Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06622408
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-18
Brief Title:
Contribution of Virtual Reality in the Management of Patients Undergoing Scheduled Cesarean Section - VR-SCS
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Contribution of Virtual Reality in the Management of Patients Undergoing Scheduled Cesarean Section - VR-SCS Study Virtual Reality and Schedulded Cesarean Section
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
VR-SCS
Brief Summary:
Cesarean deliveries account for 207 of all deliveries in France according to the latest perinatal survey At Nice University Hospital the C-section rate over the last 5 years is around 19
Caesarean section patients are at greater risk of developing symptoms of anxiety stress and depression The post-operative period is also more painful and there is a positive correlation between immediate post-operative pain and the risk of developing chronic pelvic pain Numerous attempts to reduce these symptoms have been evaluated including music therapy relaxation techniques acupressure and the use of preoperative melatonin
Virtual reality has demonstrated its effectiveness in reducing pain and anxiety in other disciplines notably pediatric surgery and neurosurgery
In particular several trials have demonstrated a reduction in anxiety in the paediatric population and for pelvic procedures under local anaesthetic during prostate biopsies or hysteroscopy in consultation with a reduction in anxiety and pain respectively
It has been used to provide information by showing a film about the caesarean section procedure and has been shown to be effective in terms of patient satisfaction but without being able to demonstrate a significant reduction in anxiety p006
The use of virtual reality during the entire peri- and intra-operative management process maternity stay patient transfer to the operating room locoregional anesthesia procedure and during the operation has not been studied in the context of cesarean section
Caesarean section patients are at greater risk of developing symptoms of anxiety stress and depression The post-operative period is also more painful and there is a positive correlation between immediate post-operative pain and the risk of developing chronic pelvic pain Numerous attempts to reduce these symptoms have been evaluated including music therapy relaxation techniques acupressure and the use of preoperative melatonin
Virtual reality has demonstrated its effectiveness in reducing pain and anxiety in other disciplines notably pediatric surgery and neurosurgery
In particular several trials have demonstrated a reduction in anxiety in the paediatric population and for pelvic procedures under local anaesthetic during prostate biopsies or hysteroscopy in consultation with a reduction in anxiety and pain respectively
It has been used to provide information by showing a film about the caesarean section procedure and has been shown to be effective in terms of patient satisfaction but without being able to demonstrate a significant reduction in anxiety p006
The use of virtual reality during the entire peri- and intra-operative management process maternity stay patient transfer to the operating room locoregional anesthesia procedure and during the operation has not been studied in the context of cesarean section
Detailed Description:
None
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