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Clinical Trials/NCT06425835
NCT06425835
Not yet recruiting
Not Applicable

Virtual Reality in the Management of Painful or Anxiety-provoking Procedures in Emergency Departments: (Open Prospective Observational Study)

University of Monastir0 sites300 target enrollmentAugust 15, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain and Anxiety
Sponsor
University of Monastir
Enrollment
300
Primary Endpoint
frequency of success
Status
Not yet recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 15, 2024
End Date
December 15, 2026
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Pr. Semir Nouira

PROFESSOR

University of Monastir

Eligibility Criteria

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
  • wound/infection covering the helmet area
  • intellectual/mental retardation
  • nausea, vomiting
  • patient already included in the protocol
  • pain requiring immediate medical attention. analgesic (VAS \>5 and described as intolerable).

Outcomes

Primary Outcomes

frequency of success

Time Frame: 30 minutes

frequency of success (%) (use of emergency analgesics)

Secondary Outcomes

  • reduction of pain(30 minutes)

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