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Completed

NCT Number: NCT04936880

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

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.

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Key information

Conditions

Reality Device Dislocation Fracture Fractures, Bone Joint Diseases Joint Dislocations Musculoskeletal Diseases Reduction Procedure Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Poitiers

Poitiers, 86021, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Experimental : Virtual reality + analgesia-sedation

Device

Use of a virtual reality device + analgesia-sedation drugs according to SFMU/SFAR 2010 guidelines during reduction procedure

Control: Analgesia-sedation

Drug

Use of analgesia-sedation drugs according to SFMU/SFAR 2010 guidelines during reduction procedure

Primary outcomes

  1. 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 outcomes

  1. 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).

  2. 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.

  3. 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.

  4. 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).

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Acronym: VIRTUAL DREAM

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 23, 2021
Registry last updated
Jan 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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