Virtual Reality in the Management of Painful or Anxiety-provoking Procedures in Emergency Departments
NCT ID: NCT06425835
Last Updated: 2024-05-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
300 participants
OBSERVATIONAL
2024-08-15
2026-12-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Healthy Volunteer Undergoing Painful Stimuli With and Without Hypnosis and Virtual Reality
NCT04107558
Virtual Reality Use for Peri-Procedural Analgesia and Anxiolysis
NCT04218396
Pilot Study on the Evaluation of the Effectiveness of a Virtual Reality Device on Anxiety During Procedural Sedation in Traumatology in Emergency Department
NCT04936880
Virtual Reality Therapy for Pain Management at the Emergency Department
NCT06089642
Effect of VR on Anxiety and Pain in Gynecological Surgery
NCT04687501
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* suturing a wound
* changing a dressing
* lumbar puncture,
* peripheral venous line
* blood test
* intramuscular injection
* reduction of a fracture
* casting or plastering.
Exclusion Criteria
* 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).
9 Years
24 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Monastir
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Pr. Semir Nouira
PROFESSOR
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
UMonastir2024
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.