Virtual Reality (VR) -Directed Brain Gut Behavioral Treatment (BGBT) for Inflammatory Bowel Disease (IBD) Inpatients

Inflammatory Bowel Diseases Clinical Trial

Official title:

Evaluation of a Virtual Reality-Directed Brain Gut Behavioral Treatment Inpatient Program for Patients With Inflammatory Bowel Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06188793
• Other study ID #: HUM00240999
• Status: Recruiting
• Phase: N/A
• Start date: February 13, 2024
• Est. completion date: July 2025

Study information

• Verified date: February 2024
• Source: University of Michigan
• Contact: Shirley Cohen-Mekelburg, MD, MS
• Phone: 734-845-5735
• Email: shcohen[@]med.umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The research is studying virtual reality (VR)-directed brain-gut behavioral therapy (BGBT) as a pain treatment option for hospitalized patients with inflammatory bowel disease (IBD). This study is being done to learn if VR-directed BGBT is feasible and acceptable for patients with IBD in addressing pain in the hospital setting. The study hypothesizes that: - At least 75% of enrolled participants will complete the VR-directed BGBT inpatient program - Hospitalized patients with IBD will find VR-directed BGBT acceptable as a pain treatment option in the inpatient setting.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with Inflammatory Bowel Disease and self-reported pain
• Hospitalized for management of IBD (inpatient medicine services at Michigan Medicine)

Exclusion Criteria:

• Patients that do not report pain
• Anticipated length of hospital stay is less than 72 hours
• Patients that have previously had a seizure, loss of awareness, or other symptoms linked to an epileptic condition
• Patients with binocular vision loss
• Patients with an uncontrolled cardiac condition such as an arrhythmia, coronary artery disease, or neurological/cerebrovascular disease.
• Patients that are currently pregnant

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Device:
• Virtual reality-directed BGBT
Enrolled participants will receive up to 3-days of VR-directed BGBT through several modules including distraction games, mindfulness meditation, breathing exercises, and cognitive behavioral therapy based coaching. Participants will complete questionnaires at various time points and be asked to complete a semi-structured interview post-intervention.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of the intervention measured as the frequency (percentage) of enrolled participants that complete the VR-directed BGBT inpatient program		3 days of treatment
Secondary	Intervention acceptability based on qualitative data and collected from audio-recordings of semi-structured interview	Patient acceptability will be evaluated through semi-structured interviews within 1 week of completion of the intervention to understand satisfaction, expectations, and experiences with the protocol, including perceived benefits or harms, and barriers to use.	1 week (semi-structured interview within 1 week of completion of the intervention)
Secondary	Acceptability using the System Usability Scale - patients	This is a 10-item question scale that are answered from a range from strongly agree to strongly disagree. Scores range from 0 to 100 with a higher score indicating greater acceptability.	Day 3 (post intervention)
Secondary	Acceptability using the Treatment Acceptance and Adherence Scale- patients	This is a 10-item question scale that have a range from disagree strongly- agree strongly.; Scores range from 10-70 with higher scores indication greater acceptability.	Day 3 (post intervention)