Impact of Virtual Reality Hypno-sedation on Functional Recovery and Anxiety in Foot Surgery With Regional Anesthesia

Phase 4

Completed

• Conditions: Foot Deformities; Analgesia; Regional Anesthesia Morbidity; Valgus; Hallux
• Interventions: Drug: Midazolam injection; Device: Virtual reality; Device: Hypnosedation

• Registration Number: NCT05558449
• Lead Sponsor: University of Liege

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.

Study Timeline

• Study First Submitted: 2022-09-22
• Study First Submitted QC: 2022-09-27
• Study First Posted: 2022-09-28
• Study Start: 2022-11-28
• Primary Completion: 2023-10-16
• Study Completion: 2023-10-16
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
C	Midazolam injection	Patients in group C (control group, 19 patients) will receive only midazolam-based pharmacological sedation. This will be administered with intermittent boluses of 1 mg until patient comfort and sedation on the Richmond analgo-sedation scale (RASS) of -3 (response to verbal stimulus) is achieved.
VR	Virtual reality	Patients in the VR group (19 patients) will receive VR alone without hypnosedation. The VR headset will be used on these patients without an external voice or device allowing hypnosis. The VR module used will be "Silva", i.e. a scenario of a walk in the forest through the 4 seasons.
VRH	Hypnosedation	The patients in the VRH group (19 patients) will benefit from a hypnosedation session with a VRH headset during the local anesthesia technique and during the surgery (approximately 60 minutes). The VRH module used will be "Silva", i.e. the same scenario of a walk in the forest through the 4 seasons with a voice accompanying the hypnosis session.

Primary Outcome Measures

Name	Time	Method
(Evaluation du Vecu de l'Anesthesie LocoRegionale) EVAN-LR	4 hours after surgery	The primary endpoint will be the EVAN-LR score as a measure of intraoperative experience. EVAN-LR: a 0-100 scale, with 100 indicating the best possible level of satisfaction and 0 the worst.

Secondary Outcome Measures

Name	Time	Method
Time perception	5 minutes after the end of the surgery	Perception of the duration of the surgery during the VRH.
Dissociation	5 minutes after the end of the surgery	The Numeric rating scale (NRS) (0-10) dissociation for the assessment of dissociation during the surgery
Quality of Recovery- 15 items (QoR-15)	1 day before, 1 and 3 day after surgery	Assessment of the QoR-15 score on postoperative functional recovery and the variation in time between the day before surgery, the day after and 3 days after surgery
Complications	6 hours after surgery	The occurrence of complications related to the techniques used
VRH complications	6 hours after surgery	The occurrence of side effects related to virtual reality (nausea, paradoxical anxiety, dizziness, etc.)
Anxiety	5 minutes after the end of the surgery	Numeric rating scale (NRS) (0 to 10) for pre- and postoperative anxiety
Length of surgery	5 minutes after the end of the surgery	Length of surgery procedure in minutes
Surgeon satisfaction	5 minutes after the end of the surgery	Surgeon satisfaction on a numeric rating scale from 0 to 10

Trial Locations

Locations (1)

CHU de Liège; 🇧🇪 Liège, Belgium