Virtual Reality for Anxiety Before Heart Catheterization

(VR-THEIA Trial)

Overseen By Ryan D Madder, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Spectrum Health Hospitals

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

180 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The primary aim of this study is to test the hypothesis that use of VR combined with standard procedural education will result in less pre-procedural anxiety than standard procedural education alone among patients undergoing first-time cardiac catheterization. The VR technology being evaluated in this study will allow patients to experience a 3-D simulation of certain aspects of their upcoming procedure prior to the actual procedure date.

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.

Is virtual reality safe for reducing anxiety in medical procedures?

Virtual reality has been used safely in various medical settings to help reduce anxiety, including in children undergoing chest radiography and adults during awake invasive procedures. Studies show it can decrease anxiety and improve patient satisfaction without significant safety concerns. ^{1 2 3 4 5}

How does the virtual reality treatment for anxiety before heart catheterization differ from other treatments?

The virtual reality treatment is unique because it provides an immersive experience that can reduce anxiety and improve understanding of the procedure, unlike traditional methods that may use generic videos or verbal explanations. This approach has been shown to enhance patient satisfaction and reduce anxiety more effectively than standard educational materials. ^{1 2 6 7 8}

What data supports the effectiveness of the treatment Virtual reality experience for anxiety before heart catheterization?

Research shows that virtual reality (VR) can help reduce anxiety and improve satisfaction in patients undergoing various medical procedures, including cardiac procedures and surgeries. VR has been found to provide a more enjoyable and informative experience, which can help manage anxiety and pain. ^{2 6 7 9 10}

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?

Spectrum Health Hospitals

Lead Sponsor

Trials

66

Recruited

553,000+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

The Effect of a VIrtual RealiTy Immersive Experience Upon Anxiety Levels, Procedural Understanding, and Satisfaction in Patients Undergoing CArdiac CaTHeterization: The VIRTUAL CATH Trial. [2021]

2. England 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. [2023]

3. United States 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. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Use of Virtual Reality to Distract From Pain and Anxiety. [2019]

5. England pubmed.ncbi.nlm.nih.gov

The Use of Virtual Reality to Reduce Preoperative Anxiety in First-Time Sternotomy Patients: A Randomized Controlled Pilot Trial. [2020]

6. Switzerland 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. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Virtual Reality Interventions for Needle-Related Procedural Pain, Fear and Anxiety-A Systematic Review and Meta-Analysis. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Can virtual reality enhance the patient experience during awake invasive procedures? A systematic review of randomized controlled trials. [2023]

9. Germany pubmed.ncbi.nlm.nih.gov

The effect of virtual reality distraction on reducing patients' anxiety before coronary angiography: a randomized clinical trial study. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Effectiveness of virtual reality in reducing preoperative anxiety in adults: A systematic review and meta-analysis. [2023]