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

Abstract

Background

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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.

Key messages regarding feasibility

• What uncertainties existed regarding the feasibility?

  Before this study, the feasibility of a complex intervention consisting of an educational and musical component in patients undergoing unscheduled cardiac catheterization in the emergency department was unknown.

• What are the key feasibility findings?

  EMIRA was a no-dropout intervention, with high recruitment and retention rates, short recruitment time and low attrition rate.

• What are the implications of the feasibility findings for the design of the main study?

  The results of this pilot study provide evidence that a larger randomized clinical trial testing EMIRA is feasible in the emergency department. Future studies should test the effectiveness and feasibility of EMIRA in other clinical units.

Background

Cardiac catheterization is the procedure of choice for risk stratification and treatment of acute coronary syndrome (ACS) [1, 2]. It is one of the most performed procedures in the world, with a risk of serious complications and mortality less than 1% [1, 3]. Although cardiac catheterization is routinely performed in specialized hospitals, it is often unknown to patients and can exacerbate symptoms of anxiety [3].

Anxiety related to cardiac catheterization (ARCC) can be defined as an unpleasant feeling of worry, concern and/or nervousness characterized as an adaptive phenomenon associated with cardiac catheterization, pain, hospitalization, fear, lack of knowledge or uncertainty [4]. This is a highly prevalent phenomenon in the perioperative period of cardiac catheterization [5,6,7]. In fact, ARCC incidence is highest in the 24 h preceding the procedure, affecting between 61% and 90% of patients awaiting the procedure [5,6,7]. ARCC has been associated with higher rates of complications both during the procedure and in the subsequent months [8,9,10,11,12,13,14,15,16]. Therefore, the preoperative period seems to be the ideal time to apply interventions aimed at managing ARCC [8,9,10,11,12,13,14,15,16].

Several non-pharmacological interventions have been tested for managing ARCC and other manifestations of anxiety, such as changes in vital parameters. Interventions with music and educational interventions, applied in isolation, are among the most studied as they are considered safe, cheap and easy to administe [17,18,19]. However, the literature on the effect of music and educational interventions on reducing ARCC, blood pressure (BP), heart rate (HR) and pain is controversial, which can be explained, in part, by the heterogeneity of interventions and low quality of published research reports [17, 20,21,22,23,24].

Lack of knowledge about the procedure is an anxiogenic factor widely recognized in the literature [12, 25,26,27]. In turn, the relaxing effects of music can alleviate feelings of tension and concern, which are characteristics of ARCC. The role of the musical component in the body is very complex. The human body’s response mechanisms to music can be attributed to mental schemes learned throughout life, mediated by sociocultural aspects, resulting in effects on mood, emotions, stress, and relaxation; the activation of neural circuits and specific neurological functions, being a stimulant of neural coherence; and the vibratory effects of music that occur at a cellular and genetic level, but are still poorly understood [28,29,30].

The combined and synergistic effect of complex interventions (CI) with a musical and educational component is still little explored in the literature [31]. As far as we know, this type of CI has not yet been tested in emergency departments. The primary objective of this study was to assess the feasibility of conducting a randomized clinical trial (RCT) to test the effectiveness of a CI called Education and Music Intervention to Reduce Anxiety (EMIRA) in an emergency unit. The secondary objectives were to estimate the potential effectiveness of EMIRA as well as patient credibility, expectations and satisfaction in relation to the intervention.

Methods

Study design, site, and period

This is a randomized, blind, pilot clinical trial. The study was carried out in the emergency unit of a public reference hospital for cardiopneumology in São Paulo, Brazil. Data collection was carried out from October 2021 to February 2022.

Population and inclusion and exclusion criteria

People with ACS awaiting unscheduled diagnostic or therapeutic catheterization were included. Unscheduled catheterization was defined in this study as a percutaneous procedure not scheduled on an outpatient basis and performed due to ACS diagnosis after individuals were admitted to the emergency unit.

Individuals aged 18 or older, literate, hemodynamically stable with or without the use of vasoactive medications, and those who were undergoing cardiac catheterization for the first time or more than a year ago were included. Individuals diagnosed with a psychiatric disorder and using mood modulators, whether prescribed or not, were not included. Individuals with hearing impairment that prevented them from listening to music within the established parameters, presented hemodynamic instability during data collection, whose therapeutic plan was modified and did not perform the procedure were excluded. We also excluded those whose musical component of the intervention was interrupted for any reason, because the interruption of this component would have been detrimental to the effect of the intervention on anxiety.

