Virtual Reality in the Management of Painful or Anxiety-provoking Procedures in Emergency Departments

Not yet recruiting

• Conditions: Pain and Anxiety; Dislocation; Suture

• Registration Number: NCT06425835
• Lead Sponsor: University of Monastir

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.

Study Timeline

• Study First Submitted: 2024-03-14
• Status Verified: 2024-05
• Study First Submitted QC: 2024-05-21
• Last Update Submitted: 2024-05-21
• Study First Posted: 2024-05-22
• Last Update Posted: 2024-05-22
• Study Start: 2024-08-15
• Primary Completion: 2026-05-15
• Study Completion: 2026-12-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
frequency of success	30 minutes	frequency of success (%) (use of emergency analgesics)

Secondary Outcome Measures

Name	Time	Method
reduction of pain	30 minutes	reduction in pain assessed by the visual analog scale (mm)