Clinical trial

Pilot Study on the Evaluation of the Effectiveness of a Virtual Reality Device on Anxiety During Procedural Sedation in Traumatology in Emergency Department

Name
VIRTUAL DREAM
Description
The aim of this study is to evaluate the efficiency of a reality device and a virtual hypnosis software to reduce the anxiety during reduction procedure in traumatology in an emergency department. These devices have recently been evaluated in the management of pain and anxiety in different specialties but never in the context of analgesia-sedation protocols in emergencies.
Trial arms
Trial start
2021-07-20
Estimated PCD
2023-01-18
Trial end
2023-01-18
Status
Completed
Treatment
Experimental : Virtual reality + analgesia-sedation
Use of a virtual reality device + analgesia-sedation drugs according to SFMU/SFAR 2010 guidelines during reduction procedure
Arms:
Experimental : Virtual reality + analgesia-sedation
Control: Analgesia-sedation
Use of analgesia-sedation drugs according to SFMU/SFAR 2010 guidelines during reduction procedure
Arms:
Control: Analgesia-sedation
Size
60
Primary endpoint
Difference in anxiety level
30 minutes
Eligibility criteria
Inclusion Criteria: * Patient aged 18 years or older * Patient suffering from one of the following traumatic pathologies requiring a technical procedure in the emergency room Shoulder dislocation Ankle dislocation Elbow dislocation Wrist dislocation Reducible fractures * No contraindication to Virtual Reality * No contraindication to morphine, ketamine, propofol, paracetamol, nefopam and MEOPA * Patient having given oral, free and informed consent Exclusion Criteria: * Patients suffering from mono or binocular blindness * Patient under the influence of alcohol or psychotropic drugs * Patient presenting a psychosis and/or a state of agitation, and/or a state of confusion. * Patient presenting a hemodynamic, respiratory or neurological failure * Patient with at least one of the following symptoms at the time of inclusion in the study: headache, dizziness, nausea, vomiting * Persons benefiting from reinforced protection, i.e. minors, persons deprived of their liberty by a judicial or administrative decision, adults under legal protection (guardianship and trusteeship) and finally patients in a vital emergency situation. * Pregnant or breastfeeding women, women of childbearing age who do not have effective contraception (hormonal/mechanical: per os, injectable, transcutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total oophorectomy) * Concurrent participation in another clinical research study whose objective is the evaluation of anxiety and/or pain
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 60, 'type': 'ACTUAL'}}
Updated at
2024-01-11

1 organization

1 product

4 indications

Product
Control
Indication
Reality Device
Indication
Fracture
Indication
Dislocation