NCT04936880

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 23, 2021

Completed
27 days until next milestone

Study Start

First participant enrolled

July 20, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2023

Completed
Last Updated

January 11, 2024

Status Verified

January 1, 2023

Enrollment Period

1.5 years

First QC Date

June 16, 2021

Last Update Submit

January 10, 2024

Conditions

Reality DeviceReduction ProcedureFractureDislocation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Difference in pain intensity

    30 minutes

  • Doses of analgesics

    During the procedure

  • Occurrence of headache, nausea/vomiting, dizziness or confusional episode

    During the procedure

  • Evaluation of satisfaction

    30 minutes

Study Arms (2)

Experimental : Virtual reality + analgesia-sedation

EXPERIMENTAL

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

Device: Experimental : Virtual reality + analgesia-sedation

Control: Analgesia-sedation

ACTIVE COMPARATOR

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

Drug: Control: Analgesia-sedation

Interventions

Experimental : Virtual reality + analgesia-sedationDEVICE

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

Experimental : Virtual reality + analgesia-sedation
Control: Analgesia-sedationDRUG

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

Control: Analgesia-sedation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Poitiers

Poitiers, 86021, France

Location

MeSH Terms

Conditions

Fractures, BoneJoint Dislocations

Condition Hierarchy (Ancestors)

Wounds and InjuriesJoint DiseasesMusculoskeletal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2021

First Posted

June 23, 2021

Study Start

July 20, 2021

Primary Completion

January 18, 2023

Study Completion

January 18, 2023

Last Updated

January 11, 2024

Record last verified: 2023-01

Locations

FR(1)