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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 21, 2019

Detailed Description

Currently, in preparation for forefoot surgery, the realization of the ankle block is accompanied by drug sedation. The investigator's randomized study aims to compare the anxiety and pain experienced by patients who have benefited from drug sedation with those of patients who benefited from the virtual reality device at the time of the realization of the ankle block.

Interventions

  • Device: Virtual reality
    • 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.
  • Drug: Droleptan
    • Venous administration of 1.25 mg of Droleptan
  • Drug: Propofol
    • Venous administration of 20 mg of Propofol
  • Drug: Sufentanyl
    • Venous administration of 5 μg of Sufentanyl.

Arms, Groups and Cohorts

  • Experimental: Virtual reality
    • The virtual reality device will consist of the virtual reality headset and headphones for full immersion.
  • Active Comparator: Drug sedation
    • The sedation group will benefit from drug sedation used in current practice, that is to say an association of Sufentanil, Droleptan and Propofol.

Clinical Trial Outcome Measures

Primary Measures

  • Digital visual scale to assess pain of patients during the treatment
    • Time Frame: 5 min after the first nerve punction
    • Numeric scale numbered from 0 to 10. 0: no pain 10 : worst possible pain
  • Digital visual scale to assess anxiety of patients during the treatment
    • Time Frame: 5 min after the first nerve punction
    • Numeric scale numbered from 0 to 10. 0: no anxiety 10 : worst possible anxiety

Secondary Measures

  • Patient satisfaction questionnaire
    • Time Frame: 5 min after the last nerve punction
    • Concerns all patients Numeric scale numbered from 0 to 10. 0: unsatisfied 10 : very satisfied
  • Patient comfort assessment questionnaire
    • Time Frame: 5 min after the last nerve punction
    • Concerns all patients. This is a question to determine their comfort levels during the experiment. Numeric scale numbered from 1 to 5. : very comfortable : comfortable : less comfortable : uncomfortable : very uncomfortable

Participating in This Clinical Trial

Inclusion Criteria

  • 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 Exclusion Criteria:

  • 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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Clinique Saint Jean, France
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Thomas PILLANT, MD, Principal Investigator, Clinique Saint Jean, Montpellier

References

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.

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.

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.

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.

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.

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.

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.

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