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

Shoulder Dislocation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05388942
• Other study ID #: PT21134
• Status: Recruiting
• Phase: N/A
• Start date: October 9, 2022
• Est. completion date: January 9, 2024

Study information

• Verified date: February 2023
• Source: CHU de Reims
• Contact: Stéphane GENNAI
• Phone: 03 26 78 87 10
• Email: sgennai[@]chu-reims.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 126
• Est. completion date: January 9, 2024
• Est. primary completion date: October 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Shoulder Dislocation

Intervention

Procedure:
• 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.

Drug:
• Nitrous oxide
inhalation of NO usually used to help with ASD reduction but inhaled NO has safety and maintenance issues.

Locations

Country	Name	City	State
France	Damien JOLLY	Reims

Sponsors (1)

Lead Sponsor	Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of ASD procedure time		Day 0
Secondary	Achievement of the reduction of ASD procedure		Day 0
Secondary	Per-procedure pain	Visual analogue scale	Day 0
Secondary	Passage time in the ED		Day 0
Secondary	Patient satisfaction	Likert scale in 5 points	Day 0
Secondary	Adverse events when using HRV		Day 0
Secondary	Adverse events when using inhaled NO		Day 0