Hallux Valgus, Surgery
Conditions
Keywords
virtual reality, pain, anxiety
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.
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.
Interventions
DEVICEVirtual 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.
DRUGDroleptan
Venous administration of 1.25 mg of Droleptan
DRUGPropofol
Venous administration of 20 mg of Propofol
DRUGSufentanyl
Venous administration of 5 μg of Sufentanyl.
Sponsors
Clinique Saint Jean, France
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Digital visual scale to assess pain of patients during the treatment | 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 | 5 min after the first nerve punction | Numeric scale numbered from 0 to 10. 0: no anxiety 10 : worst possible anxiety |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction questionnaire | 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 | 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 |
Countries
France
Outcome results
None listed