NCT06188793

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 3, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

February 13, 2024

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

2.2 years

First QC Date

December 18, 2023

Last Update Submit

January 27, 2026

Conditions

Inflammatory Bowel Diseases

Keywords

Virtual realityInpatientPainBrain Gut Behavioral Treatment

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Intervention acceptability based on qualitative data and collected from audio-recordings of semi-structured interview

    1 week (semi-structured interview within 1 week of completion of the intervention)

  • Acceptability using the System Usability Scale - patients

    Day 3 (post intervention)

  • Acceptability using the Treatment Acceptance and Adherence Scale- patients

    Day 3 (post intervention)

Study Arms (1)

Virtual reality-directed BGBT

EXPERIMENTAL
Device: Virtual reality-directed BGBT

Interventions

Virtual reality-directed BGBTDEVICE

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.

Virtual reality-directed BGBT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Related Publications (1)

  • Gutermuth B, Jordan A, Hodish G, Sturgeon JA, DeJonckheere M, Berinstein JA, Sheehan J, Bishu S, Higgins PD, Cohen-Mekelburg S. Evaluation of a virtual reality-directed brain-gut behavioural treatment inpatient program for patients with inflammatory bowel disease: protocol for a pilot feasibility trial. BMJ Open. 2025 Jul 3;15(7):e098674. doi: 10.1136/bmjopen-2024-098674.

    PMID: 40615149DERIVED

MeSH Terms

Conditions

Inflammatory Bowel DiseasesPain

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Shirley Cohen-Mekelburg, MD, MS

    University of Michigan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shirley Cohen-Mekelburg, MD, MS

CONTACT

734-845-5735shcohen@med.umich.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 18, 2023

First Posted

January 3, 2024

Study Start

February 13, 2024

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

January 28, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)