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

Poitiers University Hospital

Status: Completed

Conditions: Dislocation; Fracture; Reality Device; Reduction Procedure

Treatments: Device: Experimental : Virtual reality + analgesia-sedation; Drug: Control: Analgesia-sedation

Study type: Interventional

Funder types: Other

Identifiers

NCT04936880

VIRTUAL DREAM

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Experimental : Virtual reality + analgesia-sedation

Experimental group

Description:

Use of a virtual reality device + analgesia-sedation drugs according to SFMU/SFAR 2010 guidelines during reduction procedure

Treatment:

Device: Experimental : Virtual reality + analgesia-sedation

Control: Analgesia-sedation

Active Comparator group

Description:

Use of analgesia-sedation drugs according to SFMU/SFAR 2010 guidelines during reduction procedure

Treatment:

Drug: Control: Analgesia-sedation