The Effect of a VIrtual RealiTy Immersive Experience Upon Anxiety Levels, Procedural Understanding, and Satisfaction in Patients Undergoing CArdiac CaTHeterization: The VIRTUAL CATH Trial

Objectives. In patients undergoing elective cardiac catheterization, we aimed to evaluate the use of an immersive virtual reality (VR) experience on periprocedural anxiety, procedural knowledge, and overall satisfaction, compared with using generic video-based material. Background. Cardiac catheterization is a commonly performed invasive investigation for patients with cardiovascular disease. Patients are understandably anxious, which can lead to negative psychological and physiological outcomes. It is known that informing patients adequately prior to their procedure improves the patient experience. Video-based material is used frequently in this setting with proven benefits. With the advancement of healthcare resources, the informed consent and explanation process could be further enhanced using VR technology. Methods. A randomized, controlled trial was conducted at a single tertiary center. Patients attending the preassessment clinic for elective cardiac catheterization were randomized to receive either standard care, or standard care + VR. Anxiety levels, procedural knowledge, and satisfaction were assessed before and after each procedure. Results. Sixty-four patients completed the trial (33 in the VR arm and 31 in the control arm). The VR group had a significantly greater reduction in anxiety level from baseline to post procedure than the control group (-5.1 vs -4.0, respectively; P=.03). In addition, the VR group had a better procedural understanding (3.88 vs 3.23, respectively; P<.01) and higher overall satisfaction than the control group (9.35 vs 8.97, respectively; P=.04). Conclusions. VR improved patient-centered outcomes for cardiac catheterization. This study highlights the importance of enhancing patient understanding for routine procedures. VR has been shown to improve holistic care in this patient population.

Key words: coronary angiography, healthcare technology, informed consent, patient satisfaction

Cardiac catheterization is an invasive investigation undertaken in patients with cardiovascular disease (CVD), which remains the leading cause of death in the United Kingdom (UK).¹ It is the gold-standard diagnostic test for coronary artery disease (CAD), providing important information in patients with valvular heart disease and left ventricular dysfunction. More than 250,000 cardiac catheterization procedures are performed each year in the UK, a number that is rising by 7% per year due to increased prevalence of CVD and advances in medical technology.²

Anxiety prior to invasive cardiac investigations is well recognized.³ It may be caused by lack of familiarity with hospital environment, concerns about the planned procedure, and multiple short encounters with different medical personnel.⁴ High levels of anxiety can negatively impact the patient experience and may lead to an increase in periprocedural pain as well as higher hospital readmission rates.^5,6 Furthermore, the physiological effects of anxiety (including tachycardia and vasoconstriction) may make cardiac catheterization more challenging for both the patient and the operator.⁷

The delivery of appropriate and accurate patient information prior to cardiac catheterization may help improve patient understanding and reduce anxiety.⁴ In particular, video-based patient information prior to cardiac catheterization has been shown to improve patient comfort and satisfaction as well as their tolerability of the procedure.^8,9 Video-based patient information has also been shown to reduce periprocedural heart rate and blood pressure.⁸ Delivery of detailed information, including procedure indication and associated risks, is also vital in ensuring sound informed consent, an area that is often associated with patient dissatisfaction and complaints if not broached appropriately.¹⁰ As a consequence, detailed video-based patient information on cardiac catheterization is readily available from the British Heart Foundation (BHF). This information is used routinely within the preprocedural preparation of patients undergoing cardiac catheterization within our hospital.

Novel technologies are increasingly being seen in healthcare environments, including the use of virtual reality (VR).¹¹ VR has been used in surgical specialties and oncology services to better prepare patients for their upcoming treatment.^12-14 It has also been shown to reduce patient anxiety and improve overall experience in the cardiovascular field.¹⁵ The inviting nature of VR allows patients to truly immerse themselves within the environment in which they will be treated. We propose that VR will be a beneficial adjunct in the preparation of patients for cardiac catheterization. To date, the use of VR to prepare patients for cardiac catheterization has not been studied.

We developed an immersive VR video, unique to the experience of patients undergoing cardiac catheterization at our hospital. Our primary objective was to assess whether the use of an immersive and site-specific VR experience decreases periprocedural anxiety in patients undergoing cardiac catheterization, as compared with watching generic video-based material. Our secondary objectives were to assess whether exposure to the VR video improved patient knowledge of their procedure and overall satisfaction.

A single-center, randomized, controlled trial was carried out in patients undergoing cardiac catheterization at our tertiary center. All patients undergoing their first cardiac catheterization were eligible to enter the study. Exclusion criteria included: (1) an inability to comprehend the English language (as the VR video was only available in English); and (2) significant visual or auditory impairment, which may impair the patient’s ability to fully comprehend the VR video material. Patients were recruited from the preassessment clinic, which they attended 1 week prior to their planned cardiac catheterization procedure.

