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

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ClinicalTrials.gov Identifier: NCT06188793
Recruitment Status : Recruiting
First Posted : January 3, 2024
Last Update Posted : February 16, 2024
Sponsor:
Information provided by (Responsible Party):
Shirley Cohen-Mekelburg, University of Michigan

Study Description
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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.

Condition or disease Intervention/treatment Phase
Inflammatory Bowel Diseases Device: Virtual reality-directed BGBT Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of a Virtual Reality-Directed Brain Gut Behavioral Treatment Inpatient Program for Patients With Inflammatory Bowel Disease
Actual Study Start Date : February 13, 2024
Estimated Primary Completion Date : July 2025
Estimated Study Completion Date : July 2025
Arms and Interventions
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Arm Intervention/treatment
Experimental: Virtual reality-directed BGBT 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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) ]
    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.

  2. Acceptability using the System Usability Scale - patients [ Time Frame: Day 3 (post intervention) ]
    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.

  3. Acceptability using the Treatment Acceptance and Adherence Scale- patients [ Time Frame: Day 3 (post intervention) ]

    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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06188793


Contacts
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Contact: Shirley Cohen-Mekelburg, MD, MS 734-845-5735 shcohen@med.umich.edu

Locations
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United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Shirley Cohen-Mekelburg, MD, MS    734-845-5735    shcohen@med.umich.edu   
Principal Investigator: Shirley Cohen-Mekelburg, MD, MS         
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Shirley Cohen-Mekelburg, MD, MS University of Michigan
More Information
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Responsible Party: Shirley Cohen-Mekelburg, Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT06188793    
Other Study ID Numbers: HUM00240999
First Posted: January 3, 2024    Key Record Dates
Last Update Posted: February 16, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shirley Cohen-Mekelburg, University of Michigan:
Virtual reality
Inpatient
Pain
Brain Gut Behavioral Treatment
Additional relevant MeSH terms:
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Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis