Virtual Reality in the Management of Painful or Anxiety-provoking Procedures in Emergency Departments
VR
1 other identifier
observational
300
0 countries
N/A
Brief Summary
Study and evaluate the effectiveness of virtual reality in pain management.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2024
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 14, 2024
CompletedFirst Posted
Study publicly available on registry
May 22, 2024
CompletedStudy Start
First participant enrolled
August 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 15, 2026
May 22, 2024
May 1, 2024
1.7 years
March 14, 2024
May 21, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
frequency of success
frequency of success (%) (use of emergency analgesics)
30 minutes
Secondary Outcomes (1)
reduction of pain
30 minutes
Other Outcomes (1)
occurrence of adverse events and patient satisfaction
3 hours
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.
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PROFESSOR
Study Record Dates
First Submitted
March 14, 2024
First Posted
May 22, 2024
Study Start
August 15, 2024
Primary Completion (Estimated)
May 15, 2026
Study Completion (Estimated)
December 15, 2026
Last Updated
May 22, 2024
Record last verified: 2024-05