Trial protocol. The study protocol is presented in Figure 1. Patients were recruited and consented was obtained; they then completed a baseline questionnaire (Appendix 1A). Patients were then randomized to standard preprocedural care (information provided included BHF information booklets, verbal explanation of the procedure by the preprocedural assessment nurse, and then opportunity to watch the BHF cardiac catheterization video) or preprocedural care with immersive VR experience (information provided included BHF information booklets, verbal explanation of the procedure by the preprocedural assessment nurse, and then opportunity to watch the locally produced VR immersive video on a dedicated VR headset). Patients in the VR group watched a 10-minute VR video describing the preprocedural and procedural experience for the day of their cardiac catheterization. Concurrent audio was provided through earplugs to complete the patient’s immersive experience.

The video was written and directed by the research team, and care was taken to ensure that the same procedural information was contained within both the BHF cardiac catheterization video and the VR immersive video. Filming was performed within the cardiac catheterization laboratories at our hospital using the professional services of Orchard Media. We utilized physicians and nurses to re-enact a typical day for a mock patient undergoing an uncomplicated procedure (Figure 2), alongside a short procedural explanation including animations to explain technical aspects. Preprocedural (Appendix 1B) and postprocedural anxiety questionnaires (Appendix 1C), as well as a satisfaction questionnaire (Appendix 1D) were then completed when the patient attended their procedure.

Primary outcome measure. The primary outcome measure was periprocedural anxiety level. Data collection was via questionnaire based upon the validated 6-item short form of the State Trait Anxiety Inventory (STAI), a well-established and validated measure of anxiety.¹⁶ The STAI has been validated as a measure of anxiety in patients undergoing invasive procedures.^12,17,18

Statistical analysis. A power calculation determined that a total of 80 patients was required, with 40 in each group (assumed reduction of 2 points between VR and control, standard deviation of 4, coefficient correlation of 0.73, power of 0.9, type I error rate at 0.05). To allow for those lost to follow-up, the intended study population comprised 100 patients. Results are presented as absolute numbers, percentages, and means. Anxiety and understanding scores were calculated by assigning a value to the chosen level of agreement with a statement (Appendix 2). Data were analyzed on SPSS software (2009; IBM) using appropriate statistical tests, including analysis of covariance (ANCOVA), Mann-Whitney, and Chi square. A P-value of <.05 was considered significant.

Research ethics committee approval was gained prior to study commencement (Wales REC 6; REC reference, 19/WA/0063; clinicaltrials.gov identifier NCT03957538).

There were 87 patients recruited into the trial between August 2019 and February 2020. The trial was terminated prematurely due to service changes related to the COVID-19 pandemic. In total, 64 patients completed the trial protocol and were included in the analysis. Of these, 33 were randomized to the intervention (VR) arm, and 31 to the control arm.

Demographics. The mean age of participants was 68.7 years (range, 38-84 years). In terms of gender, 27/64 (42%) were women and 37/64 (58%) were men. In total, 19/64 (30%) reported having friends or family who had previously undergone coronary catheterization. When asked how they would seek further information about the procedure if desired, 42 participants reported they would wait until they visited the hospital to seek further information, 20 stated they would ask their general practitioner, 10 stated they would ask friends, and 14 reported that they would search on the internet (participants could select multiple answers).

Baseline questionnaire results. Overall mean baseline anxiety score was 13.6/28 (range, 7-23; median, 14). There were no significant differences in baseline anxiety scores between the 2 groups, with a mean score of 13.5 in the VR group and 13.6 in the control group (P=.90). Participants were asked if they understood why they were having an angiogram, overall mean understanding was 3.45/4, with no significant difference between the 2 groups (3.6 in the VR group vs 3.3 in the control group; P=.13) (Table 1).

Preprocedure questionnaire results. Overall mean anxiety score was 12.5/28. There was a trend toward reduced anxiety in the VR group, with a score of 11.9 vs 13.1 for the control group (median score, 11 vs 14, respectively; P=.28) (Table 1). The change in anxiety between baseline and pre procedure was -1.61 in the VR group vs -0.48 in the control group (P=.11 by ANCOVA).

We tested the participants’ understanding of the rationale for catheterization in the preprocedural questionnaire. The mean understanding score was 3.85/4 in the VR group vs 3.48/4 in the control group. The change between baseline and preprocedure understanding was +0.23 in the VR group vs +0.21 in the control group (P=.18 by ANCOVA).

Postprocedure questionnaire results. Overall mean postprocedure anxiety score was 9.0/28. It was significantly lower in the VR group vs the control group (8.5 vs 9.7, respectively; P=.048; median score, 9 vs 10, respectively) (Table 1 and Figure 3). The overall reduction in periprocedural anxiety levels (baseline to postprocedure change) was significantly greater in the VR group vs the control group (-5.1 vs -4.0, respectively; P=.03 by ANCOVA).

Participants were asked to rate their agreement with the following 3 statements, scoring each out of 4:

1. “I understand how the angiogram was done.” The VR group subjectively reported a better understanding of the procedure than the control group (3.88 vs 3.23, respectively; P<.01).

