Evaluation of the Efficacy of VR on Pain and Anxiety When Performing an Ultrasound-controlled Ankle Block. (VRBLOC)
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ClinicalTrials.gov Identifier: NCT03677323 |
Recruitment Status :
Completed
First Posted : September 19, 2018
Last Update Posted : March 26, 2019
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Condition or disease | Intervention/treatment | Phase |
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Hallux Valgus Surgery | Device: Virtual reality Drug: Droleptan Drug: Propofol Drug: Sufentanyl | Not Applicable |
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 (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 |

Arm | Intervention/treatment |
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Experimental: Virtual reality
The virtual reality device will consist of the virtual reality headset and headphones for full immersion.
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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.
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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 |
- 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
- 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

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

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
France | |
Clinique Saint Jean | |
Montpellier, France, 34090 |
Principal Investigator: | Thomas PILLANT, MD | Clinique Saint Jean, Montpellier |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
virtual reality pain anxiety |
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 |