Pilot Study on the Evaluation of the Effectiveness of a Virtual Reality Device on Anxiety During Procedural Sedation in Traumatology in Emergency Department
NCT ID: NCT04936880
Last Updated: 2024-01-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2021-07-20
2023-01-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental : Virtual reality + analgesia-sedation
Use of a virtual reality device + analgesia-sedation drugs according to SFMU/SFAR 2010 guidelines during reduction procedure
Experimental : Virtual reality + analgesia-sedation
Use of a virtual reality device + analgesia-sedation drugs according to SFMU/SFAR 2010 guidelines during reduction procedure
Control: Analgesia-sedation
Use of analgesia-sedation drugs according to SFMU/SFAR 2010 guidelines during reduction procedure
Control: Analgesia-sedation
Use of analgesia-sedation drugs according to SFMU/SFAR 2010 guidelines during reduction procedure
Interventions
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Experimental : Virtual reality + analgesia-sedation
Use of a virtual reality device + analgesia-sedation drugs according to SFMU/SFAR 2010 guidelines during reduction procedure
Control: Analgesia-sedation
Use of analgesia-sedation drugs according to SFMU/SFAR 2010 guidelines during reduction procedure
Eligibility Criteria
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Inclusion Criteria
* Patient suffering from one of the following traumatic pathologies requiring a technical procedure in the emergency room Shoulder dislocation Ankle dislocation Elbow dislocation Wrist dislocation Reducible fractures
* No contraindication to Virtual Reality
* No contraindication to morphine, ketamine, propofol, paracetamol, nefopam and MEOPA
* Patient having given oral, free and informed consent
Exclusion Criteria
* Patient under the influence of alcohol or psychotropic drugs
* Patient presenting a psychosis and/or a state of agitation, and/or a state of confusion.
* Patient presenting a hemodynamic, respiratory or neurological failure
* Patient with at least one of the following symptoms at the time of inclusion in the study: headache, dizziness, nausea, vomiting
* Persons benefiting from reinforced protection, i.e. minors, persons deprived of their liberty by a judicial or administrative decision, adults under legal protection (guardianship and trusteeship) and finally patients in a vital emergency situation.
* Pregnant or breastfeeding women, women of childbearing age who do not have effective contraception (hormonal/mechanical: per os, injectable, transcutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total oophorectomy)
* Concurrent participation in another clinical research study whose objective is the evaluation of anxiety and/or pain
18 Years
ALL
No
Sponsors
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Poitiers University Hospital
OTHER
Responsible Party
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Locations
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University Hospital of Poitiers
Poitiers, , France
Countries
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Other Identifiers
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VIRTUAL DREAM
Identifier Type: -
Identifier Source: org_study_id
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