Trial | NCT03677323  Report issue

Official Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    60
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.
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.
Study Started
Jan 02
2019
Primary Completion
Feb 21
2019
Study Completion
Feb 21
2019
Last Update
Mar 26
2019

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.

  • Other names: VR

Drug Droleptan

Venous administration of 1.25 mg of Droleptan

  • Other names: Sedation

Drug Propofol

Venous administration of 20 mg of Propofol

  • Other names: Sedation

Drug Sufentanyl

Venous administration of 5 μg of Sufentanyl.

  • Other names: Sedation

Virtual reality Experimental

The virtual reality device will consist of the virtual reality headset and headphones for full immersion.

Drug sedation Active Comparator

The sedation group will benefit from drug sedation used in current practice, that is to say an association of Sufentanil, Droleptan and Propofol.

Criteria 

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
No Results Posted