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Not yet recruiting NCT06425835

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

Observational Pain and Anxiety Dislocation Suture

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: VR device.
Who it may be relevant to
Registry conditions: Pain and Anxiety, Dislocation, Suture. Basic parameters: 9 years — 24 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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 wel

Primary outcome measures

  • frequency of success [Time frame: 30 minutes]
Secondary outcome measures (1)
  • reduction of pain [Time frame: 30 minutes]

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
  • 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06425835 · UMonastir2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