Shoulder Dislocation
Conditions
Keywords
shoulder dislocation, virtual reality, hypnosis
Brief summary
Anterior shoulder dislocation (ASD) is a common situation in the emergency department (ED). Quick reductions lead to reduced mid and long term complications. No technique is superior to one another. Inhaled nitrous oxide can deal with pain reduction and anxiety but its efficacy is not optimal, with safety issues. Virtual reality hypnosis (VRH), by distracting patients from their pain, may lead to a better muscular relaxation and an easier ASD reduction. Our first objective is to evaluate the clinical interest of VHR compared to nitrous oxide, in ASD reduction. Our second objective is to evaluate the safety of VRH in ASD reduction. Patients over 18 years presenting an ASD \< 24 hours, will be illegible for enrollment in an open multicenter randomized controlled trial, conducted in the Great East Region in France.
Interventions
PROCEDUREVirtual reality hypnosis
VRH offers predefined hypnosis sessions with no need of trained physician or nurse or caregiver mobilization. Consisting of a headset including headphones and a virtual reality screen, VRH allow patients to select a visual and sound environment (e.g.: tropical beach, space, underwater…) into which the hypnotic speech is delivered. That way, the patient's attention is distracted and muscular relaxation is obtained, a major relaxation factor. HRV is simple, quick, and presumably safe.
DRUGNitrous oxide
inhalation of NO usually used to help with ASD reduction but inhaled NO has safety and maintenance issues.
Sponsors
CHU de Reims
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients of 18 years and older * consulting the ED for a ASD \< 24 hours * with or without history of ASD * with social insurance
Exclusion criteria
* non anterior shoulder dislocation * shoulder or facial fracture or multiple trauma patient * dementia, psychosis * uncontrolled epilepsy * visual or hearing issues * claustrophobia * vascular or nervous lesion of the dislocated arm * contraindication with the use of inhaled nitrous oxide
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of ASD procedure time | Day 0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Per-procedure pain | Day 0 | Visual analogue scale |
| Passage time in the ED | Day 0 | — |
| Achievement of the reduction of ASD procedure | Day 0 | — |
| Adverse events when using HRV | Day 0 | — |
| Adverse events when using inhaled NO | Day 0 | — |
| Patient satisfaction | Day 0 | Likert scale in 5 points |
Countries
France
Contacts
Primary ContactStéphane GENNAI
Outcome results
None listed