Evaluation of the Efficacy of VR on Pain and Anxiety When Performing an Ultrasound-controlled Ankle Block.
Overview
- Phase
- Not Applicable
- Intervention
- Virtual reality
- Conditions
- Hallux Valgus
- Sponsor
- Clinique Saint Jean, France
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Digital visual scale to assess anxiety of patients during the treatment
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility 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
Arms & Interventions
Virtual reality
The virtual reality device will consist of the virtual reality headset and headphones for full immersion.
Intervention: Virtual reality
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.
Intervention: Droleptan
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.
Intervention: Propofol
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.
Intervention: Sufentanyl
Outcomes
Primary Outcomes
Digital visual scale to assess anxiety of patients during the treatment
Time Frame: 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
Time Frame: 5 min after the first nerve punction
Numeric scale numbered from 0 to 10. 0: no pain 10 : worst possible pain
Secondary Outcomes
- Patient comfort assessment questionnaire(5 min after the last nerve punction)
- Patient satisfaction questionnaire(5 min after the last nerve punction)