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

Sponsor

CHU de Reims (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05388942

Collaborator

(none)

126

Enrollment

Location

Arms

Anticipated Duration (Months)

8.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Shoulder Dislocation	Procedure: Virtual reality hypnosis Drug: Nitrous oxide	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

126 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2022

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Feb 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Virtual reality hypnosis (VRH)	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.
Active Comparator: Nitrous oxide (NO)	Drug: Nitrous oxide inhalation of NO usually used to help with ASD reduction but inhaled NO has safety and maintenance issues.

Arm

Intervention/Treatment

Experimental: Virtual reality hypnosis (VRH)

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.

Active Comparator: Nitrous oxide (NO)

Drug: Nitrous oxide

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

Outcome Measures

Primary Outcome Measures

Reduction of ASD procedure time [Day 0]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Damien JOLLY	Reims		France

Sponsors and Collaborators

CHU de Reims

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

CHU de Reims

ClinicalTrials.gov Identifier:

NCT05388942

Other Study ID Numbers:

PT21134

First Posted:

May 24, 2022

Last Update Posted:

May 24, 2022

Last Verified:

May 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by CHU de Reims

shoulder dislocation

virtual reality

hypnosis

Additional relevant MeSH terms:

Joint Dislocations

Shoulder Dislocation

Nitrous Oxide

Study Results

No Results Posted as of May 24, 2022