Evaluation of the Efficacy of VR on Pain and Anxiety When Performing an Ultrasound-controlled Ankle Block.

NCT03677323 | Completed

• 1 other identifier: LOCAL2017-TP02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to observe or not a reduction on pain and anxiety felt by the patient when performing an ultrasound-controlled ankle block in preparation for forefoot surgery, using a virtual reality device instead of drug sedation.

Conditions

Hallux Valgus; Surgery

Keywords

virtual reality; pain; anxiety

Outcome Measures

Primary Outcomes (2)

• Digital visual scale to assess pain of patients during the treatment

  Numeric scale numbered from 0 to 10. 0: no pain 10 : worst possible pain

  5 min after the first nerve punction

• Digital visual scale to assess anxiety of patients during the treatment

  Numeric scale numbered from 0 to 10. 0: no anxiety 10 : worst possible anxiety

  5 min after the first nerve punction

Secondary Outcomes (2)

• Patient satisfaction questionnaire

  5 min after the last nerve punction

• Patient comfort assessment questionnaire

  5 min after the last nerve punction

Study Arms (2)

Virtual reality

EXPERIMENTAL

The virtual reality device will consist of the virtual reality headset and headphones for full immersion.

Device: Virtual reality

Drug sedation

ACTIVE COMPARATOR

The sedation group will benefit from drug sedation used in current practice, that is to say an association of Sufentanil, Droleptan and Propofol.

Drug: Droleptan; Drug: Propofol; Drug: Sufentanyl

Interventions

Virtual reality DEVICE

The patient will have the choice between different environments and the use of this device will remain under the control of the medical team. The patient will wear the virtual reality device at the time of the completion of the ankle block and will remove it once the nerve puncture is complete.

Also known as: VR

Virtual reality

Droleptan DRUG

Venous administration of 1.25 mg of Droleptan

Also known as: Sedation

Drug sedation

Propofol DRUG

Venous administration of 20 mg of Propofol

Also known as: Sedation

Drug sedation

Sufentanyl DRUG

Venous administration of 5 μg of Sufentanyl.

Also known as: Sedation

Drug sedation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with medical insurance
• Major patient requiring a Hallux Valgus surgery
• Patient who received information about study and signes a consent to participate in the study

You may not qualify if:

• Minor patient
• Patient participating in another interventional study
• Patient refusing to sign the consent form
• Patient for whom it is impossible to give informed information
• Patient who had previously undergone forefoot surgery under locoregional anesthesia
• Patient with poor skin condition or infection at puncture sites
• Patient refusing locoregional anesthesia
• Patient under the protection of justice, under curatorship or under tutorship
• Patient undergoing anxiolytic or antidepressant treatment
• Photosensitive epileptic patient

Sponsors & Collaborators

• Clinique Saint Jean, France: lead

Study Sites (1)

Clinique Saint Jean

Montpellier, 34090, France

Location

Related Publications (7)

• Mosso JL, Gorini A, De La Cerda G, Obrador T, Almazan A, Mosso D, Nieto JJ, Riva G. Virtual reality on mobile phones to reduce anxiety in outpatient surgery. Stud Health Technol Inform. 2009;142:195-200.

  PMID: 19377147 BACKGROUND

• Furman E, Jasinevicius TR, Bissada NF, Victoroff KZ, Skillicorn R, Buchner M. Virtual reality distraction for pain control during periodontal scaling and root planing procedures. J Am Dent Assoc. 2009 Dec;140(12):1508-16. doi: 10.14219/jada.archive.2009.0102.

  PMID: 19955069 BACKGROUND

• Patterson DR, Jensen MP, Wiechman SA, Sharar SR. Virtual reality hypnosis for pain associated with recovery from physical trauma. Int J Clin Exp Hypn. 2010 Jul;58(3):288-300. doi: 10.1080/00207141003760595.

  PMID: 20509069 BACKGROUND

• Nilsson S, Finnstrom B, Kokinsky E, Enskar K. The use of Virtual Reality for needle-related procedural pain and distress in children and adolescents in a paediatric oncology unit. Eur J Oncol Nurs. 2009 Apr;13(2):102-9. doi: 10.1016/j.ejon.2009.01.003. Epub 2009 Feb 20.

  PMID: 19230769 BACKGROUND

• Konstantatos AH, Angliss M, Costello V, Cleland H, Stafrace S. Predicting the effectiveness of virtual reality relaxation on pain and anxiety when added to PCA morphine in patients having burns dressings changes. Burns. 2009 Jun;35(4):491-9. doi: 10.1016/j.burns.2008.08.017. Epub 2008 Dec 27.

  PMID: 19111995 BACKGROUND

• Wright JL, Hoffman HG, Sweet RM. Virtual reality as an adjunctive pain control during transurethral microwave thermotherapy. Urology. 2005 Dec;66(6):1320. doi: 10.1016/j.urology.2005.06.123.

  PMID: 16360473 BACKGROUND

• Burt DE. Virtual reality in anaesthesia. Br J Anaesth. 1995 Oct;75(4):472-80. doi: 10.1093/bja/75.4.472. No abstract available.

  PMID: 7488491 BACKGROUND

MeSH Terms

Conditions

Hallux Valgus; Pain; Anxiety Disorders

Interventions

Droperidol; Propofol; Sufentanil

Condition Hierarchy (Ancestors)

Foot Deformities; Musculoskeletal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Butyrophenones; Ketones; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Thomas PILLANT, MD

  Clinique Saint Jean, Montpellier

  PRINCIPAL INVESTIGATOR

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: September 13, 2018
• First Posted: September 19, 2018
• Study Start: January 2, 2019
• Primary Completion: February 21, 2019
• Study Completion: February 21, 2019
• Last Updated: March 26, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)