Sample size

The convenience sample for this study consisted of 40 participants who were randomized to the control group (CG) or intervention group (IG). As it is a pilot study, no sample size calculation was performed. As this is a feasibility pilot study, no formal sample size calculation was performed. The sample size of 40 participants was determined based on recommendations in the literature suggesting that feasibility studies commonly include 20 to 40 participants to identify potential issues in recruitment, retention, and intervention implementation [32, 33]. This number was considered sufficient to evaluate recruitment rates, protocol adherence, and preliminary variability of outcomes to inform the design of a future definitive trial.

Randomization and blinding

A random list of participants was generated by a statistical professional by randomly drawing 25 subjects from each group without replacement to generate the order in which they would appear in Excel^®. This list was delivered to an independent researcher, who prepared 50 opaque and sealed envelopes containing participants’ designation for CG or IG according to the study entry number. Upon accepting to participate in the study and according to the order of inclusion in the study, participants received a sequential number, and the envelope with the corresponding number was opened to find out the group in which they should be allocated.

It was not possible to blind the study participants, given the nature of the proposed intervention. The main researcher was blind to the randomization of participants and did not apply the intervention, nor did she collect data on clinical outcomes and satisfaction. Such data were collected and tabulated by a second independent researcher. The main researcher only had access to this data after the end of data collection. An interventionist, who was not involved with data collection or analysis, delivered both components of the intervention.

Interventions

Comparator

Individuals who agreed to participate responded to the initial assessment and were randomized. The CG received only conventional care, which consisted of medical and nursing actions. When cardiac catheterization was indicated, individuals were informed by the doctor about the procedure and its risks and benefits, and signed the consent to undergo examination. The nursing staff provided guidelines for preparing for the exam, such as the need for fasting and trichotomy. Anxiety assessment and management are not part of the routine perioperative care of cardiac catheterization in the service.

Intervention description

The IG received conventional care and EMIRA, a CI developed to reduce state anxiety, blood pressure (BP), heart rate (HR), respiratory rate (RR), and chest pain intensity in people awaiting catheterization for unscheduled cardiac arrest in the emergency unit. EMIRA has two therapeutic targets: lack of knowledge about the procedure and the unpleasant feeling of emotional discomfort, concern, or tension related to the procedure.

The interventionist delivered both components of the intervention in the emergency department. The educational component consisted of a 5- to 10-min session covering the following topics verbally: procedure purpose, exam preparation, physical sensations expected during catheterization, possible care, and complications after the procedure. In addition, a tablet was used to show a picture displaying the layout of the cath lab room and the equipment typically found in it. The musical component consisted of MusiCure^® 8 Peace [34], delivered before the cardiac catheterization in a single 20-min session, via headphones, at a volume between 60 and 70 dB, adjusted using an application called “Decibel X”

Data collection

For data collection, eligible individuals were identified through the institution’s electronic medical records, and their medical records were analyzed to verify the study inclusion criteria by the main researcher. All individuals who met the inclusion criteria and were in the emergency department during the data collection period were approached by the main researcher and invited to participate in the study. Those who agreed signed the informed consent form (ICF). The reasons for refusing to participate in the study, the reasons for withdrawing, the reasons for not approaching, and the time for recruiting the pilot study sample were collected. Data collection occurred at three moments: T1, before catheterization and offering EMIRA; T2, before catheterization and immediately after offering EMIRA; and T3, 2 to 4 h after catheterization. Figure 1 shows the data collection flowchart.

Fig. 1

Data collection flowchart. ICF, informed consent form; STAI, State-Trait Anxiety Inventory; VNRS, Visual Numeric Pain Scale; BP, blood pressure; RR, respiratory rate; HR, heart rate; EMIRA, Education and Music Intervention to Reduce Anxiety; IG, intervention group

Measures

Demographics and clinical data

At T1, demographic and clinical data were obtained through chart review or self-report. The sociodemographic and clinical data of interest were as follows: age; sex; weight; height; marital status; education; occupation; time elapsed since the onset of ACS symptoms; comorbidities; cardiovascular risk factors; medications in use, whether prescribed or not, prior to admission to the emergency department; Killip classification;[31] use of vasopressors at the time of data collection; performing angioplasty during the procedure; and type of percutaneous coronary intervention such as elective, primary, facilitated, or rescue.

