Clinique Saint Jean
Montpellier, 34090, France
NCT Number: NCT03677323
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Montpellier, 34090, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Venous administration of 1.25 mg of Droleptan
Other names: Sedation
Venous administration of 20 mg of Propofol
Other names: Sedation
Venous administration of 5 μg of Sufentanyl.
Other names: Sedation
Time frame: 5 min after the first nerve punction
Numeric scale numbered from 0 to 10. 0: no pain 10 : worst possible pain
Time frame: 5 min after the first nerve punction
Numeric scale numbered from 0 to 10. 0: no anxiety 10 : worst possible anxiety
Time frame: 5 min after the last nerve punction
Concerns all patients Numeric scale numbered from 0 to 10. 0: unsatisfied 10 : very satisfied
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.
Clinique Saint Jean, France
Other
Acronym: VRBLOC
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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