180 Participants Needed

Virtual Reality for Anxiety Before Heart Catheterization

(VR-THEIA Trial)

SM
RD
Overseen ByRyan D Madder, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Spectrum Health Hospitals
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 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.12345

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.16789

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.124610

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.

Eligibility Criteria

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.
See 2 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: TreatmentExperimental Treatment1 Intervention
Standard pre-procedural education plus virtual reality experience for cardiac catheterization.
Group II: ControlActive Control1 Intervention
Standard pre-procedural education for cardiac catheterization.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Spectrum Health Hospitals

Lead Sponsor

Trials
66
Recruited
553,000+

Findings from Research

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.
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.
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.
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]

References

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]
Effectiveness of virtual reality on anxiety and pain management in patients undergoing cardiac procedures: a protocol for systematic review and meta-analysis. [2023]
Effects of Preoperative Virtual Reality Magnetic Resonance Imaging on Preoperative Anxiety in Patients Undergoing Arthroscopic Knee Surgery: A Randomized Controlled Study. [2020]
Use of Virtual Reality to Distract From Pain and Anxiety. [2019]
The Use of Virtual Reality to Reduce Preoperative Anxiety in First-Time Sternotomy Patients: A Randomized Controlled Pilot Trial. [2020]
Virtual Reality vs. Tablet Video as an Experiential Education Platform for Pediatric Patients Undergoing Chest Radiography: A Randomized Clinical Trial. [2021]
Virtual Reality Interventions for Needle-Related Procedural Pain, Fear and Anxiety-A Systematic Review and Meta-Analysis. [2021]
Can virtual reality enhance the patient experience during awake invasive procedures? A systematic review of randomized controlled trials. [2023]
The effect of virtual reality distraction on reducing patients' anxiety before coronary angiography: a randomized clinical trial study. [2021]
Effectiveness of virtual reality in reducing preoperative anxiety in adults: A systematic review and meta-analysis. [2023]
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