This study analyzed the feasibility and potential effectiveness of a CI for managing anxiety, physiological parameters and chest pain intensity in individuals with ACS awaiting unscheduled catheterization in the emergency department. The feasibility of conducting a RCT was assessed by through recruitment, retention, attrition rates, credibility, expectation and satisfaction.CI application to manage psycho-emotional symptoms in highly specialized services is still a challenge.(36, 37) However, comprehensive care intervention application, which consider all dimensions of individuals, has shown positive results.(38, 39)
Participant sociodemographic profile in this study was similar to a study carried out in Brazil in an emergency unit.(40) In the world population as well as in the present study a higher prevalence of males was also observed in individuals with ACS. (41–43)
Participants in this study had low education, with a predominance of elementary school. The literature shows an association between low socioeconomic status and low education with greater morbidity in cardiovascular diseases. (44, 45)
Regarding ACS clinical and electrocardiographic presentation, NSTEMI was the most observed in this study. In the literature, STEMI incidence is also higher, regardless of gender. In the United States, this type of acute myocardial infarction (AMI) accounts for 70% of ACS cases. (45–47) Retrospective, multicenter study compared male patients vs. female in terms of baseline characteristics, coronary findings and in-hospital and long-term prognosis and showed 79.9% of female patients with NSTEMI, while in males this number was 71.5% (p < 0.0001).(48)
This study included participants who had already experienced cardiac catheterization, i.e., a repeat procedure, and participants who were having this experience in an unprecedented way. The inclusion of these two participant profiles in the sample may have influenced EMIRA results. EMIRA may or may not be effective due to its effect on anxiety, or because the groups differed in relation to a potentially anxiogenic factor, the cardiac catheterization itself. A study whose objective was to determine whether there were differences in terms of anxiety and well-being between individuals undergoing percutaneous coronary intervention (PCI) for the first time and those undergoing repeat PCI showed no statistical difference between the two groups.(49)
The data suggests that conducting a larger-scale clinical trial to test the effectiveness of EMIRA is feasible. Recruitment and retention rates were high and attrition rate was low, and data collection time was less than two months. Other researchers have also investigated the feasibility of music interventions and educational interventions in other settings and found satisfactory responses.(50–52)
Regarding the estimated effectiveness of EMIRA in this pilot study, the IG showed a greater reduction in the anxiety score than the CG between T1 and T2 (-3 vs -3.7), but the difference between the groups was not significant. A significant decrease in the state anxiety score was observed in IG and CG between T1 and T3 (-5.9 vs -5.2, respectively). However, it is not possible to state that the effect of reducing state anxiety is attributed to EMIRA, as both groups showed an improvement in the outcomes analyzed at T3 after catheterization. As observed in other studies, it is possible that reduced state anxiety in both groups was caused by cardiac catheterization between T2 and T3.(20, 21)
Researchers assessed the effect of musical intervention on anxiety and stress responses in patients undergoing cardiac catheterization.(53) RCT that assessed the effectiveness of the musical intervention in terms of anxiety, cortisol level and HR variability showed evidence of a reduction in anxiety and stress response of the musical intervention preceding cardiac catheterization, indicating that this intervention should be considered. Anxiety was also assessed by STAI (F = 31.42, p < 0.001). (53)
Literature review showed different psychological preparation strategies and relaxation techniques that have been tested to reduce anxiety, stabilize physiological parameters and reduce pain intensity.(25) Education regarding the procedure was observed in 11 of the 29 studies analyzed and was effective in reducing anxiety.(25) Biofeedback, therapeutic touch and massage techniques also appeared to be effective in reducing anxiety, but not in reducing pain. (25)
A quasi-experimental study that assessed the effectiveness of a video-based educational intervention on anxiety levels in patients undergoing PCI showed that IG patients experienced a tendency towards reduced anxiety after PCI. (54) However, another RCT analyzed the effectiveness of an educational intervention using an informative manual in reducing anxiety, stress and changes in vital signs in patients awaiting cardiac catheterization and showed no impact on reducing anxiety and stress. (22)
A cohort that assessed patient characteristics associated with increased anxiety also showed a higher anxiety score before the procedure, in addition to the association with age < 65 years, being female, less education and undergoing primary PCI.(7) In line with these findings, a decrease in anxiety level after an invasive procedure was also observed in the present study.
In relation to vital signs (BP, HR and RR) and chest pain intensity to the effect of EMIRA, there was a difference in the means of diastolic BP, HR and RR over time in the two groups. The evidence available in systematic reviews of studies that assessed music to reduce anxiety in individuals undergoing cardiac catheterization was not conclusive in relation to vital signs and pain intensity. (20, 21)
Mean credibility and expectation scores were high, which suggests that participants believed that EMIRA would help reduce state anxiety. Assessing credibility and expectations is part of acceptability of the intervention by users. (55–57)
Credibility and expectation scores were similar between groups, which is encouraging, as participants believed that the intervention would bring results before cardiac catheterization. However, there was no significant correlation between credibility and expectations with outcome variables, suggesting that these variables probably did not influence the observed outcomes.
Sidani and Braden argue that participants must consider CI as acceptable and satisfactory and that this contributes to the effectiveness of the intervention.(55) The EMIRA satisfaction score was high, suggesting that IG participants considered the intervention satisfactory. Although satisfaction with the intervention may influence the analyzed outcomes, the only significant correlation observed occurred with SBP between T1 and T2.
This study has limitations that must be considered. The potentially noisy emergency department environment with limited privacy may have influenced anxiety level and EMIRA results. Measures to reduce this bias were implemented at the time of EMIRA’s applicability. Not having analyzed individuals’ prior knowledge regarding cardiac catheterization using a measuring instrument makes it difficult to establish the relationship between the effect of knowledge on reducing anxiety. Obtaining vital parameters through different multiparameter monitors was also considered a limitation. The devices undergo periodic maintenance and are analyzed by clinical engineering in terms of calibration. Furthermore, the interaction between patients and healthcare professionals during the procedure was not monitored. The effect of positive statements and medications within the catheterization room may have influenced the T3 results.