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NCT Number: NCT06188793

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

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.

Recruiting

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Key information

Conditions

Inflammatory Bowel Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location status: Recruiting

Location contact

Shirley Cohen-Mekelburg, MD, MS

CONTACT

[email protected]

734-845-5735

Shirley Cohen-Mekelburg, MD, MS

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual reality-directed BGBT

Device

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.

Primary outcomes

  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 outcomes

  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.

Study contacts

Contact information is provided by the study sponsor or research team.

Shirley Cohen-Mekelburg, MD, MS

CONTACT

[email protected]

734-845-5735

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 3, 2024
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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