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

NCT ID: NCT05388942

Last Updated: 2023-02-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-09
• Study Completion Date: 2024-01-09

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Virtual reality hypnosis (VRH)

Group Type: EXPERIMENTAL

Virtual reality hypnosis

Intervention Type: 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.

Nitrous oxide (NO)

Group Type: ACTIVE_COMPARATOR

Nitrous oxide

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: PROCEDURE

Nitrous oxide

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CHU de Reims

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Damien JOLLY

Reims, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Stéphane GENNAI

Role: CONTACT

sgennai@chu-reims.fr

03 26 78 87 10 ext. 0033

Facility Contacts

Stéphanne GENNAI

Role: primary

sgennai@chu-reims.fr

03 26 78 87 10 ext. 0033

Other Identifiers

PT21134

Identifier Type: -

Identifier Source: org_study_id