Back to resultsPilot Study on the Evaluation of the Effectiveness of a Virtual Reality Device on Anxiety During Procedural Sedation in Traumatology in Emergency Department (VIRTUAL DREAM)
Primary Purpose
Reality Device, Reduction Procedure, Fracture
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Experimental : Virtual reality + analgesia-sedation
Control: Analgesia-sedation
Sponsored by
About this trial
This is an interventional treatment trial for Reality Device
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- University Hospital of PoitiersRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental : Virtual reality + analgesia-sedation
Control: Analgesia-sedation
Arm Description
Use of a virtual reality device + analgesia-sedation drugs according to SFMU/SFAR 2010 guidelines during reduction procedure
Use of analgesia-sedation drugs according to SFMU/SFAR 2010 guidelines during reduction procedure
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Difference in pain intensity
The level of pain is measured with a visual analog scale (0: no pain, 10: maximum pain).
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.
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.
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).
Full Information
NCT ID
NCT04936880
First Posted
June 16, 2021
Last Updated
January 5, 2023
Sponsor
Poitiers University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04936880
Brief Title
Pilot Study on the Evaluation of the Effectiveness of a Virtual Reality Device on Anxiety During Procedural Sedation in Traumatology in Emergency Department
Acronym
VIRTUAL DREAM
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
May 1, 2023 (Anticipated)
Study Completion Date
May 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Reality Device, Reduction Procedure, Fracture, Dislocation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental : Virtual reality + analgesia-sedation
Arm Type
Experimental
Arm Description
Use of a virtual reality device + analgesia-sedation drugs according to SFMU/SFAR 2010 guidelines during reduction procedure
Arm Title
Control: Analgesia-sedation
Arm Type
Active Comparator
Arm Description
Use of analgesia-sedation drugs according to SFMU/SFAR 2010 guidelines during reduction procedure
Intervention Type
Device
Intervention Name(s)
Experimental : Virtual reality + analgesia-sedation
Intervention Description
Use of a virtual reality device + analgesia-sedation drugs according to SFMU/SFAR 2010 guidelines during reduction procedure
Intervention Type
Drug
Intervention Name(s)
Control: Analgesia-sedation
Intervention Description
Use of analgesia-sedation drugs according to SFMU/SFAR 2010 guidelines during reduction procedure
Primary Outcome Measure Information:
Title
Difference in anxiety level
Description
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).
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Difference in pain intensity
Description
The level of pain is measured with a visual analog scale (0: no pain, 10: maximum pain).
Time Frame
30 minutes
Title
Doses of analgesics
Description
Total doses of analgesics used during a technical procedure performed in the context of trauma in the experimental group compared with the control group.
Time Frame
During the procedure
Title
Occurrence of headache, nausea/vomiting, dizziness or confusional episode
Description
Tolerance assessed by looking for the occurrence of headache, nausea/vomiting, dizziness or confusional episode in both groups.
Time Frame
During the procedure
Title
Evaluation of satisfaction
Description
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).
Time Frame
30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandre RAHOUI, Hospital Practitioner
Phone
0549444444
Ext
46277
Email
alexandre.rahoui@chu-poitiers.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Sabrina SEGUIN, CRA
Phone
0549443229
Email
sabrina.seguin@chu-poitiers.fr
Facility Information:
Facility Name
University Hospital of Poitiers
City
Poitiers
ZIP/Postal Code
86021
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandre RAHOUI
Phone
0549444444
Ext
46277
Email
alexandre.rahoui@chu-poitiers.fr
First Name & Middle Initial & Last Name & Degree
Sabrina SEGUIN, CRA
Phone
0549443229
Email
sabrina.seguin@chu-poitiers.fr
12. IPD Sharing Statement
Learn more about this trial
Pilot Study on the Evaluation of the Effectiveness of a Virtual Reality Device on Anxiety During Procedural Sedation in Traumatology in Emergency Department
We'll reach out to this number within 24 hrs