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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Surgery, Hallux Valgus

Intervention / Treatment
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* Device: Virtual reality
* Drug: Droleptan
* Drug: Propofol
* Drug: Sufentanyl


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual reality<br>The virtual reality device will consist of the virtual reality headset and headphones for full immersion. | Device: Virtual reality<br>* 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.<br>* Other names: VR;|
| Active Comparator: Drug sedation<br>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<br>* Venous administration of 1.25 mg of Droleptan<br>* Other names: Sedation;Drug: Propofol<br>* Venous administration of 20 mg of Propofol<br>* Other names: Sedation;Drug: Sufentanyl<br>* Venous administration of 5 μg of Sufentanyl.<br>* Other names: Sedation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Digital visual scale to assess pain of patients during the treatment | 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 | 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 | 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 | 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 | 5 min after the last nerve punction | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anxiety, virtual reality, pain