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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
Must not have
History of seizures, migraine headaches, or severe susceptibility to motion sickness
Currently taking psychotropic drugs or on long-term psychotropic treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up procedure day
Awards & highlights
No Placebo-Only Group
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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 75 years old.
Select...
I am scheduled for a left-heart catheterization at the Meijer Heart Center.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of seizures, migraines, or severe motion sickness.
Select...
I am currently on long-term medication for mental health.
Select...
I cannot read or speak English.
Select...
I have had heart procedures done in a cath lab.
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.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Anxiety Measured by the STAI
Secondary study objectives
Sense of Preparedness evaluated by site survey
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
~140
Find a Location
Who is running the clinical trial?
Spectrum Health HospitalsLead Sponsor
65 Previous Clinical Trials
552,901 Total Patients Enrolled
1 Trials studying Anxiety
49 Patients Enrolled for Anxiety
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of seizures, migraines, or severe motion sickness.I am currently on long-term medication for mental health.I am between 18 and 75 years old.I cannot read or speak English.I am scheduled for a left-heart catheterization at the Meijer Heart Center.I have had heart procedures done in a cath lab.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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