Inflammatory Bowel DiseasesNCT06188793
Virtual Reality (VR) -Directed Brain Gut Behavioral Treatment (BGBT) for Inflammatory Bowel Disease (IBD) Inpatients
A study testing Virtual reality-directed BGBT in people with Inflammatory Bowel Diseases, run by University of Michigan at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Virtual reality-directed BGBT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Inflammatory Bowel Disease and self-reported pain
- Hospitalized for management of IBD (inpatient medicine services at Michigan Medicine)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Shirley Cohen-Mekelburg, MD, MS, 734-845-5735, shcohen@med.umich.edu
Shirley Cohen-Mekelburg, MD, MS
About this study
Official title: Evaluation of a Virtual Reality-Directed Brain Gut Behavioral Treatment Inpatient Program for Patients With Inflammatory Bowel Disease
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.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Virtual reality-directed BGBT
- Keywords
- Virtual reality, Inpatient, Pain, Brain Gut Behavioral Treatment
- Medical subject headings
- Inflammatory Bowel Diseases, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality-directed BGBT | Experimental | Not described Receives: Device: Virtual reality-directed BGBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the intervention measured as the frequency (percentage) of enrolled participants that complete the VR-directed BGBT inpatient program
Measured: 3 days of treatment
Secondary outcomes (3)
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.
Measured: 1 week (semi-structured interview within 1 week of completion of the intervention)
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.
Measured: Day 3 (post intervention)
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.
Measured: Day 3 (post intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start13 Feb 2024
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shirley Cohen-Mekelburg, University of Michigan
- Investigators
- Shirley Cohen-Mekelburg, MD, MS, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06188793
- Sponsor's protocol ID
- HUM00240999
- Status last verified
- Jul 2026
- First submitted
- 18 Dec 2023
- Last updated
- 23 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40615149
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Virtual Reality-Directed Brain Gut Behavioral Treatment Inpatient Program for Patients With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT06188793
- Acronym / sponsor ID
- HUM00240999
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- Virtual reality, Inpatient, Pain, Brain Gut Behavioral Treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 13 Feb 2024 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 3 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual reality-directed BGBT | Experimental | Device: Virtual reality-directed BGBT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with Inflammatory Bowel Disease and self-reported pain
- Hospitalized for management of IBD (inpatient medicine services at Michigan Medicine)
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality-directed BGBTEnrolled 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. | Device | Virtual reality-directed BGBT |
Primary outcome
Feasibility of the intervention measured as the frequency (percentage) of enrolled participants that complete the VR-directed BGBT inpatient program
Time frame: 3 days of treatment
3 secondary outcomes
Intervention acceptability based on qualitative data and collected from audio-recordings of semi-structured interview
Time frame: 1 week (semi-structured interview within 1 week of completion of the intervention)
Acceptability using the System Usability Scale - patients
Time frame: Day 3 (post intervention)
Acceptability using the Treatment Acceptance and Adherence Scale- patients
Time frame: Day 3 (post intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Derived from this study: PubMed 40615149Gutermuth 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shirley Cohen-Mekelburg, MD, MS principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality-directed BGBT in people with Inflammatory Bowel Diseases, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shirley Cohen-Mekelburg, MD, MS (734-845-5735, shcohen@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the intervention measured as the frequency (percentage) of enrolled participants that complete the VR-directed BGBT inpatient program (time frame: 3 days of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06188793, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.