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

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 1, 2022

Interventions

  • Device: Experimental : Virtual reality + analgesia-sedation
    • Use of a virtual reality device + 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

Arms, Groups and Cohorts

  • Experimental: 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

Clinical Trial Outcome Measures

Primary Measures

  • 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).

Secondary Measures

  • Difference in pain intensity
    • Time Frame: 30 minutes
    • The level of pain is measured with a visual analog scale (0: no pain, 10: maximum pain).
  • Doses of analgesics
    • Time Frame: During the procedure
    • 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
    • Time Frame: During the procedure
    • Tolerance assessed by looking for the occurrence of headache, nausea/vomiting, dizziness or confusional episode in both groups.
  • Evaluation of satisfaction
    • Time Frame: 30 minutes
    • 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).

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Poitiers University Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Alexandre RAHOUI, Hospital Practitioner, 0549444444, alexandre.rahoui@chu-poitiers.fr

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