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

CHU de Reims

Status: Enrolling

Conditions: Shoulder Dislocation

Treatments: Drug: Nitrous oxide; Procedure: Virtual reality hypnosis

Study type: Interventional

Funder types: Other

Identifiers

NCT05388942

PT21134

Details and patient eligibility

About

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.

Enrollment: 126 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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126 participants in 2 patient groups

Virtual reality hypnosis (VRH)

Experimental group

Treatment:

Procedure: Virtual reality hypnosis

Nitrous oxide (NO)

Active Comparator group

Treatment:

Drug: Nitrous oxide