Vital signs and chest pain intensity

Vital sign data were measured using verification devices available in the emergency department at T1, T2, and T3. All devices were properly calibrated. All vital sign checks were carried out with individuals in a supine position, on a stretcher, with a 30° inclination. Two consecutive measurements were always carried out, with a 1-min interval between them, and the mean of the two measurements was used for data analysis. Chest pain intensity was assessed using a Verbal Numerical Rating Scale (VNRS) ranging from 0 (absence of pain) to 10 (worst possible pain) [35].

Anxiety

Trait and state anxiety were assessed using the version of the State-Trait Anxiety Inventory (STAI) validated for use in Brazil at T1, T2, and T3 [36]. This instrument consists of two anxiety scales: trait and state. The state STAI requires participants to describe how they feel “right now” in relation to 20 items presented on a 4-point Likert scale, ranging from “absolutely not” to “very much”. Similarly, in the trait STAI, participants must answer “how they generally feel” in relation to 20 items on a 4-point Likert scale, ranging from “almost never” to “almost always”. To avoid response bias, some items are presented in reverse, and the scores must be reversed to calculate the score. The total score varies from 20 to 80 for each scale; the higher the score, the higher the level of anxiety.

Credibility and expectations

The Credibility and Expectation Scale regarding the intervention was used to assess the credibility and expectation regarding EMIRA at T1. This tool was developed by the authors of this study through the face and content validation process of the scale and contains four items assessing participant credibility and one item assessing expectations. The estimate of the face and content validity of the visual analogue scale of credibility and expectancy in relation to intervention was obtained through the opinion of five expert members (with at least 2 years of clinical experience in the care of individuals with ACS or in the management of symptoms in individuals with acute or chronic diseases) of two research groups from the School of Nursing of the University of São Paulo [37]. Each item is followed by a Likert-type scale ranging from 0 to 10. The final credibility score is given by the sum of the values recorded for the credibility items (ranging from 0 to 40), and the final expectation score is the value recorded for the expectation item (ranging from 0 to 10). The higher the score, the greater the credibility and the greater the positive expectation regarding EMIRA [38].

Participant satisfaction

IG participant satisfaction with EMIRA was assessed using a VNRS at T2. VNRS’s statement was “Considering that 1 is completely dissatisfied and 10 is completely satisfied, please state your satisfaction level with EMIRA”. The VNRS ranged from 1 (completely dissatisfied) to 10 (completely satisfied). The higher the score, the greater the satisfaction with EMIRA.

Data analysis

Sociodemographic and clinical characteristics

Welch’s T, Pearson, and Fisher’s exact tests were used to compare CG and IG in relation to sociodemographic and clinical characteristics at T1.

Viability

Feasibility was assessed through recruitment, retention, and attrition rates. The recruitment rate was determined by the ratio between the number of people who agreed to participate in the study and the number of potentially eligible people multiplied by 100, being considered satisfactory if greater than 60% [39]. The retention rate was calculated as the ratio of the number of people who completed the study and the number of people who started the study multiplied by 100, considered satisfactory if greater than 80% [39]. Finally, the attrition rate was determined by the ratio between the number of people who did not complete the study and the number of people who completed the study multiplied by 100, being considered satisfactory if it was less than 20% [39].

The reasons for refusing to participate in the study, reasons for withdrawing, and reasons for not approaching were recorded and analyzed using absolute and relative frequencies. Sample recruitment time was calculated by the number of days of data collection recorded in a field diary.

EMIRA effectiveness estimate

Descriptive analyses were conducted to summarize changes in anxiety, BP, HR, RR, and chest pain intensity across three time points (T1, T2, and T3) in both groups. Means and standard deviations (SD), along with 95% confidence intervals (CI), were used to describe outcome measures. No hypothesis testing was performed.

