Virtual Reality Hypnosis Versus Inhaled Nitrous Oxide in Anterior Shoulder Dislocation Reduction: an Open Multicenter Randomized Controlled Trial

Study Overview
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Brief Summary
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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.

Official Title
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Virtual Reality Hypnosis Versus Inhaled Nitrous Oxide to Reduce Anterior Shoulder Dislocations: an Open Multicenter Randomized Controlled Trial

Conditions
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Shoulder Dislocation

Intervention / Treatment
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* Procedure: Virtual reality hypnosis
* Drug: Nitrous oxide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual reality hypnosis (VRH)<br> | Procedure: Virtual reality hypnosis<br>* 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.<br>|
| Active Comparator: Nitrous oxide (NO)<br> | Drug: Nitrous oxide<br>* inhalation of NO usually used to help with ASD reduction but inhaled NO has safety and maintenance issues.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of ASD procedure time |  | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achievement of the reduction of ASD procedure |  | Day 0 | 
| Per-procedure pain | Visual analogue scale | Day 0 | 
| Passage time in the ED |  | Day 0 | 
| Patient satisfaction | Likert scale in 5 points | Day 0 | 
| Adverse events when using HRV |  | Day 0 | 
| Adverse events when using inhaled NO |  | Day 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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shoulder dislocation, virtual reality, hypnosis