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

Not Applicable

Recruiting

• Conditions: Shoulder Dislocation
• Interventions: Procedure: Virtual reality hypnosis; Drug: Nitrous oxide

• Registration Number: NCT05388942
• Lead Sponsor: CHU de Reims

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-19
• Study First Submitted QC: 2022-05-19
• Study First Posted: 2022-05-24
• Study Start: 2022-10-09
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-22
• Last Update Posted: 2023-02-23
• Primary Completion: 2023-10-09
• Study Completion: 2024-01-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 126

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual reality hypnosis (VRH)	Virtual reality hypnosis	-
Nitrous oxide (NO)	Nitrous oxide	-

Primary Outcome Measures

Name	Time	Method
Reduction of ASD procedure time	Day 0

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Damien JOLLY; 🇫🇷 Reims, France