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

February 22, 2023 updated by: CHU de Reims

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

126

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Reims, France
        • Recruiting
        • Damien JOLLY
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction of ASD procedure time
Time Frame: Day 0
Day 0

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHU de Reims

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 9, 2022

Primary Completion (Anticipated)

October 9, 2023

Study Completion (Anticipated)

January 9, 2024

Study Registration Dates

First Submitted

May 19, 2022

First Submitted That Met QC Criteria

May 19, 2022

First Posted (Actual)

May 24, 2022

Study Record Updates

Last Update Posted (Estimate)

February 23, 2023

Last Update Submitted That Met QC Criteria

February 22, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PT21134

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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