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

Not Applicable

Completed

• Conditions: Hallux Valgus; Surgery
• Interventions: Device: Virtual reality; Drug: Droleptan; Drug: Propofol; Drug: Sufentanyl

• Registration Number: NCT03677323
• Lead Sponsor: Clinique Saint Jean, France

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.

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 Timeline

• Study First Submitted: 2018-09-13
• Study First Submitted QC: 2018-09-18
• Study First Posted: 2018-09-19
• Study Start: 2019-01-02
• Primary Completion: 2019-02-21
• Study Completion: 2019-02-21
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-25
• Last Update Posted: 2019-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual reality	Virtual reality	The virtual reality device will consist of the virtual reality headset and headphones for full immersion.
Drug sedation	Droleptan	The sedation group will benefit from drug sedation used in current practice, that is to say an association of Sufentanil, Droleptan and Propofol.
Drug sedation	Propofol	The sedation group will benefit from drug sedation used in current practice, that is to say an association of Sufentanil, Droleptan and Propofol.
Drug sedation	Sufentanyl	The sedation group will benefit from drug sedation used in current practice, that is to say an association of Sufentanil, Droleptan and Propofol.

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
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.; 1. : very comfortable; 2. : comfortable; 3. : less comfortable; 4. : uncomfortable; 5. : very uncomfortable
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

Trial Locations

Locations (1)

Clinique Saint Jean; 🇫🇷 Montpellier, France