2. “I felt anxious during the angiogram.” There was a trend toward less anxiety in the VR group than in the control group, consistent with the formal anxiety assessment (1.97 vs 2.26, respectively; P=.15)

3. “I felt I had enough information about the angiogram.” This response scored higher in the VR group than in the control group (3.88 vs 3.65, respectively; P=.21).

Overall participant satisfaction. Participants were asked to rate a series of statements from 0-10. Mean scores and significance are shown in Table 2. The difference in rated comfort of the test as well as overall satisfaction were both statistically significantly higher in the VR group vs the control group (P=.03 and P=.04, respectively).

Participants were asked if they would be willing to undergo the test again, and 87% of the control group and 97% of the VR group stated yes (P=.14 by Chi square test).

This is the first study to evaluate the use of a VR immersive video prior to coronary catheterization. Periprocedural anxiety levels, procedural understanding, and overall satisfaction were improved using this technology, and results were superior to our standard-care arm that used generic, non-VR video-based information. These findings are in keeping with other work that has shown that VR improves the quality of communication and understanding before surgical procedures.¹⁹ The VR experience was immersive and specific, which allows patients to have a “sense of presence” in the proposed environment, improving familiarity and decreasing anxiety.²⁰

Anxiety. In our patient cohort, we saw a trend toward reduced anxiety in participants who undertook the immersive VR experience when they completed their preprocedural questionnaire on the day of the procedure as well as post procedure. This would suggest that the immersive nature of the VR video had better prepared these patients for the catheterization laboratory environment and the procedure itself. This is important, given the previously discussed deleterious consequences of anxiety.^6,7,21 Higher anxiety levels have been associated with increased vascular inflammation, endothelial dysfunction, and reduced parasympathetic activity.²² Reduced periprocedural anxiety also renders patients better able to process and store information, allowing the patient to have better autonomy.²³ This is clinically relevant, as patients may be presented with results and further management options immediately post procedure. The effect of VR upon periprocedural anxiety levels has been explored in other settings; VR reduced perioperative stress levels in patients undergoing cranial and spinal surgery.¹² It has significant benefits, such as allowing the patients to place themselves within the hospital environment and familiarize themselves with the likely interactions with healthcare professionals.¹² Individualized information has also been shown to have a greater reduction on anxiety levels than generic resources.¹⁸

Understanding. When examining patient understanding of the procedure and its indications, at baseline there was no significant difference in the knowledge demonstrated by participants in either group. We asked patients how they would source further information about the upcoming procedure; 66% of the patients stated that they would wait to ask questions at their next hospital visit. This highlights the need to disseminate articulate, accurate, and easily digestible patient-centered information to each patient when they attend preprocedural appointments, as they may not seek further information. Inadequate understanding can lead to increased preprocedural anxiety, which clearly also has ramifications on informed consent. Poor communication and inadequate informed consent contribute to a large proportion of patient complaints in all healthcare systems.¹⁰ Low literacy levels are also common in our patient population, which has been shown to be associated with reduced information-seeking behavior and reduced benefit from written information.²⁴

We found that patients who undertook the immersive VR video felt they had a significantly better understanding of the catheterization procedure than patients who received standard preprocedural care. In general, patients within the VR group were more likely to feel that they had received adequate information about the angiogram procedure. Improved patient understanding is paramount to shared decision making and has been demonstrated to improve patient outcomes and patient experience.²⁴ It must be considered that the study did not reach adequate power due to premature cessation. It is possible that these trends might have reached statistical significance if the trial had completed as originally planned.

Satisfaction. Encouragingly, patients who experienced the immersive VR video reported improved satisfaction with their procedure compared with those in the control group. This finding is consistent with previously published work; in a study of patients undergoing cranial and spinal operations, higher levels of satisfaction were reported by those who were exposed to a preoperative immersive VR experience.¹² The authors hypothesized that by improving their understanding of the procedure, patient uncertainty (and therefore anxiety) would be reduced, resulting in improved satisfaction. Supporting this hypothesis, we found that our patients had an improved understanding of the coronary angiogram procedure in addition to improved satisfaction. Additionally, although not significant, 97% of the VR group compared with 87% of the control group reported they would be happy to undergo the procedure again. This is important, because patients with complex revascularization anatomy may require multiple procedures.

Study limitations. The trial was terminated prematurely as a consequence of the COVID-19 pandemic; therefore, the number of patients recruited to the study was less than anticipated. The use of a questionnaire invariably introduces response bias, but this method was considered to be the most appropriate tool for measuring outcomes in this trial. The use of patient-reported outcome measures is paramount in developing services that deliver holistic patient-centered care, but can be difficult to measure. By using a validated tool, we aimed to provide the most accurate reflection of patient experience possible.

Patients in our center gained benefit from the use of immersive VR prior to cardiac catheterization in terms of reduced anxiety, improved understanding of the procedure, and satisfaction when compared with generic video-based information. The results of the study show promise in terms of this new technology and its potential to improve our ability to deliver patient-centered care.