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

Dislocation Clinical Trial

— VR  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06425835
• Other study ID #: UMonastir2024
• Status: Not yet recruiting
• 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
• 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).

Related Conditions & MeSH terms

• Anxiety Disorders
• Dislocation
• Emergencies
• Pain and Anxiety
• Suture

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