Skip to content

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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06425835
Acronym
VR
Enrollment
300
Registered
2024-05-22
Start date
2024-08-15
Completion date
2026-12-15
Last updated
2024-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dislocation, Pain and Anxiety, Suture

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.

Interventions

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.

Sponsors

University of Monastir
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
9 Years to 24 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
frequency of success30 minutesfrequency of success (%) (use of emergency analgesics)

Secondary

MeasureTime frameDescription
reduction of pain30 minutesreduction in pain assessed by the visual analog scale (mm)

Other

MeasureTime frameDescription
occurrence of adverse events and patient satisfaction3 hoursoccurrence of adverse events, tolerance to glasses, patient satisfaction (Likert Satisfaction Scale) and max VAS during the procedure.

Contacts

Primary ContactNOUIRA Semir, PR
semir.nouira@rns.tn73106000
Backup ContactGANNOUN IMEN, ARC
gannounimen@yahoo.fr73106000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026