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

Sponsor

Clinique Saint Jean, France (Other)

Overall Status

Completed

CT.gov ID

NCT03677323

Collaborator

(none)

Enrollment

Location

Arms

1.6

Actual Duration (Months)

36.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hallux Valgus Surgery	Device: Virtual reality Drug: Droleptan Drug: Propofol Drug: Sufentanyl	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 2, 2019

Actual Primary Completion Date :

Feb 21, 2019

Actual Study Completion Date :

Feb 21, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Virtual reality The virtual reality device will consist of the virtual reality headset and headphones for full immersion.	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
Active Comparator: Drug sedation The sedation group will benefit from drug sedation used in current practice, that is to say an association of Sufentanil, Droleptan and Propofol.	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

Arm

Intervention/Treatment

Experimental: Virtual reality

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

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:

Active Comparator: Drug sedation

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

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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. : very comfortable : comfortable : less comfortable : uncomfortable : very uncomfortable

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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