Clinical trial NCT06425835: Virtual Reality in the Management of Painful or Anxiety-provoking Procedures in Emergency Departments
Official title: Virtual Reality in the Management of Painful or Anxiety-provoking Procedures in Emergency Departments: (Open Prospective Observational Study)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pain and Anxiety
Dislocation
Suture
Lead sponsor: University of Monastir
Sponsor class: OTHER
First posted: 2024-05-22
Enrollment: 300
Sex: ALL
Minimum age (years): 9
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

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).

Primary outcomes:
measure: frequency of success
timeFrame: 30 minutes
Secondary outcomes:
measure: reduction of pain
timeFrame: 30 minutes
Other outcomes:
measure: occurrence of adverse events and patient satisfaction
timeFrame: 3 hours
Locations:
Study officials:
References: