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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VR Headset | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lauren P Loeb, MD | Contact | 904-953-6970 | loeb.lauren@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jami Kinnucan, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Florida | Recruiting | Jacksonville | Florida | 32224 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16717269 | Background | 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. | |
| 30430615 | 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. |
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| 24892196 | 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. |
| 28356241 | 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. |
| 36866110 | 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. |
| 22298998 | Background | Docherty MJ, Jones RC 3rd, Wallace MS. Managing pain in inflammatory bowel disease. Gastroenterol Hepatol (N Y). 2011 Sep;7(9):592-601. |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D015746 | Abdominal Pain |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
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