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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03677323
Recruitment Status : Completed
First Posted : September 19, 2018
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
Clinique Saint Jean, France

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.

Condition or disease Intervention/treatment Phase
Hallux Valgus Surgery Device: Virtual reality Drug: Droleptan Drug: Propofol Drug: Sufentanyl Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy of VR on Pain and Anxiety When Performing an Ultrasound-controlled Ankle Block.
Actual Study Start Date : January 2, 2019
Actual Primary Completion Date : February 21, 2019
Actual Study Completion Date : February 21, 2019

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Bunion
MedlinePlus related topics: Anxiety

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 Name: 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 Name: Sedation

Drug: Propofol
Venous administration of 20 mg of Propofol
Other Name: Sedation

Drug: Sufentanyl
Venous administration of 5 μg of Sufentanyl.
Other Name: Sedation




Primary Outcome Measures :
  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 Outcome Measures :
  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.

    1. : very comfortable
    2. : comfortable
    3. : less comfortable
    4. : uncomfortable
    5. : very uncomfortable



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03677323


Locations
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France
Clinique Saint Jean
Montpellier, France, 34090
Sponsors and Collaborators
Clinique Saint Jean, France
Investigators
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Principal Investigator: Thomas PILLANT, MD Clinique Saint Jean, Montpellier
Publications:
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Responsible Party: Clinique Saint Jean, France
ClinicalTrials.gov Identifier: NCT03677323    
Other Study ID Numbers: LOCAL2017-TP02
First Posted: September 19, 2018    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Clinique Saint Jean, France:
virtual reality
pain
anxiety
Additional relevant MeSH terms:
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Hallux Valgus
Foot Deformities
Musculoskeletal Diseases
Sufentanil
Droperidol
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Antiemetics
Autonomic Agents
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Psychotropic Drugs
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action