Pilot Study on the Evaluation of the Effectiveness of a Virtual Reality Device on Anxiety During Procedural Sedation in Traumatology in Emergency Department (VIRTUAL DREAM)

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 Overview

• Status: Completed
• Conditions: Fracture; Dislocation; Reality Device; Reduction Procedure
• Intervention / Treatment: Device: Experimental : Virtual reality + analgesia-sedation; Drug: Control: Analgesia-sedation

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sabrina SEGUIN, CRA; Phone Number: 0549443229; Email: sabrina.seguin@chu-poitiers.fr
• Study Contact Backup: Name: Alexandre RAHOUI, Hospital Practitioner; Phone Number: 46277 0549444444; Email: alexandre.rahoui@chu-poitiers.fr

Study Locations

• France
  • Poitiers, France, 86021
    • University Hospital of Poitiers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental : Virtual reality + analgesia-sedation; Use of a virtual reality device + analgesia-sedation drugs according to SFMU/SFAR 2010 guidelines during reduction procedure	Device: Experimental : Virtual reality + analgesia-sedation; Use of a virtual reality device + analgesia-sedation drugs according to SFMU/SFAR 2010 guidelines during reduction procedure
Active Comparator: Control: Analgesia-sedation; Use of analgesia-sedation drugs according to SFMU/SFAR 2010 guidelines during reduction procedure	Drug: Control: Analgesia-sedation; Use of analgesia-sedation drugs according to SFMU/SFAR 2010 guidelines during reduction procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in pain intensity	The level of pain is measured with a visual analog scale (0: no pain, 10: maximum pain).	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.	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.	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).	30 minutes

Collaborators and Investigators

• Sponsor: Poitiers University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2021
• Primary Completion (Actual): January 18, 2023
• Study Completion (Actual): January 18, 2023

Study Registration Dates

• First Submitted: June 16, 2021
• First Submitted That Met QC Criteria: June 16, 2021
• First Posted (Actual): June 23, 2021

Study Record Updates

• Last Update Posted (Actual): January 11, 2024
• Last Update Submitted That Met QC Criteria: January 10, 2024
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: VIRTUAL DREAM

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No