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

Fracture Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04936880
• Other study ID #: VIRTUAL DREAM
• Status: Completed
• Phase: N/A
• Start date: July 20, 2021
• Est. completion date: January 18, 2023

Study information

• Verified date: January 2023
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 18, 2023
• Est. primary completion date: January 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dislocation
• Emergencies
• Fracture

Intervention

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

Locations

Country	Name	City	State
France	University Hospital of Poitiers	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Difference in pain intensity	The level of pain is measured with a visual analog scale (0: no pain, 10: maximum pain).	30 minutes
Secondary	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
Secondary	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
Secondary	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