Clinical trial NCT03677323: Evaluation of the Efficacy of VR on Pain and Anxiety When Performing an Ultrasound-controlled Ankle Block.
Official title: Evaluation of the Efficacy of VR on Pain and Anxiety When Performing an Ultrasound-controlled Ankle Block.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hallux Valgus
Surgery
Keywords: virtual reality
pain
anxiety
Lead sponsor: Clinique Saint Jean, France
Sponsor class: OTHER
First posted: 2018-09-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Digital visual scale to assess pain of patients during the treatment
timeFrame: 5 min after the first nerve punction
measure: Digital visual scale to assess anxiety of patients during the treatment
timeFrame: 5 min after the first nerve punction
Secondary outcomes:
measure: Patient satisfaction questionnaire
timeFrame: 5 min after the last nerve punction
measure: Patient comfort assessment questionnaire
timeFrame: 5 min after the last nerve punction
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Clinique Saint Jean
Study officials:
affiliation: Clinique Saint Jean, Montpellier
name: Thomas PILLANT, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mosso JL, Gorini A, De La Cerda G, Obrador T, Almazan A, Mosso D, Nieto JJ, Riva G. Virtual reality on mobile phones to reduce anxiety in outpatient surgery. Stud Health Technol Inform. 2009;142:195-200.
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citation: Burt DE. Virtual reality in anaesthesia. Br J Anaesth. 1995 Oct;75(4):472-80. doi: 10.1093/bja/75.4.472. No abstract available.