Clinical trial NCT05558449: Impact of Virtual Reality Hypno-sedation on Functional Recovery and Anxiety in Foot Surgery With Regional Anesthesia
Official title: Impact of Virtual Reality Hypno-sedation on Functional Recovery and Anxiety in Foot Surgery With Regional Anesthesia: a Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Foot Deformities
Regional Anesthesia Morbidity
Valgus; Hallux
Analgesia
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2022-09-28
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective Randomized Clinical Trial
Primary purpose: TREATMENT

Brief summary: This prospective study aims to evaluate whether the implementation of a virtual reality hypnosedation (VRH)protocol reduces preoperative anxiety and increases patient comfort before, during, and after outpatient foot surgery.

Detailed description: This prospective study aims to evaluate whether the implementation of a virtual reality hypnosedation (VRH) protocol reduces preoperative anxiety and increases patient comfort before, during, and after outpatient foot surgery. The investigators hope to demonstrate a reduction in anxiety, improved postoperative experience and functional recovery according to currently validated scores measuring preoperative and postoperative recovery, anxiety and stress, and experience during a regional anesthesia technique.

The investigators expect that VRH will be more effective than VR alone and conventional pharmacological sedation in reducing preoperative anxiety and in improving experience and functional recovery. If the hypothesis is correct, the investigators could propose to integrate this protocol as a first line in the ambulatory management of elective foot surgery.

Eligibility criteria: Inclusion Criteria:

* Major patients, classified as ASA 1-2-3, admitted for foot surgery (metatarsophalangeal arthrodesis or hallux valgus cure), under peripheral locoregional anesthesia (sciatic nerve block at popliteal level).

Exclusion Criteria:

* pregnant women
* patients with peripheral neuropathy or other severe neurological pathology
* allergy or contraindication to local anesthetics or benzodiazepines
* chronic renal failure or severe hepatic failure
* major hemostasis disorders
* severe vision or hearing problems that would render the VR and VRH device useless or unusable, and patient contraindication or refusal to use the VRH headset, such as claustrophobia or kinesiophobia.

Primary outcomes:
measure: (Evaluation du Vecu de l'Anesthesie LocoRegionale) EVAN-LR
timeFrame: 4 hours after surgery
Secondary outcomes:
measure: Anxiety
timeFrame: 5 minutes after the end of the surgery
measure: Quality of Recovery- 15 items (QoR-15)
timeFrame: 1 day before, 1 and 3 day after surgery
measure: Length of surgery
timeFrame: 5 minutes after the end of the surgery
measure: Complications
timeFrame: 6 hours after surgery
measure: VRH complications
timeFrame: 6 hours after surgery
measure: Time perception
timeFrame: 5 minutes after the end of the surgery
measure: Surgeon satisfaction
timeFrame: 5 minutes after the end of the surgery
measure: Dissociation
timeFrame: 5 minutes after the end of the surgery
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: CHU de Liège
Study officials:
References: