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Virtual Reality for Anxiety Before Heart Catheterization (VR-THEIA Trial)

N/A

Waitlist Available

Research Sponsored by Spectrum Health Hospitals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged between 18 and 75 years

Scheduled to undergo a left-heart catheterization procedure at the Meijer Heart Center

Timeline

Screening 3 weeks

Treatment Varies

Follow Up procedure day

Awards & highlights

VR-THEIA Trial Summary

This trialtests if using VR tech plus education can reduce pre-procedure anxiety in first-time cardiac catheterization patients, by showing them a 3-D simulation of their procedure.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While VR is generally safe, it may cause side effects like temporary discomfort, dizziness or nausea especially in those prone to motion sickness. There's also a small risk of triggering seizures in susceptible individuals.

VR-THEIA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 75 years old.

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

VR-THEIA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline visit to procedure day. baseline visits will occur up to 4 weeks prior to procedure.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline visit to procedure day. baseline visits will occur up to 4 weeks prior to procedure.

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline visit to procedure day. baseline visits will occur up to 4 weeks prior to procedure. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Anxiety Measured by the STAI

Secondary outcome measures

Sense of Preparedness evaluated by site survey

VR-THEIA Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Virtual reality experience

2019

N/A

~60

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Spectrum Health HospitalsLead Sponsor

64 Previous Clinical Trials

553,029 Total Patients Enrolled

1 Trials studying Anxiety

49 Patients Enrolled for Anxiety

Media Library

Virtual reality experience Clinical Trial Eligibility Overview. Trial Name: NCT03662607 — N/A

Anxiety Research Study Groups: Control, Treatment

Anxiety Clinical Trial 2023: Virtual reality experience Highlights & Side Effects. Trial Name: NCT03662607 — N/A

Virtual reality experience 2023 Treatment Timeline for Medical Study. Trial Name: NCT03662607 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria must participants satisfy to be eligible for this clinical trial?

"To qualify for this clinical trial, prospective participants must have an anxiety disorder and be between 18-75 years of age. 180 individuals are being sought to take part in the experiment."

Answered by AI

Does this research endeavor encompass individuals over 80 years old?

"This clinical trial is recruiting people who have reached the age of consent and are under the ripe old age of 75."

Answered by AI

Are individuals being enrolled in this experimental program presently?

"According to clinicaltrials.gov, there is no current recruitment for this trial that was initially posted on April 18th 2017 and last modified on November 22nd 2022. Nevertheless, 416 other studies are presently looking for participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Impact of Virtual Reality on Pre-procedural anxieTy Prior to Heart cathEterIzAtion - VR-THEIA

Ryan Madder, MD 2017. "Impact of Virtual Reality on Pre-procedural anxieTy Prior to Heart cathEterIzAtion - VR-THEIA". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03662607.

All > Generalized Anxiety Disorder > Anxiety