Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06632691
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-07
Brief Title:
Virtual Reality Headset and Acceptability of Rectosigmoidoscopy in Ulcerative Colitis a Randomised Controlled Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Virtual Reality Headset and Acceptability of Rectosigmoidoscopy in Ulcerative Colitis a Randomised Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-10
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:
VIRTU
Brief Summary:
Haemorrhagic rectocolitis is an inflammatory bowel disease that continuously affects the rectum and colon with lesions that extend variably from the rectum into the upstream colon This disease requires repeated assessment of both clinical activity transcribed by the clinical Mayo score and endoscopic activity ACCEPT study showed that the acceptability of rectosigmoidoscopy is low and the main determinants of this low acceptability were pain and bloating 51 and embarrassment during the examination 30
Virtual reality headsets has analgesic and anxiolytic properties thanks to specially designed virtual environments that apply different principles such as medical hypnosis music therapy and cardiac coherence to enhance therapeutic action
The aim of our project is to study the benefit of medical hypnosis provided by the use of a virtual reality headset in terms of tolerance of lower digestive endoscopy in patients with ulcerative colitis
Virtual reality headsets has analgesic and anxiolytic properties thanks to specially designed virtual environments that apply different principles such as medical hypnosis music therapy and cardiac coherence to enhance therapeutic action
The aim of our project is to study the benefit of medical hypnosis provided by the use of a virtual reality headset in terms of tolerance of lower digestive endoscopy in patients with ulcerative colitis
Detailed Description:
Haemorrhagic rectocolitis is an inflammatory bowel disease that continuously affects the rectum and colon with lesions that extend variably from the rectum into the upstream colon
This disease requires repeated assessment of both clinical activity transcribed by the clinical Mayo score and endoscopic activity Assessment of mucosal healing is one of the therapeutic objectives defined in the STRIDE II consensus and requires regular repeat endoscopic examinations in these patients
The aim of the ACCEPT study which involved administering a questionnaire to 916 patients with chronic inflammatory bowel disease was to assess patients acceptability and perceived usefulness of examinations designed to assess the activity of chronic inflammatory bowel disease This study showed that the acceptability of rectosigmoidoscopy is low and the main determinants of this low acceptability were pain and bloating 51 and embarrassment during the examination 30
The dominant approaches to addressing this issue focus on replacing rectosigmoidoscopy with less invasive tools such as ultrasound and faecal calprotectin However rectosigmoidoscopy is still unavoidable particularly for rectal forms poor performance of ultrasound low reliability of faecal calprotectin
Virtual reality headsets are now part of our everyday lives Developed as part of the neurosciences they have applications in healthcare pain care dementia post-traumatic stress disorder etc occupational risk prevention and leisure escape games video games
This device has analgesic and anxiolytic properties thanks to specially designed virtual environments that apply different principles such as medical hypnosis music therapy and cardiac coherence to enhance therapeutic action
This approach has been evaluated in endoscopy to improve the tolerance of colorectal cancer screening colonoscopies A Chinese study Liu et al Clinical medicine 2022 which included 120 patients in a randomised trial comparing the virtual reality headset with a headset that was switched off showed that the headset that was switched on made it possible to gain a median of 2 points on the pain scale to reduce skin conductance an indirect marker of nervousness and to improve patient satisfaction We hypothesise that the gain in SR would be the same with an examination that is reputed to be less painful than colonoscopy without anaesthetic
The aim of our project is to study the benefit of medical hypnosis provided by the use of a virtual reality headset in terms of tolerance of lower digestive endoscopy in patients with ulcerative colitis
This disease requires repeated assessment of both clinical activity transcribed by the clinical Mayo score and endoscopic activity Assessment of mucosal healing is one of the therapeutic objectives defined in the STRIDE II consensus and requires regular repeat endoscopic examinations in these patients
The aim of the ACCEPT study which involved administering a questionnaire to 916 patients with chronic inflammatory bowel disease was to assess patients acceptability and perceived usefulness of examinations designed to assess the activity of chronic inflammatory bowel disease This study showed that the acceptability of rectosigmoidoscopy is low and the main determinants of this low acceptability were pain and bloating 51 and embarrassment during the examination 30
The dominant approaches to addressing this issue focus on replacing rectosigmoidoscopy with less invasive tools such as ultrasound and faecal calprotectin However rectosigmoidoscopy is still unavoidable particularly for rectal forms poor performance of ultrasound low reliability of faecal calprotectin
Virtual reality headsets are now part of our everyday lives Developed as part of the neurosciences they have applications in healthcare pain care dementia post-traumatic stress disorder etc occupational risk prevention and leisure escape games video games
This device has analgesic and anxiolytic properties thanks to specially designed virtual environments that apply different principles such as medical hypnosis music therapy and cardiac coherence to enhance therapeutic action
This approach has been evaluated in endoscopy to improve the tolerance of colorectal cancer screening colonoscopies A Chinese study Liu et al Clinical medicine 2022 which included 120 patients in a randomised trial comparing the virtual reality headset with a headset that was switched off showed that the headset that was switched on made it possible to gain a median of 2 points on the pain scale to reduce skin conductance an indirect marker of nervousness and to improve patient satisfaction We hypothesise that the gain in SR would be the same with an examination that is reputed to be less painful than colonoscopy without anaesthetic
The aim of our project is to study the benefit of medical hypnosis provided by the use of a virtual reality headset in terms of tolerance of lower digestive endoscopy in patients with ulcerative colitis
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