Clinical trial NCT04936880: Pilot Study on the Evaluation of the Effectiveness of a Virtual Reality Device on Anxiety During Procedural Sedation in Traumatology in Emergency Department
Official title: Pilot Study on the Evaluation of the Effectiveness of a Virtual Reality Device on Anxiety During Procedural Sedation in Traumatology in Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Reality Device
Reduction Procedure
Fracture
Dislocation
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2021-06-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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

Primary outcomes:
measure: Difference in anxiety level
timeFrame: 30 minutes
Secondary outcomes:
measure: Difference in pain intensity
timeFrame: 30 minutes
measure: Doses of analgesics
timeFrame: During the procedure
measure: Occurrence of headache, nausea/vomiting, dizziness or confusional episode
timeFrame: During the procedure
measure: Evaluation of satisfaction
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Poitiers
country: France
facility: University Hospital of Poitiers
Study officials:
References: