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

NCT05388942 | Unknown

• 1 other identifier: PT21134
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Dislocation

Keywords

shoulder dislocation; virtual reality; hypnosis

Outcome Measures

Primary Outcomes (1)

• Reduction of ASD procedure time

  Day 0

Secondary Outcomes (6)

• Achievement of the reduction of ASD procedure

  Day 0

• Per-procedure pain

  Day 0

• Passage time in the ED

  Day 0

• Patient satisfaction

  Day 0

• Adverse events when using HRV

  Day 0

Study Arms (2)

Virtual reality hypnosis (VRH)

EXPERIMENTAL

Procedure: Virtual reality hypnosis

Nitrous oxide (NO)

ACTIVE COMPARATOR

Drug: Nitrous oxide

Interventions

Virtual reality hypnosis PROCEDURE

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.

Virtual reality hypnosis (VRH)

Nitrous oxide DRUG

inhalation of NO usually used to help with ASD reduction but inhaled NO has safety and maintenance issues.

Nitrous oxide (NO)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients of 18 years and older
• consulting the ED for a ASD \< 24 hours
• with or without history of ASD
• with social insurance

You may not qualify if:

• 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

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Damien JOLLY

Reims, France

RECRUITING

MeSH Terms

Conditions

Shoulder Dislocation

Interventions

Nitrous Oxide

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Shoulder Injuries

Intervention Hierarchy (Ancestors)

Nitrogen Oxides; Gases; Inorganic Chemicals; Nitrogen Compounds; Oxides; Oxygen Compounds

Central Study Contacts

Stéphane GENNAI

CONTACT

03 26 78 87 10; sgennai@chu-reims.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2022
• First Posted: May 24, 2022
• Study Start: October 9, 2022
• Primary Completion: October 9, 2023
• Study Completion: January 9, 2024
• Last Updated: February 23, 2023

Record last verified: 2023-02

Locations

FR (1)