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Completed

NCT Number: NCT03677323

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique Saint Jean

Montpellier, 34090, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

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.

Other names: VR

Droleptan

Drug

Venous administration of 1.25 mg of Droleptan

Other names: Sedation

Propofol

Drug

Venous administration of 20 mg of Propofol

Other names: Sedation

Sufentanyl

Drug

Venous administration of 5 μg of Sufentanyl.

Other names: Sedation

Primary outcomes

  1. 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

  2. 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 outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Clinique Saint Jean, France

Other

Registry information

Acronym: VRBLOC

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 19, 2018
Registry last updated
Mar 26, 2019

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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