Clinical Trials Directory

Trials / Completed

CompletedNCT03677323

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
60 (actual)
Sponsor
Clinique Saint Jean, France · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEVirtual realityThe 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.
DRUGDroleptanVenous administration of 1.25 mg of Droleptan
DRUGPropofolVenous administration of 20 mg of Propofol
DRUGSufentanylVenous administration of 5 μg of Sufentanyl.

Timeline

Start date
2019-01-02
Primary completion
2019-02-21
Completion
2019-02-21
First posted
2018-09-19
Last updated
2019-03-26

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT03677323. Inclusion in this directory is not an endorsement.