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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05388942
Recruitment Status : Not yet recruiting
First Posted : May 24, 2022
Last Update Posted : May 24, 2022
Sponsor:
Information provided by (Responsible Party):
CHU de Reims

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : November 2022
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : February 2024

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Reduction of ASD procedure time [ Time Frame: Day 0 ]

Secondary Outcome Measures :
  1. Achievement of the reduction of ASD procedure [ Time Frame: Day 0 ]
  2. Per-procedure pain [ Time Frame: Day 0 ]
    Visual analogue scale

  3. Passage time in the ED [ Time Frame: Day 0 ]
  4. Patient satisfaction [ Time Frame: Day 0 ]
    Likert scale in 5 points

  5. Adverse events when using HRV [ Time Frame: Day 0 ]
  6. Adverse events when using inhaled NO [ Time Frame: Day 0 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05388942


Contacts
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Contact: Stéphane GENNAI 03 26 78 87 10 ext 0033 sgennai@chu-reims.fr

Locations
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France
Damien JOLLY
Reims, France
Contact: Stéphanne GENNAI    03 26 78 87 10 ext 0033    sgennai@chu-reims.fr   
Sponsors and Collaborators
CHU de Reims
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Responsible Party: CHU de Reims
ClinicalTrials.gov Identifier: NCT05388942    
Other Study ID Numbers: PT21134
First Posted: May 24, 2022    Key Record Dates
Last Update Posted: May 24, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CHU de Reims:
shoulder dislocation
virtual reality
hypnosis
Additional relevant MeSH terms:
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Joint Dislocations
Shoulder Dislocation
Joint Diseases
Musculoskeletal Diseases
Wounds and Injuries
Shoulder Injuries
Nitrous Oxide
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents