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

Impact of Virtual Reality Hypno-sedation on Functional Recovery and Anxiety in Foot Surgery With Regional Anesthesia: a Randomized Clinical Trial.

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.

Study Overview

• Status: Completed
• Conditions: Analgesia; Foot Deformities; Regional Anesthesia Morbidity; Valgus; Hallux
• Intervention / Treatment: Device: Virtual reality; Device: Hypnosedation; Drug: Midazolam injection

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 Type: Interventional
• Enrollment (Actual): 57
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Liège, Belgium, 4000
    • CHU de Liège

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: VR; 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.	Device: Virtual reality; Only virtual reality without a hypnosedation session. The virtual reality headset will be used on these patients without external voice or hypnosis device. The virtual reality module used will be "Silva", i.e. a scenario of a walk in the forest through the 4 seasons.
Experimental: VRH; 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.	Device: Hypnosedation; Hypnosedation session with a virtual reality headset during the regional 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.
Active Comparator: C; 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.	Drug: Midazolam injection; Midazolam intravenous injection 1 mg until RASS -3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
(Evaluation du Vecu de l'Anesthesie LocoRegionale) EVAN-LR	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.	4 hours after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Liege

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2022
• Primary Completion (Actual): October 16, 2023
• Study Completion (Actual): October 16, 2023

Study Registration Dates

• First Submitted: September 22, 2022
• First Submitted That Met QC Criteria: September 27, 2022
• First Posted (Actual): September 28, 2022

Study Record Updates

• Last Update Posted (Actual): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Limb Deformities, Congenital; Lower Extremity Deformities, Congenital; Foot Deformities; Foot Deformities, Congenital; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam
• Other Study ID Numbers: VRH.foot

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No