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Behavioural Intervention
Virtual Reality Therapy for Inflammatory Bowel Disease
N/A
Recruiting
Led By Shirley Cohen-Mekelburg, MD, MS
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Patients with an uncontrolled cardiac condition such as an arrhythmia, coronary artery disease, or neurological/cerebrovascular disease
Patients that have previously had a seizure, loss of awareness, or other symptoms linked to an epileptic condition
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 week (semi-structured interview within 1 week of completion of the intervention)
Awards & highlights
No Placebo-Only Group
Summary
This trial is investigating the use of virtual reality therapy for patients with inflammatory bowel disease who are in the hospital. The goal is to see if this type of therapy is feasible and well-received for managing
Who is the study for?
This trial is for hospitalized patients with Inflammatory Bowel Disease (IBD) who are interested in trying a new pain treatment. The study will test if a Virtual Reality (VR)-directed therapy can help manage their pain while they're in the hospital.
What is being tested?
The intervention being studied is a VR-directed brain-gut behavioral therapy (BGBT). It's designed to see if using VR technology can be an effective way to treat pain for IBD patients during their hospital stay.
What are the potential side effects?
Since this trial involves non-invasive virtual reality therapy, there may not be typical medication side effects. However, participants might experience discomfort from wearing the VR headset or motion sickness.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have uncontrolled heart or brain conditions.
Select...
I have had seizures or episodes of losing awareness before.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 week (semi-structured interview within 1 week of completion of the intervention)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 week (semi-structured interview within 1 week of completion of the intervention)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Acceptability using the System Usability Scale - patients
Acceptability using the Treatment Acceptance and Adherence Scale- patients
Intervention acceptability based on qualitative data and collected from audio-recordings of semi-structured interview
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Virtual reality-directed BGBTExperimental Treatment1 Intervention
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Who is running the clinical trial?
University of MichiganLead Sponsor
1,852 Previous Clinical Trials
6,432,702 Total Patients Enrolled
Shirley Cohen-Mekelburg, MD, MSPrincipal InvestigatorUniversity of Michigan
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