Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06414239
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-04-29
Brief Title:
Improvement of Lower Digestive Endoscopy Without Anesthesia Evaluation of the Virtual Reality Mask
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Amélioration du Taux de succès de la Coloscopie Totale Lors Des Endoscopies Digestives Sans anesthésie évaluation du Masque de réalité Virtuelle
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REVENDO
Brief Summary:
90 of colonoscopies are performed with general anesthesia GA GA carries risks and requires a prior anesthesia consultation a dedicated team and technical platform on the day of the examination These constraints increase the time it takes to organize examinations This was particularly highlighted during the recent health crisis The success of colonoscopy without GA varies depending on the patients experience of the examination Any measure allowing better tolerance of the exam is therefore likely to increase its success rate and avoid rescheduling the exam under GA A 2017 meta-analysis showed that the use of virtual reality VR reduced pain and anxiety during care for burn victims in trauma and oncology In upper digestive endoscopy retrospective studies have shown good tolerability of the examinations and a reduction in pain compared to patients with only local anesthesia Thus if the VR mask improves the success rate of total colonoscopy by improving tolerance and acceptability more examinations without GA could be considered It could also have an economic impact
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None