Recruiting

Virtual Reality

Sponsor:

Mayo Clinic

Code:

NCT06647615

Conditions

Crohn's Disease

Abdominal Pain (AP)

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

VR headset

Study Details

Brief 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).

Conditions

Crohn's Disease

Abdominal Pain (AP)

Study ID

NCT06647615

Start date

May 24, 2024

Status verified date

Feb, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: VR Headset

Interventions

VR headset

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.

Primary outcome measure

  • Improvement in abdominal pain [ Time Frame: 10 weeks ]

Central Contacts and Locations

Central contacts

Lauren P Loeb, MD

904-953-6970loeb.lauren@mayo.edu

Locations

Mayo Clinic Florida

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Jami Kinnucan, MD

904-953-6970researchparticipantadvocate@mayo.edu

Principal Investigator:

Jami Kinnucan, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Feb 17, 2026

Last verified

Feb, 2026

Keywords

  • Crohn's Disease
  • Quiescent Crohn's Disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-02-17.