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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorMayo Clinic

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: VR HeadsetExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
10 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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