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
| Type | Name | Description |
|---|---|---|
| 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. |
| DRUG | Droleptan | Venous administration of 1.25 mg of Droleptan |
| DRUG | Propofol | Venous administration of 20 mg of Propofol |
| DRUG | Sufentanyl | Venous 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.