Reality DeviceVIRTUAL DREAMNCT04936880
Pilot Study on the Evaluation of the Effectiveness of a Virtual Reality Device on Anxiety During Procedural Sedation in Traumatology in Emergency Department
A study testing Experimental : Virtual reality + analgesia-sedation in people with Reality Device and Reduction Procedure, run by Poitiers University Hospital at 1 site in France.
Trial summary
The aim of this study is to evaluate the efficiency of a reality device and a virtual hypnosis software to reduce the anxiety during reduction procedure in traumatology in an emergency department. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Reality Device, Reduction Procedure, Fracture
- What is being tested?
- Experimental : Virtual reality + analgesia-sedation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jul 2021to 18 Jan 2023
- 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
- Patient aged 18 years or older
- 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
Who cannot join
- Patients suffering from mono or binocular blindness
- 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
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to evaluate the efficiency of a reality device and a virtual hypnosis software to reduce the anxiety during reduction procedure in traumatology in an emergency department. These devices have recently been evaluated in the management of pain and anxiety in different specialties but never in the context of analgesia-sedation protocols in emergencies.
- Conditions
- Reality Device, Reduction Procedure, Fracture, Dislocation
- Being tested
- Experimental : Virtual reality + analgesia-sedation, Control: Analgesia-sedation
- Medical subject headings
- Fractures, Bone, Joint Dislocations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental : Virtual reality + analgesia-sedationDevice
Use of a virtual reality device + analgesia-sedation drugs according to SFMU/SFAR 2010 guidelines during reduction procedure
Control: Analgesia-sedationDrug
Use of analgesia-sedation drugs according to SFMU/SFAR 2010 guidelines during reduction procedure
| Study group | Role | What they receive |
|---|---|---|
| Experimental : Virtual reality + analgesia-sedation | Experimental | Use of a virtual reality device + analgesia-sedation drugs according to SFMU/SFAR 2010 guidelines during reduction procedure Receives: Device: Experimental : Virtual reality + analgesia-sedation |
| Control: Analgesia-sedation | Active comparator | Use of analgesia-sedation drugs according to SFMU/SFAR 2010 guidelines during reduction procedure Receives: Drug: Control: Analgesia-sedation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in anxiety level
Difference in anxiety level measured with a visual analog scale between T1 (before the analgesia-sedation procedure) and T4 (30 minutes after the procedure was performed, by asking the patient to rate the anxiety he or she felt during the procedure) during a technical procedure in traumatology in the emergency department in the VR group compared with the control group.
The level of anxiety is measured with a visual analog scale (0: no anxiety, 10: maximum anxiety).
Measured: 30 minutes
Secondary outcomes (4)
Difference in pain intensity
The level of pain is measured with a visual analog scale (0: no pain, 10: maximum pain).
Measured: 30 minutes
Doses of analgesics
Total doses of analgesics used during a technical procedure performed in the context of trauma in the experimental group compared with the control group.
Measured: During the procedure
Occurrence of headache, nausea/vomiting, dizziness or confusional episode
Tolerance assessed by looking for the occurrence of headache, nausea/vomiting, dizziness or confusional episode in both groups.
Measured: During the procedure
Evaluation of satisfaction
Comparison of the patient's level of satisfaction with pain and anxiety management between the two groups, assessed using a numerical scale ranging from 0 (not satisfied) to 10 (totally satisfied).
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start20 Jul 2021
- Primary completion18 Jan 2023
- Study completion18 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reality DeviceStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04936880
- Sponsor's protocol ID
- VIRTUAL DREAM
- Acronym
- VIRTUAL DREAM
- Status last verified
- Jan 2023
- First submitted
- 16 Jun 2021
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on the Evaluation of the Effectiveness of a Virtual Reality Device on Anxiety During Procedural Sedation in Traumatology in Emergency Department
- ClinicalTrials.gov ID
- NCT04936880
- Acronym / sponsor ID
- VIRTUAL DREAM / VIRTUAL DREAM
- Conditions
- Reality Device, Reduction Procedure, Fracture, Dislocation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 20 Jul 2021 (actual)
- Primary completion
- 18 Jan 2023 (actual)
- Study completion
- 18 Jan 2023 (actual)
- First posted
- 23 Jun 2021 (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.
The aim of this study is to evaluate the efficiency of a reality device and a virtual hypnosis software to reduce the anxiety during reduction procedure in traumatology in an emergency department. These devices have recently been evaluated in the management of pain and anxiety in different specialties but never in the context of analgesia-sedation protocols in emergencies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental : Virtual reality + analgesia-sedation | Experimental | Device: Experimental : Virtual reality + analgesia-sedationUse of a virtual reality device + analgesia-sedation drugs according to SFMU/SFAR 2010 guidelines during reduction procedure |
| Control: Analgesia-sedation | Active comparator | Drug: Control: Analgesia-sedationUse of analgesia-sedation drugs according to SFMU/SFAR 2010 guidelines during reduction procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient aged 18 years or older
- 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
Key exclusion criteria (8 listed)
- Patients suffering from mono or binocular blindness
- 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
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 |
|---|---|---|
| Experimental : Virtual reality + analgesia-sedationUse of a virtual reality device + analgesia-sedation drugs according to SFMU/SFAR 2010 guidelines during reduction procedure | Device | Experimental : Virtual reality + analgesia-sedation |
| Control: Analgesia-sedationUse of analgesia-sedation drugs according to SFMU/SFAR 2010 guidelines during reduction procedure | Drug | Control: Analgesia-sedation |
Primary outcome
Difference in anxiety level
Time frame: 30 minutes
Difference in anxiety level measured with a visual analog scale between T1 (before the analgesia-sedation procedure) and T4 (30 minutes after the procedure was performed, by asking the patient to rate the anxiety he or she felt during the procedure) during a technical procedure in traumatology in the emergency department in the VR group compared with the control group. The level of anxiety is measured with a visual analog scale (0: no anxiety, 10: maximum anxiety).
4 secondary outcomes
Difference in pain intensity
Time frame: 30 minutes
Doses of analgesics
Time frame: During the procedure
Occurrence of headache, nausea/vomiting, dizziness or confusional episode
Time frame: During the procedure
Evaluation of satisfaction
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental : Virtual reality + analgesia-sedation in people with Reality Device and Reduction Procedure, run by Poitiers University Hospital 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 5 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: finished, as of the sponsor's last update on 11 Jan 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in anxiety level (time frame: 30 minutes). 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 11 Jan 2024.