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

Not Applicable

Completed

• Conditions: Reduction Procedure; Fracture; Dislocation; Reality Device

• Registration Number: NCT04936880
• Lead Sponsor: Poitiers University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-16
• Study First Submitted QC: 2021-06-16
• Study First Posted: 2021-06-23
• Study Start: 2021-07-20
• Status Verified: 2023-01
• Primary Completion: 2023-01-18
• Study Completion: 2023-01-18
• Last Update Submitted: 2024-01-10
• Last Update Posted: 2024-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Difference in anxiety level	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 Outcome Measures

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

Trial Locations

Locations (1)

University Hospital of Poitiers; 🇫🇷 Poitiers, France