Ignite Creation Date:
2024-07-17 @ 10:47 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06463210
Status:
COMPLETED
Last Update Posted:
2024-07-05
First Post:
2024-06-12
Brief Title:
Virtual Reality for Pain Management and Patient Satisfaction During Outpatient Hysteroscopy
Sponsor:
Hospital Universitario 12 de Octubre
Organization:
Hospital Universitario 12 de Octubre
Study Overview
Official Title:
Virtual Reality for Pain Management and Patient Satisfaction During Outpatient Hysteroscopy a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-06
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:
None
Brief Summary:
The investigators conducted a randomized controlled trial in 120 patients undergoing an outpatient hysteroscopy OH
60 patients were randomly allocated to the control group and 60 patients were randomly allocated to the study group
The intervention in the study group was to use a virtual reality VR device Meta Quest2 as a distraction technique during the OH
The investigators wanted to study if the distraction generated by the VR could improve patients perceived pain or satisfaction with the OH
60 patients were randomly allocated to the control group and 60 patients were randomly allocated to the study group
The intervention in the study group was to use a virtual reality VR device Meta Quest2 as a distraction technique during the OH
The investigators wanted to study if the distraction generated by the VR could improve patients perceived pain or satisfaction with the OH
Detailed Description:
The investigators conducted a randomized controlled trial in 120 patients undergoing an outpatient hysteroscopy OH
60 patients were randomly allocated to the control group and 60 patients were randomly allocated to the study group
In the standard hysteroscopy protocol all patients are advised to take an Ibuprofen 400-600mg or Paracetamol 650-1000 mg two hours before the procedure They are also suggested to take Bromazepam 15 mg two hours before the procedure if they feel anxious
The standard care group had a trained nurse providing distraction and emotional support
The study group had a VR device Meta Quest 2 with a video consisting of a gondola ride through the canals of Venice with relaxing music played on the headset The investigators wanted to study if the distraction generated by the VR could improve patients perceived pain or satisfaction with the OH comparing it with the standard care group
60 patients were randomly allocated to the control group and 60 patients were randomly allocated to the study group
In the standard hysteroscopy protocol all patients are advised to take an Ibuprofen 400-600mg or Paracetamol 650-1000 mg two hours before the procedure They are also suggested to take Bromazepam 15 mg two hours before the procedure if they feel anxious
The standard care group had a trained nurse providing distraction and emotional support
The study group had a VR device Meta Quest 2 with a video consisting of a gondola ride through the canals of Venice with relaxing music played on the headset The investigators wanted to study if the distraction generated by the VR could improve patients perceived pain or satisfaction with the OH comparing it with the standard care group
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