilot and Feasibility Studies encompasses all aspects of the design, conduct and reporting of pilot and feasibility studies in biomedicine. The journal publishes research articles that are intended to directly influence future clinical trials or large scale observational studies, as well as protocols, commentaries and methodology articles. The journal also ensures that the results of all well-conducted, peer-reviewed, pilot and feasibility studies are published, regardless of outcome or significance of findings. Pilot and feasibility studies are increasingly conducted prior to a full randomized controlled trial. However, these studies often lack clear objectives, many remain unpublished, and there is confusion over the meanings of the words “pilot” and “feasibility”. Pilot and Feasibility Studies provides a forum for discussion around this key aspect of the scientific process, and seeks to ensure that these studies are published, so as to complete the publication thread for clinical research.
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