A Pilot Study to Assess the Safety, Tolerability, and Efficacy of Virtual Reality for the Treatment of Abdominal Pain in Quiescent Crohn's Disease

Last updated: September 7, 2025
Sponsor: Mayo Clinic
Overall Status: Active - Recruiting

Phase

N/A

Condition

Bowel Dysfunction

Ulcerative Colitis

Colic

Treatment

VR headset

Clinical Study ID

NCT06647615
24-001863
  • Ages 18-70
  • All Genders

Study Summary

The purpose of this research is to see if patients with Crohn's disease (CD) and abdominal pain resulting in health-related quality of life deficits despite lack of evidence of active inflammation improve with the use of virtual reality (VR).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with a diagnosis of endoscopically and histologically confirmed CD withevidence of C-reactive protein < 5 mg/dL and fecal calprotectin < 150microg/gwho also report any abdominal pain at least weekly will be included.

Exclusion

Exclusion Criteria:

  • Patients will be excluded from the study if they do not have biopsy-proven CD, havea known seizure disorder, if symptoms are thought to represent an organic disorder,those with visual or hearing impairments, if symptoms represent a known pelvic floordisorder, if the patient is using opioids, has significant ongoing psychologicaldistress (HAD score > 11 for either anxiety or depression), or if the patient cannot actively participate in the study for any other reason (e.g., inability tounderstand English as the VR program as an English only).

Study Design

Total Participants: 15
Treatment Group(s): 1
Primary Treatment: VR headset
Phase:
Study Start date:
May 24, 2024
Estimated Completion Date:
December 31, 2025

Study Description

The goal of this research is to see if patients with Crohn's disease (CD) and abdominal pain resulting in health-related quality of life deficits despite lack of evidence of active inflammation improve with the use of virtual reality (VR). The use of VR therapy is investigational. You have been asked to take part in this research because you have been identified as an adult with CD with abdominal pain at least weekly despite normal C-reactive protein and fecal calprotectin levels in adult patients, age 18- 70 years old. Demographic information will be gathered (age, sex, race, current medication use, co-morbid conditions), as will prior tests and interventions.

Participants will be asked to participate in the two-week pre-screening evaluation for symptoms through questionnaires. The VR portion of the study will last for 8 weeks. You will be asked to use your headset on a daily basis for at least 30 minutes, but you are free to use the headset as much as you would like. You will be called on a weekly basis.

Connect with a study center

  • Mayo Clinic Florida

    Jacksonville, Florida 32224
    United States

    Site Not Available

  • Mayo Clinic Florida

    Jacksonville 4160021, Florida 4155751 32224
    United States

    Active - Recruiting

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