Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT06425835 |
Other study ID # |
UMonastir2024 |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
August 15, 2024 |
Est. completion date |
December 15, 2026 |
Study information
Verified date |
May 2024 |
Source |
University of Monastir |
Contact |
NOUIRA Semir, PR |
Phone |
73106000 |
Email |
semir.nouira[@]rns.tn |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
Study and evaluate the effectiveness of virtual reality in pain management.
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.