Shoulder DislocationNCT05388942
Virtual Reality Hypnosis Versus Inhaled Nitrous Oxide in Anterior Shoulder Dislocation Reduction: an Open Multicenter Randomized Controlled Trial
A study testing Virtual reality hypnosis and Nitrous oxide in people with Shoulder Dislocation, run by CHU de Reims at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Dislocation
- What is being tested?
- Virtual reality hypnosis and Nitrous oxide
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteFrance
- Study dates
- 9 Oct 2022to 9 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients of 18 years and older
- consulting the ED for a ASD < 24 hours
- with or without history of ASD
- with social insurance
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Damien JOLLY
Reims
Stéphanne GENNAI, 03 26 78 87 10 ext. 0033, sgennai@chu-reims.fr
About this study
Official title: 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.
- Conditions
- Shoulder Dislocation
- Being tested
- Virtual reality hypnosis, Nitrous oxide
- Keywords
- shoulder dislocation, virtual reality, hypnosis
- Medical subject headings
- Shoulder Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality hypnosisProcedure or surgery
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.
Nitrous oxideDrug
inhalation of NO usually used to help with ASD reduction but inhaled NO has safety and maintenance issues.
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality hypnosis (VRH) | Experimental | Not described Receives: Procedure: Virtual reality hypnosis |
| Nitrous oxide (NO) | Active comparator | Not described Receives: Drug: Nitrous oxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of ASD procedure time
Measured: Day 0
Secondary outcomes (6)
Achievement of the reduction of ASD procedure
Measured: Day 0
Per-procedure pain
Visual analogue scale
Measured: Day 0
Passage time in the ED
Measured: Day 0
Patient satisfaction
Likert scale in 5 points
Measured: Day 0
Adverse events when using HRV
Measured: Day 0
Adverse events when using inhaled NO
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start9 Oct 2022
- Primary completion9 Oct 2023 (estimated)
- Study completion9 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder DislocationStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05388942
- Sponsor's protocol ID
- PT21134
- Status last verified
- Feb 2023
- First submitted
- 19 May 2022
- Last updated
- 23 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Hypnosis Versus Inhaled Nitrous Oxide to Reduce Anterior Shoulder Dislocations: an Open Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05388942
- Acronym / sponsor ID
- PT21134
- Conditions
- Shoulder Dislocation
- Keywords
- shoulder dislocation, virtual reality, hypnosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 9 Oct 2022 (actual)
- Primary completion
- 9 Oct 2023 (estimated)
- Study completion
- 9 Jan 2024 (estimated)
- First posted
- 24 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual reality hypnosis (VRH) | Experimental | Procedure: Virtual reality hypnosis |
| Nitrous oxide (NO) | Active comparator | Drug: Nitrous oxide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients of 18 years and older
- consulting the ED for a ASD < 24 hours
- with or without history of ASD
- with social insurance
Key exclusion criteria (8 listed)
- non anterior shoulder dislocation
- shoulder or facial fracture or multiple trauma patient
- dementia, psychosis
- uncontrolled epilepsy
- visual or hearing issues
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality hypnosisVRH 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. | Procedure or surgery | Virtual reality hypnosis (VRH) |
| Nitrous oxideinhalation of NO usually used to help with ASD reduction but inhaled NO has safety and maintenance issues. | Drug | Nitrous oxide (NO) |
Primary outcome
Reduction of ASD procedure time
Time frame: Day 0
6 secondary outcomes
Achievement of the reduction of ASD procedure
Time frame: Day 0
Per-procedure pain
Time frame: Day 0
Passage time in the ED
Time frame: Day 0
Patient satisfaction
Time frame: Day 0
Adverse events when using HRV
Time frame: Day 0
Adverse events when using inhaled NO
Time frame: Day 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality hypnosis and Nitrous oxide in people with Shoulder Dislocation, run by CHU de Reims at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stéphane GENNAI (03 26 78 87 10 ext. 0033, sgennai@chu-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of ASD procedure time (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2023.