Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2026-01-03 @ 8:22 AM
Study NCT ID:
NCT06425835
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Reality in the Management of Painful or Anxiety-provoking Procedures in Emergency Departments
Sponsor:
University of Monastir
Organization:
Study Overview
Official Title:
Virtual Reality in the Management of Painful or Anxiety-provoking Procedures in Emergency Departments: (Open Prospective Observational Study)
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
VR
Brief Summary:
Study and evaluate the effectiveness of virtual reality in pain management.
Detailed Description:
Study and evaluate the effectiveness of virtual reality in pain management.This is an open prospective observational study carried out at Urgences Fattouma Bourgiba Monastir.
For all patients included, a data collection form must be completed, mentioning age, sex, medical and surgical history, and the type of procedure planned.
* If initial VAS \>5 and intolerable: patients will immediately use painkillers and will be excluded from the study.
* If initial VAS \<=5 or \> 5 but tolerable: Only VR glasses are used as an analgesic.
If during the procedure the patient describes intolerable pain: the VAS will be noted, and the patient will use a rescue analgesic (intranasal ketamine or other at the discretion of the attending physician).
The VR device consists of a pair of VR glasses with a video previously chosen and installed. Patient preparation must be done before initiating the protocol.
The first step is to choose patient candidates for VR who are understanding and interested. Guardian approval is required; then it is necessary to explain the principle, the stages and the benefits of the care.
The intensity of pain is calculated according to the visual analog scale before, during the procedure and 30 minutes after as well as the max VAS during the procedure, the 'Children Fear Scale', the satisfaction score and any adverse effects are noted.
For all patients included, a data collection form must be completed, mentioning age, sex, medical and surgical history, and the type of procedure planned.
* If initial VAS \>5 and intolerable: patients will immediately use painkillers and will be excluded from the study.
* If initial VAS \<=5 or \> 5 but tolerable: Only VR glasses are used as an analgesic.
If during the procedure the patient describes intolerable pain: the VAS will be noted, and the patient will use a rescue analgesic (intranasal ketamine or other at the discretion of the attending physician).
The VR device consists of a pair of VR glasses with a video previously chosen and installed. Patient preparation must be done before initiating the protocol.
The first step is to choose patient candidates for VR who are understanding and interested. Guardian approval is required; then it is necessary to explain the principle, the stages and the benefits of the care.
The intensity of pain is calculated according to the visual analog scale before, during the procedure and 30 minutes after as well as the max VAS during the procedure, the 'Children Fear Scale', the satisfaction score and any adverse effects are noted.
Study Oversight
Has Oversight DMC:
False
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?: