Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06647615
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-15
Brief Title:
A Pilot Study to Assess the Safety Tolerability and Efficacy of Virtual Reality for the Treatment of Abdominal Pain in Quiescent Crohns Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Pilot Study to Assess the Safety Tolerability and Efficacy of Virtual Reality for the Treatment of Abdominal Pain in Quiescent Crohns Disease
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this research is to see if patients with Crohns 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
Detailed Description:
The goal of this research is to see if patients with Crohns 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None