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

March 25, 2019 updated by: Clinique Saint Jean, France
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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34090
        • Clinique Saint Jean

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Virtual reality
The virtual reality device will consist of the virtual reality headset and headphones for full immersion.
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.

Other Names:
  • VR
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.
Drug: Droleptan
Venous administration of 1.25 mg of Droleptan
Other Names:
  • Sedation
Drug: Propofol
Venous administration of 20 mg of Propofol
Other Names:
  • Sedation
Drug: Sufentanyl
Venous administration of 5 μg of Sufentanyl.
Other Names:
  • Sedation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 min after the first nerve punction
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
5 min after the first nerve punction

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 min after the last nerve punction
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.

  1. : very comfortable
  2. : comfortable
  3. : less comfortable
  4. : uncomfortable
  5. : very uncomfortable
5 min after the last nerve punction

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinique Saint Jean, France

Investigators

  • Principal Investigator: Thomas PILLANT, MD, Clinique Saint Jean, Montpellier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2019

Primary Completion (Actual)

February 21, 2019

Study Completion (Actual)

February 21, 2019

Study Registration Dates

First Submitted

September 13, 2018

First Submitted That Met QC Criteria

September 18, 2018

First Posted (Actual)

September 19, 2018

Study Record Updates

Last Update Posted (Actual)

March 26, 2019

Last Update Submitted That Met QC Criteria

March 25, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LOCAL2017-TP02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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