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

Primary Purpose

Shoulder Dislocation

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Virtual reality hypnosis
Nitrous oxide
Sponsored by
CHU de Reims
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Shoulder Dislocation focused on measuring shoulder dislocation, virtual reality, hypnosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Damien JOLLYRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Virtual reality hypnosis (VRH)

Nitrous oxide (NO)

Arm Description

Outcomes

Primary Outcome Measures

Reduction of ASD procedure time

Secondary Outcome Measures

Achievement of the reduction of ASD procedure
Per-procedure pain
Visual analogue scale
Passage time in the ED
Patient satisfaction
Likert scale in 5 points
Adverse events when using HRV
Adverse events when using inhaled NO

Full Information

First Posted
May 19, 2022
Last Updated
February 22, 2023
Sponsor
CHU de Reims
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1. Study Identification

Unique Protocol Identification Number
NCT05388942
Brief Title
Virtual Reality Hypnosis Versus Inhaled Nitrous Oxide in Anterior Shoulder Dislocation Reduction: an Open Multicenter Randomized Controlled Trial
Official Title
Virtual Reality Hypnosis Versus Inhaled Nitrous Oxide to Reduce Anterior Shoulder Dislocations: an Open Multicenter Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 9, 2022 (Actual)
Primary Completion Date
October 9, 2023 (Anticipated)
Study Completion Date
January 9, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Reims

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Dislocation
Keywords
shoulder dislocation, virtual reality, hypnosis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
126 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Virtual reality hypnosis (VRH)
Arm Type
Experimental
Arm Title
Nitrous oxide (NO)
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Virtual reality hypnosis
Intervention Description
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
Drug
Intervention Name(s)
Nitrous oxide
Intervention Description
inhalation of NO usually used to help with ASD reduction but inhaled NO has safety and maintenance issues.
Primary Outcome Measure Information:
Title
Reduction of ASD procedure time
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Achievement of the reduction of ASD procedure
Time Frame
Day 0
Title
Per-procedure pain
Description
Visual analogue scale
Time Frame
Day 0
Title
Passage time in the ED
Time Frame
Day 0
Title
Patient satisfaction
Description
Likert scale in 5 points
Time Frame
Day 0
Title
Adverse events when using HRV
Time Frame
Day 0
Title
Adverse events when using inhaled NO
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stéphane GENNAI
Phone
03 26 78 87 10
Ext
0033
Email
sgennai@chu-reims.fr
Facility Information:
Facility Name
Damien JOLLY
City
Reims
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphanne GENNAI
Phone
03 26 78 87 10
Ext
0033
Email
sgennai@chu-reims.fr

12. IPD Sharing Statement

Learn more about this trial

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

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