Clinical trial
Virtual Reality Hypnosis Versus Inhaled Nitrous Oxide to Reduce Anterior Shoulder Dislocations: an Open Multicenter Randomized Controlled Trial
Name
PT21134
Description
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.
Trial arms
Trial start
2022-10-09
Estimated PCD
2023-10-09
Trial end
2024-01-09
Status
Recruiting
Treatment
Virtual 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.
Arms:
Virtual reality hypnosis (VRH)
Nitrous oxide
inhalation of NO usually used to help with ASD reduction but inhaled NO has safety and maintenance issues.
Arms:
Nitrous oxide (NO)
Size
126
Primary endpoint
Reduction of ASD procedure time
Day 0
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 126, 'type': 'ESTIMATED'}}
Updated at
2023-02-23
1 organization
Organization
Centre hospitalier universitaire de Reims