Crohn'sRecruiting

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

Not applicable · Testing VR headset · 1 site · Mayo Clinic

Official record & contacts on ClinicalTrials.gov ↗

In plain English

What this trial is testing

This study is testing VR headset (a device) as a possible treatment. Condition(s) listed: Crohn's Disease and Abdominal Pain (AP).

It is open-label: participants know what they are receiving.

This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).

Who can join

Ages 18 to 70
Any sex

Some of the main requirements, copied from the record:

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.

There are also 1 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.

What's involved

About 15 participants are expected to take part.
Start date: 2024-05-24.
Main results expected around 2026-12-31 (estimate from the record).
1 study site listed (1 marked recruiting) in United States.

Main thing being measured

Improvement in abdominal pain (10 weeks)

In the researchers’ words

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).

This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.

Questions to ask your doctor and the trial team

Am I likely to qualify, given my health history?
What would I have to do, and how often would I need to visit?
Could I get a placebo? What happens to my current treatment?
What are the possible risks and benefits?
Are travel or other costs covered?
What happens after the trial ends?

Official details

Status	Recruiting
Phase	Not applicable
Study type	Interventional
Conditions	Crohn's Disease; Abdominal Pain (AP)
Lead sponsor	Mayo Clinic
Enrollment	15 (estimated)
Start date	2024-05-24
Primary completion (est.)	2026-12-31
First posted	2024-10-18
Last updated	2026-02-17
Official title	A Pilot Study to Assess the Safety, Tolerability, and Efficacy of Virtual Reality for the Treatment of Abdominal Pain in Quiescent Crohn's Disease
ClinicalTrials.gov ID	NCT06647615

Interventions

VR headset (Device)
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.

Full eligibility criteria (from the record)

Inclusion Criteria:

* Patients with a diagnosis of endoscopically and histologically confirmed CD with evidence of C-reactive protein \&lt; 5 mg/dL and fecal calprotectin \&lt; 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 \&gt; 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).

Locations (1)

Site	City	Country	Site status
Mayo Clinic Florida	Jacksonville, Florida	United States	Recruiting

For contacts at each site, use the official record.

Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.