Virtual Reality Hypnosis Versus Inhaled Nitrous Oxide in Anterior Shoulder Dislocation Reduction: an Open Multicenter Randomized Controlled Trial
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|ClinicalTrials.gov Identifier: NCT05388942|
Recruitment Status : Not yet recruiting
First Posted : May 24, 2022
Last Update Posted : May 24, 2022
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||126 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|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.
- Reduction of ASD procedure time [ Time Frame: Day 0 ]
- Achievement of the reduction of ASD procedure [ Time Frame: Day 0 ]
- Per-procedure pain [ Time Frame: Day 0 ]Visual analogue scale
- Passage time in the ED [ Time Frame: Day 0 ]
- Patient satisfaction [ Time Frame: Day 0 ]Likert scale in 5 points
- Adverse events when using HRV [ Time Frame: Day 0 ]
- Adverse events when using inhaled NO [ Time Frame: Day 0 ]
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
|Contact: Stéphane GENNAI||03 26 78 87 10 ext email@example.com|
|Contact: Stéphanne GENNAI 03 26 78 87 10 ext 0033 firstname.lastname@example.org|