Credibility, expectations, and satisfaction

Credibility and expectation scores were summarized using means, standard deviations, and 95% confidence intervals. Descriptive comparisons between the control and intervention groups were explored to understand general trends. Participant satisfaction scores were described in the intervention group. Relationships between satisfaction, credibility, expectations, and outcome variables (STAI-state score, BP, HR, RR, and chest pain intensity) were explored descriptively, without formal statistical testing.

Ethical considerations

The study was approved by the Research Ethics Committees of the proposing (4.804.611) and co-participating (4.863.723) institutions. Participants were informed about their freedom to refuse/withdraw from the study. Data confidentiality and information confidentiality were ensured.

Results

All patients (n = 47) who met the inclusion criteria were approached, of which three refused to participate in the study, justifying tiredness, fear, and not having enough education to read and understand the ICF. Of those who agreed to participate in the study (n = 44), three were excluded due to changes in medical behavior, and one was excluded when collecting sociodemographic data because he reported using anxiolytics Daily. No participants were excluded due to hearing impairment, hemodynamic instability during data collection, or interruption during the delivery of the musical component. In the final sample, 40 participants remained. Randomization resulted in 22 participants in the CG and 18 in the IG, and Fig. 2 depicts the Consolidated Standards of Reporting Trials (CONSORT) flow diagram for the intervention and control groups [40].

There was no withdrawal from participation after participant inclusion and randomization. Participant sociodemographic and clinical characteristics are described in Table 1.

Fig. 2

Participant selection flowchart

Table 1 Participant sociodemographic and clinical characteristics

Table 1 presents the sociodemographic and clinical characteristics of participants in both groups. The distribution of most variables appeared similar between groups. However, diabetes was more frequently reported in the control group, while a greater proportion of individuals in the intervention group were undergoing cardiac catheterization for the first time.

Regarding drug treatment prior to emergency department admission, 15% of participants were not using any medications. Among those who reported prior pharmacological treatment, 70% were using antihypertensives, 47.5% used lipid-lowering agents, 40% used diuretics, and 27.5% used antidiabetic medication.

Viability

All eligible individuals (n = 47) were approached during the data collection period. It took 54 days to obtain a sample of 40 participants. No participant withdrew from participating in the study. Data related to the pilot clinical trial feasibility are described in Table 2.

Table 2 Recruitment, retention, and attrition rates and the number of refusals to participate in the pilot clinical trial

Efficacy estimation: assessment of clinical outcomes

The mean trait anxiety level was 47.14 ± 9.98 vs 41.22 ± 9.48 in the CG and IG, respectively.

Table 3 presents the descriptive analysis of state anxiety (STAI-State) scores over time in both groups. A decrease in anxiety scores was observed from T1 to T3 in both the control and intervention groups. While this downward trend suggests a potential improvement over time, no consistent difference between groups was observed. These findings are exploratory and should be interpreted with caution, as no formal hypothesis testing was conducted.

Table 3 Descriptive analysis of state anxiety scores over time in control and intervention groups

Table 4 presents the descriptive data on chest pain intensity in the control and intervention groups across time points. No consistent pattern or marked differences in pain scores were observed between the groups. The scores remained low at all time points in both groups, with slight fluctuations that do not suggest any observable trend. These findings are exploratory and intended to inform the design of future studies.

Table 4 Descriptive analysis of chest pain intensity over time in control and intervention groups

Table 5 summarizes descriptive data on vital signs (SBP, DBP, HR, and RR) at three time points for both the control and intervention groups. SBP values remained relatively stable over time in both groups, with no consistent differences observed. DBP, HR, and RR showed some variation across time points within both groups; however, these fluctuations did not follow a clear or consistent pattern. These findings are exploratory in nature and may inform outcome monitoring strategies in future studies.

Table 5 Descriptive analysis of vital signs over time in control and intervention groups

Credibility, expectations, and satisfaction

The mean credibility scores (CG = 36.4 ± 4.6 vs IG = 34.4 ± 6.3) and expectation (CG = 9.1 ± 1.3 vs IG = 8.6 ± 2 0.2) were high. Both groups were similar in terms of positive attitude towards the intervention. The mean satisfaction score in IG was 9.2 ± 1.1. No consistent patterns were observed between credibility or expectation scores and the outcome variables (STAI-State, SBP, DBP, HR, RR, and chest pain intensity) in the intervention group. However, a descriptive observation suggested that participants who reported higher satisfaction also tended to show a greater reduction in SBP from T1 to T2.

Discussion

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 an RCT was assessed through recruitment, retention, attrition rates, credibility, expectation, and satisfaction. CI application to manage psycho-emotional symptoms in highly specialized services is still a challenge [41, 42]. However, a comprehensive care intervention application, which considers all dimensions of individuals, has shown positive results [43, 44].

The participant sociodemographic profile in this study was similar to a study carried out in Brazil in an emergency unit [45]. In both the global population and the present study, a higher prevalence of males was also observed in individuals with ACS [46,47,48]. 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 [49, 50].

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 USA, this type of acute myocardial infarction (AMI) accounts for 70% of ACS cases [50,51,52]. A retrospective, multicenter study compared male patients vs. female patients in terms of baseline characteristics, coronary findings, and inhospital and long-term prognosis and showed that 79.9% of female patients had NSTEMI, while in males this number was 71.5% [53].

This study included participants who had already undergone cardiac catheterization, i.e., a repeat procedure, and participants who were experiencing this for the first time. 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 [54].

The results support the feasibility of conducting a larger-scale RCT testing EMIRA. Recruitment and retention rates were high, the attrition rate was low, and data collection time was less than 2 months. Other researchers have also investigated the feasibility of music interventions and educational interventions in other settings and found satisfactory responses [55,56,57].

Regarding potential effectiveness, descriptive data suggested a reduction in anxiety scores over time in both groups. However, since no hypothesis testing was conducted and both groups improved, these trends must be interpreted cautiously and cannot be attributed to the intervention. This is consistent with other studies indicating that anxiety levels tend to decrease following catheterization itself, rather than as a result of preprocedural interventions alone [20, 21].

Researchers assessed the effect of musical intervention on anxiety and stress responses in patients undergoing cardiac catheterization [58]. 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 [58]. Although anxiety was assessed using the STAI, the current study does not allow for statistical comparison; therefore, any similarities should be interpreted descriptively and not as evidence of effect size or significance [58].

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 [59]. 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.

Fluctuations in vital signs (BP, HR, and RR) and chest pain intensity were observed over time in both groups; however, no consistent or distinct trend emerged. These variations appear to be independent of the intervention and may be associated with the invasive nature of the procedure or contextual stressors. This interpretation is aligned with findings from systematic reviews, which concluded that evidence on the effectiveness of music interventions in altering physiological parameters and pain intensity during cardiac catheterization remains inconclusive [20, 21].

High mean credibility and expectation scores suggest that participants perceived EMIRA as a potentially beneficial strategy. These are important indicators of acceptability, and previous studies emphasize that perceived credibility and acceptability of an intervention are key factors influencing adherence and potential impact [60,61,62]. Although no statistical correlations were calculated, descriptive observations indicated that participants with higher satisfaction tended to show a reduction in systolic blood pressure after the intervention. This is preliminary and hypothesis-generating, not conclusive. Sidani and Braden argue that participants must consider CI as acceptable and satisfactory, and that this contributes to the effectiveness of the intervention [60]. The EMIRA satisfaction score was high, suggesting that IG participants considered the intervention satisfactory.

This study has limitations that must be considered. Despite measures to reduce the impact of ambient noise and lack of privacy implemented at the time EMIRA was delivered, the emergency department with increased acoustic load and limited privacy may have influenced anxiety levels and, possibly, the outcomes. Not having assessed individuals’ prior knowledge regarding cardiac catheterization, using a valid measurement tool makes it difficult to establish the relationship between the effect of knowledge on reducing anxiety. Obtaining vital signs through different multiparameter monitors may also be 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 T3 results.

Conclusions

EMIRA is a unique CI consisting of an educational component and a musical component, developed to alleviate anxiety in individuals awaiting cardiac catheterization in the emergency department. Recruitment, retention, and attrition rates suggest that conducting a larger-scale RCT to test the effect of EMIRA on state anxiety is feasible. However, the estimates observed in this pilot study do not permit any conclusions regarding the intervention’s impact on state anxiety, vital parameters (BP, HR, RR), and chest pain intensity. These analyses should be interpreted as exploratory and serve to inform the design of future studies.

EMIRA was considered satisfactory by participants, and further studies should investigate its effectiveness in reducing anxiety, vital parameters, and chest pain.