Virtual Reality for Anxiety Before Heart Catheterization

(VR-THEIA Trial)

Overseen By Ryan D Madder, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Corewell Health West

Must not be taking: Psychotropic drugs

Disqualifiers: Cardiac procedures, Seizures, Migraines, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if virtual reality (VR) can reduce anxiety for individuals about to undergo their first heart catheterization, a procedure to assess heart health. Participants will receive either standard education about the procedure or a VR experience beforehand. This trial suits those who have never had a heart procedure and are scheduled for catheterization at the Meijer Heart Center. Participants should not have a history of seizures, migraines, or severe motion sickness. As an unphased trial, this study provides a unique opportunity to explore innovative methods to ease anxiety before heart procedures.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are currently taking psychotropic drugs (medications affecting mood, perception, or behavior), you would not be eligible to participate.

What prior data suggests that this virtual reality experience is safe for patients undergoing cardiac catheterization?

Research has shown that virtual reality (VR) is generally safe and easy to use. Studies have demonstrated that VR can reduce anxiety in patients before medical procedures, yielding promising results with few side effects. For example, one study found that using VR to prepare patients for heart procedures lowered anxiety more effectively than standard information alone.

Another study explored VR for stress relief and found it to be a low-risk way to reduce stress. Overall, these findings suggest that VR is a safe option for easing anxiety before procedures like heart catheterization. No major negative effects were reported in these studies, which is reassuring for anyone considering participation in a trial using VR. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using virtual reality (VR) for anxiety before heart catheterization because it offers a unique, immersive experience that can help calm patients in a way traditional methods might not. Unlike standard pre-procedural education, which relies on verbal and written information, VR provides a visual and interactive method of preparation, potentially reducing anxiety more effectively. This innovative approach could lead to a more relaxed patient experience, making procedures smoother and less stressful.

What evidence suggests that this virtual reality experience is effective for reducing anxiety before heart catheterization?

Research has shown that virtual reality (VR) can help reduce anxiety before medical procedures. In this trial, participants in the treatment arm will receive standard pre-procedural education plus a virtual reality experience for cardiac catheterization. One study found that patients who used VR felt much less anxious compared to those who received standard care. Another study demonstrated that VR therapy significantly lowered anxiety levels before heart procedures. Additionally, VR proved more effective than standard care at calming patients during coronary angiography, a heart procedure. These findings suggest that VR could help ease anxiety in patients undergoing heart catheterizations. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 who are about to have their first heart catheterization at the Meijer Heart Center. They must be able to read and speak English, provide written consent, and not have a history of seizures, migraines or severe motion sickness. Those on psychotropic drugs or with past cardiac procedures can't join.

Inclusion Criteria

I am scheduled for a left-heart catheterization at the Meijer Heart Center.

Signed study consent form

Exclusion Criteria

I have a history of seizures, migraines, or severe motion sickness.

I am currently on long-term medication for mental health.

I have had heart procedures done in a cath lab.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Pre-procedural Education

Participants receive standard pre-procedural education, with the experimental group also experiencing a VR simulation

Up to 4 weeks

1 visit (in-person)

Procedure Day

Participants undergo cardiac catheterization

1 day

1 visit (in-person)

Follow-up

Participants are monitored for anxiety and preparedness outcomes

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Virtual reality experience

Trial Overview

The study tests if using Virtual Reality (VR) along with standard education before a heart catheterization can reduce anxiety more than just the standard education alone. Participants will experience a simulated version of their procedure in VR prior to the actual date.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

Standard pre-procedural education plus virtual reality experience for cardiac catheterization.

Group II: Control Active Control 1 Intervention

Standard pre-procedural education for cardiac catheterization.

Who Is Running the Clinical Trial?

Corewell Health West

Lead Sponsor

Spectrum Health Hospitals

Lead Sponsor

Trials

66

Recruited

553,000+

Published Research Related to This Trial

Patients who experienced a preoperative virtual reality (VR) session with 3D MRI models of their knee reported significantly lower anxiety levels compared to those who received standard information, as measured by the Amsterdam Preoperative Anxiety and Information Scale.

The VR group also showed higher satisfaction and lower stress levels postoperatively, indicating that VR can enhance the overall patient experience before and after arthroscopic knee surgery, although it did not impact pain or preparedness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Preoperative Virtual Reality Magnetic Resonance Imaging on Preoperative Anxiety in Patients Undergoing Arthroscopic Knee Surgery: A Randomized Controlled Study. Yang, JH., Ryu, JJ., Nam, E., et al.[2020]

In a randomized controlled trial involving 20 first-time sternotomy patients, immersive virtual reality (VR) treatment significantly reduced anxiety levels compared to a tablet-based control, with VR users reporting feeling calmer and less tense (P<0.05).

The study demonstrates that VR is an effective nonpharmacologic method for alleviating preoperative anxiety in adults undergoing cardiac surgery, highlighting its potential utility in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Virtual Reality to Reduce Preoperative Anxiety in First-Time Sternotomy Patients: A Randomized Controlled Pilot Trial. Hendricks, TM., Gutierrez, CN., Stulak, JM., et al.[2020]

In a study of 120 children aged 4 to 8 undergoing chest radiography, those using virtual reality (VR) experienced significantly less anxiety, with 81.7% showing low distress compared to 53.3% in the standard video group.

The VR group not only had lower anxiety scores but also required less parental presence and had shorter procedure times, indicating that VR can enhance the efficiency of medical procedures for pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality vs. Tablet Video as an Experiential Education Platform for Pediatric Patients Undergoing Chest Radiography: A Randomized Clinical Trial. Ryu, JH., Park, JW., Choi, SI., et al.[2021]

This systematic review and meta-analysis aims to evaluate the effectiveness of virtual reality (VR) technology in reducing anxiety and pain during cardiac procedures, comparing it to standard care, based on randomized controlled trials (RCTs).

Previous studies suggest that VR can enhance patient experiences by improving understanding of procedures and potentially leading to better outcomes, making it a promising tool for managing anxiety and pain in cardiac settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of virtual reality on anxiety and pain management in patients undergoing cardiac procedures: a protocol for systematic review and meta-analysis. Bashir, Z., Misquith, C., Has, P., et al.[2023]

A systematic review of 11 randomized controlled trials involving 892 adult patients found that virtual reality (VR) interventions significantly reduce preoperative anxiety, with VR exposure being particularly effective.

In addition to lowering anxiety, VR interventions also effectively reduced heart rate and blood pressure compared to traditional methods, although they did not significantly impact respiration rate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of virtual reality in reducing preoperative anxiety in adults: A systematic review and meta-analysis. Gao, Y., Wang, N., Liu, N.[2023]

Virtual reality (VR) significantly reduces pain in pediatric patients undergoing needle-related procedures, with a meta-analysis of 3204 patients showing a mean difference of -2.85 on the Wong-Baker Faces Pain Rating Scale.

While VR was effective in decreasing pain, it did not show significant improvements in fear, anxiety, or satisfaction scores, indicating that more research is needed to fully understand its impact in these areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality Interventions for Needle-Related Procedural Pain, Fear and Anxiety-A Systematic Review and Meta-Analysis. Czech, O., Wrzeciono, A., Rutkowska, A., et al.[2021]

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