RightFit
RecruitingNot applicable

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 70 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 8 weeks
  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether virtual reality (VR) is safe, easy to tolerate, and helps with belly pain. It is for people with Crohn's disease who have pain that affects their quality of life, even though tests show no active inflammation (swelling).

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have Crohn's disease confirmed by a scope exam of the gut and a biopsy (testing a small tissue sample).
  • Have a C-reactive protein blood test result below 5 mg/dL and a fecal calprotectin stool test result below 150 micrograms/g. These tests check for inflammation.
  • Have belly pain at least once a week.

Who can't join

  • Do not have Crohn's disease confirmed by a biopsy.
  • Have a known seizure disorder.
  • Have symptoms thought to come from another physical disease or condition.
  • Have trouble seeing or hearing.
  • Have symptoms caused by a known problem with the pelvic floor (muscles that support the bladder and bowel).
  • Use opioid pain medicines.
  • Have major ongoing emotional distress, with a HAD questionnaire score above 11 for anxiety or depression.
  • Cannot take an active part in the study for any other reason, such as not understanding English. The VR program is only in English.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

FL