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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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 300
Est. completion date December 15, 2026
Est. primary completion date May 15, 2026
Accepts healthy volunteers No
Gender All
Age group 9 Years to 24 Years
Eligibility Inclusion Criteria: - Patients aged 09 and 24 years - suturing a wound - changing a dressing - lumbar puncture, - peripheral venous line - blood test - intramuscular injection - reduction of a fracture - casting or plastering. Exclusion Criteria: - impaired consciousness - epilepsy - wound/infection covering the helmet area - headache - intellectual/mental retardation - nausea, vomiting - patient already included in the protocol - pain requiring immediate medical attention. analgesic (VAS >5 and described as intolerable).

Study Design


Intervention

Other:
VR device
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Monastir

Outcome

Type Measure Description Time frame Safety issue
Other occurrence of adverse events and patient satisfaction occurrence of adverse events, tolerance to glasses, patient satisfaction (Likert Satisfaction Scale) and max VAS during the procedure. 3 hours
Primary frequency of success frequency of success (%) (use of emergency analgesics) 30 minutes
Secondary reduction of pain reduction in pain assessed by the visual analog scale (mm) 30 minutes
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