Managing pain in inflammatory bowel disease.
Michael J Docherty, R Carter W Jones, Mark S Wallace
https://pubmed.ncbi.nlm.nih.gov/22298998/Actively Recruiting
Led by Mayo Clinic · Updated on 2026-02-17
15
Participants Needed
1
Research Sites
N/A
Total Duration
This research investigates whether virtual reality VR can improve abdominal pain and related quality of life issues in adults with Crohns disease CD who do not show signs of active inflammation. It focuses on patients aged 18 to 70 years who experience abdominal pain at least weekly despite normal inflammation markers. The study is a pilot trial assessing the safety, tolerability, and effectiveness of VR therapy for this condition. Participants will use a VR headset daily for at least 30 minutes over an 8-week period, with the freedom to use it longer if desired. Before starting VR treatment, there is a two-week pre-screening phase involving symptom questionnaires. Weekly phone calls will support and monitor participants during the VR treatment phase. During the study, demographic and medical information will be collected, including age, sex, race, medications, and other health conditions. Researchers will assess improvement in abdominal pain over 10 weeks as the primary outcome. This includes monitoring symptoms through questionnaires and weekly calls to understand how VR therapy impacts pain and quality of life in this group.
CONDITIONS
A Pilot Study to Assess the Safety, Tolerability, and Efficacy of Virtual Reality for the Treatment of Abdominal Pain in Quiescent Crohn's Disease
L
Lauren P Loeb, MD
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Mayo Clinic
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | VR Headset (Trial Arm) | Current Guideline-Based Management |
|---|---|---|
| What it is | An investigational digital therapy using a VR headset, intended for daily home use of at least 30 minutes to relieve abdominal pain. | Medical management guided by pain relief principles in Crohn's Disease, focusing on non-opioid options like anti-inflammatory therapy, antispasmodics, psychological support, and avoidance of chronic opioids. |
| Primary use | To assess whether daily VR headset use can reduce abdominal pain for adults with stabilized Crohn's Disease. | To control abdominal pain and improve patient quality of life, using guideline-supported non-opioid pharmacological and supportive therapies. |
| How it is given or performed | Participants are instructed to use the VR headset at home at least 30 minutes every day for 8 weeks. | Guided by treating physician, medical management may include anti-inflammatory drugs, antispasmodics, psychological interventions, and routine follow-up; opioid use is discouraged especially in stable/low-inflammation disease. |
| Evidence status | Clinical efficacy, tolerability, and safety in Crohn's Disease are not yet established; prior VR studies suggest benefit for general chronic pain but not specifically in this population. | Pain management for Crohn's Disease is supported by published guideline consensus, with anti-inflammatory and supportive therapies preferred; chronic opioid therapy poses significant risks and is discouraged except in specific acute settings. |
| Important limitations | Small pilot trial, unknown long-term safety in Crohn's Disease, device usability may be affected by visual or hearing impairment, psychological distress, or inability to participate independently. Not tested against standard medical management. | Some patients continue to experience pain despite guideline medical therapy; chronic opioid use may be associated with persistent pain, psychological comorbidities, and increased risk for dependency. Non-opioid therapies may be insufficient for all patients. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 8 weeks
Participants use the VR headset daily to help treat abdominal pain associated with Crohn's disease.
Daily use of VR headset for at least 30 minutes and weekly phone calls
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Lead Sponsor