Abdominal Pain (AP) · Crohn's Disease
Virtual reality for abdominal pain in adults with quiescent Crohn’s disease
This pilot study is investigating whether eight weeks of daily virtual reality use affects abdominal pain in adults with Crohn’s disease who have weekly pain despite no reported evidence of active inflammation.
Registry 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
1 recruiting U.S. site ↓Study at a glance
- Age
- 18 Years–70 Years
- Treatment
- VR headset
- Design
- Not provided
- Central study contact
- Lauren P Loeb, MD904-953-6970loeb.lauren@mayo.edu
- Sponsor
- Mayo Clinic
Research question
Among adults with Crohn’s disease, weekly abdominal pain, and no reported evidence of active inflammation, does daily virtual reality use improve abdominal pain and health-related quality-of-life deficits?
Participant snapshot
Who the study is looking for
- The study is looking for adults ages 18 through 70.
- The study is looking for people with Crohn’s disease confirmed by endoscopy, tissue examination, and biopsy.
- The study is looking for people who report abdominal pain at least weekly.
- The study is looking for people whose C-reactive protein is below 5 mg/dL and fecal calprotectin is below 150 micrograms/g.
- The recruiting location listed in the registry is Mayo Clinic Florida in Jacksonville.
Participation overview
What participation may involve
Participation includes a two-week symptom pre-screening period followed by eight weeks of daily virtual reality headset use, with weekly telephone calls. What participation may involve: - Complete symptom questionnaires during a two-week pre-screening evaluation. - Use the virtual reality headset daily for at least 30 minutes during the eight-week virtual reality period. - Take part in a telephone call each week. - Provide demographic information, current medication use, coexisting conditions, and information about prior tests and interventions. The registry reports a two-week pre-screening period and an eight-week virtual reality period.
Study interventions
What participants may receive or do
- VR headset: Participants are asked to use a virtual reality headset every day for at least 30 minutes during the eight-week virtual reality portion of the study; they may use it longer if they wish.
Study design
How the comparison works
This is an interventional pilot study planning to enroll 15 participants in one experimental virtual reality group, with no masking. The registry reports no masking, meaning participants and study personnel are not described as blinded to the virtual reality intervention. The registry lists one experimental virtual reality group and does not describe a separate comparison group. No placebo or sham intervention is listed in the registry record.
Reported activities
Procedures and tests
- Symptom questionnaires are completed during the two-week pre-screening evaluation.
- Participants use a virtual reality headset daily for at least 30 minutes during the eight-week intervention period.
- Participants receive a telephone call each week.
- Abdominal pain is assessed using a 0-to-10 Likert pain scale, with the primary comparison reported at week 10 versus baseline.
- The study gathers age, sex, race, current medication use, coexisting conditions, and information about prior tests and interventions.
- Screening may involve confirming prior endoscopic, tissue, and biopsy evidence of Crohn’s disease and the required C-reactive protein and fecal calprotectin results.
- The Hospital Anxiety and Depression scale is referenced in the exclusion criteria, with a score above 11 for either anxiety or depression listed as exclusionary.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- Crohn’s disease must be confirmed by endoscopy and tissue examination.
- C-reactive protein must be below 5 mg/dL.
- Fecal calprotectin must be below 150 micrograms/g.
- Abdominal pain must occur at least weekly.
- The registry’s stated age range is 18 through 70 years.
Possible reasons someone may not be able to join
- People without biopsy-confirmed Crohn’s disease are excluded.
- A known seizure disorder is exclusionary.
- People are excluded if their symptoms are thought to represent an organic disorder.
- Visual or hearing impairments are exclusionary.
- Symptoms attributed to a known pelvic floor disorder are exclusionary.
- Current opioid use is exclusionary.
- A Hospital Anxiety and Depression score above 11 for either anxiety or depression is exclusionary.
- A person must be able to participate actively and understand English because the virtual reality program is available only in English.
Important unknowns
What the record does not make clear
- Weekly telephone calls are reported, but the number and timing of in-person or video visits are not provided.
- The registry says current medications will be recorded but does not say which Crohn’s disease treatments may continue during the study.
- The registry excludes opioid use but does not provide medication washout requirements or timing.
- The record does not describe what treatment is allowed if abdominal pain worsens during the study.
- Prior endoscopic and histologic confirmation of Crohn’s disease is required, but the record does not say whether a new endoscopy or biopsy is needed.
- The registry does not state which study-related care or equipment is paid for or billed to insurance.
- Compensation or reimbursement is not described.
- Travel or lodging support is not described.
- Daily headset use and weekly calls are described, but the registry does not say whether all other study activities can be completed remotely.
- The record does not say whether participants may keep or continue using the headset after the study.
Before contacting the site
Questions for the study team
- What in-person, video, and telephone visits are required, and how long does each take?
- Can existing endoscopy, biopsy, C-reactive protein, and fecal calprotectin results be used for screening?
- Which Crohn’s disease medicines and pain treatments must remain stable, may continue, or must be stopped?
- What should a participant do, and what treatments are allowed, if abdominal pain or Crohn’s symptoms worsen?
- Are there side effects or safety concerns associated with the headset, especially for people with motion sensitivity, headaches, or balance problems?
- Which study activities can be completed at home, and is travel to Jacksonville required?
- Are the headset, study procedures, parking, or travel covered, and is compensation available?
- May participants keep or continue using the virtual reality program after the eight-week intervention?
Before changing care
Questions for your gastroenterologist
- Do my recent symptoms and test results support the study’s description of Crohn’s disease without active inflammation?
- Would changing or pausing any of my current Crohn’s disease or pain treatments create clinical concerns?
- What approved treatment alternatives should we consider for ongoing abdominal pain when inflammation appears controlled?
- Are there aspects of my medical history that could make virtual reality use or study participation riskier for me?
- How should you and the research team coordinate if my abdominal pain worsens or signs of active Crohn’s disease appear?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
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).
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.
Study design and administration
- Organization
- Mayo Clinic
- Organization class
- Other
- Organization study ID
- 24-001863
- Lead sponsor
- Mayo Clinic
- Sponsor class
- Other
- Enrollment type
- Estimated
- Allocation
- Na
- Intervention model
- Single Group
- Primary purpose
- Treatment
- Masking
- None
- Who is masked
- Not provided
- Standard age groups
- Adult, Older Adult
Study arms
Experimental
VR Headset
Interventions: Device: VR headset
Interventions
Device
VR headset
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.
Eligibility
18 Years–70 Years
All
Not accepted
Inclusion criteria (1)
- 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.Registry-derived · unreviewed
Exclusion criteria (1)
- 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).Registry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
Improvement in abdominal pain
Time frame: 10 weeks
Improvement in mean abdominal pain by 25% at week 10 as compared to baseline in patients with quiescent CD using the 0-10 Likert pain scale.
Recruiting locations in the United States
Mayo Clinic Florida
RecruitingJacksonville, Florida, 32224, United States
Jami Kinnucan, MD904-953-6970researchparticipantadvocate@mayo.edu
Jami Kinnucan, MD
Central study contacts
Registry dates
- First posted
- Oct 18, 2024
- Primary completion
- Dec 31, 2026
- Overall completion
- Dec 31, 2026
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.