Clinical trial NCT06647615: A Pilot Study to Assess the Safety, Tolerability, and Efficacy of Virtual Reality for the Treatment of Abdominal Pain in Quiescent Crohn's Disease
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Crohn's Disease
Abdominal Pain (AP)
Keywords: Crohn's Disease
Quiescent Crohn's Disease
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-10-18
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Improvement in abdominal pain
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Jami Kinnucan, MD
role: PRINCIPAL_INVESTIGATOR
References:
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