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

NCT06647615 | Recruiting DMC FDA Device

• 1 other identifier: 24-001863
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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).

Conditions

Crohn's Disease; Abdominal Pain (AP)

Keywords

Crohn's Disease; Quiescent Crohn's Disease

Outcome Measures

Primary Outcomes (1)

• Improvement in abdominal pain

  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.

  10 weeks

Study Arms (1)

VR Headset

EXPERIMENTAL

Device: VR headset

Interventions

VR headset DEVICE

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.

VR Headset

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

RECRUITING

Related Publications (6)

• Furlan AD, Sandoval JA, Mailis-Gagnon A, Tunks E. Opioids for chronic noncancer pain: a meta-analysis of effectiveness and side effects. CMAJ. 2006 May 23;174(11):1589-94. doi: 10.1503/cmaj.051528.

  PMID: 16717269 BACKGROUND

• Noureldin M, Higgins PDR, Govani SM, Cohen-Mekelburg S, Kenney BC, Stidham RW, Waljee JF, Waljee AK. Incidence and predictors of new persistent opioid use following inflammatory bowel disease flares treated with oral corticosteroids. Aliment Pharmacol Ther. 2019 Jan;49(1):74-83. doi: 10.1111/apt.15023. Epub 2018 Nov 14.

  PMID: 30430615 BACKGROUND

• Wiederhold BK, Gao K, Sulea C, Wiederhold MD. Virtual reality as a distraction technique in chronic pain patients. Cyberpsychol Behav Soc Netw. 2014 Jun;17(6):346-52. doi: 10.1089/cyber.2014.0207.

  PMID: 24892196 BACKGROUND

• Tashjian VC, Mosadeghi S, Howard AR, Lopez M, Dupuy T, Reid M, Martinez B, Ahmed S, Dailey F, Robbins K, Rosen B, Fuller G, Danovitch I, IsHak W, Spiegel B. Virtual Reality for Management of Pain in Hospitalized Patients: Results of a Controlled Trial. JMIR Ment Health. 2017 Mar 29;4(1):e9. doi: 10.2196/mental.7387.

  PMID: 28356241 BACKGROUND

• Lacy BE, Cangemi DJ, Spiegel BR. Virtual Reality: A New Treatment Paradigm for Disorders of Gut-Brain Interaction? Gastroenterol Hepatol (N Y). 2023 Feb;19(2):86-94.

  PMID: 36866110 BACKGROUND

• Docherty MJ, Jones RC 3rd, Wallace MS. Managing pain in inflammatory bowel disease. Gastroenterol Hepatol (N Y). 2011 Sep;7(9):592-601.

  PMID: 22298998 BACKGROUND

MeSH Terms

Conditions

Crohn Disease; Abdominal Pain

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Officials

• Jami Kinnucan, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lauren P Loeb, MD

CONTACT

904-953-6970; loeb.lauren@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: October 18, 2024
• Study Start: May 24, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

US (1)