Opioids for chronic noncancer pain: a meta-analysis of effectiveness and side effects.
Andrea D Furlan, Juan A Sandoval, Angela Mailis-Gagnon...
https://pubmed.ncbi.nlm.nih.gov/16717269Actively Recruiting
Phase Not Applicable
Age: 18Years - 70Years
All Genders
ID06647615
A Pilot Study to Assess the Safety, Tolerability, and Efficacy of Virtual Reality for Abdominal Pain Treatment in Quiescent Crohn's Disease
Led by Mayo Clinic · Updated on 2026-02-17
15
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research investigates whether virtual reality (VR) can improve abdominal pain and related quality of life issues in adults with Crohn's 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
Brief 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
Who Can Participate
Age: 18Years - 70Years
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 70 years
- Diagnosis of Crohn's disease confirmed by endoscopy and biopsy
- C-reactive protein level less than 5 mg/dL
- Fecal calprotectin level less than 150 microg/g
- Experience abdominal pain at least weekly
You will not qualify if you...
- No biopsy-proven Crohn's disease
- Known seizure disorder
- Symptoms considered to be from an organic disorder
- Visual or hearing impairments
- Known pelvic floor disorder symptoms
- Current use of opioid medications
- Significant psychological distress (HAD score over 11 for anxiety or depression)
- Inability to actively participate (e.g., inability to understand English)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Implementation
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
Trial Site Locations
Total: 1 location
1
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
Actively Recruiting
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Research Team
L
Lauren P Loeb, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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