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

NCT05558449 | Completed Phase 4

• 1 other identifier: VRH.foot
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Foot Deformities; Regional Anesthesia Morbidity; Valgus; Hallux; Analgesia

Outcome Measures

Primary Outcomes (1)

• (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 Outcomes (8)

• Anxiety

  5 minutes after the end of the surgery

• Quality of Recovery- 15 items (QoR-15)

  1 day before, 1 and 3 day after surgery

• Length of surgery

  5 minutes after the end of the surgery

• Complications

  6 hours after surgery

• VRH complications

  6 hours after surgery

Study Arms (3)

VR

ACTIVE COMPARATOR

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

VRH

EXPERIMENTAL

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

C

ACTIVE COMPARATOR

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

Interventions

Hypnosedation DEVICE

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.

VRH

Midazolam injection DRUG

Midazolam intravenous injection 1 mg until RASS -3

C

Virtual reality DEVICE

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.

VR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Liege: lead

Study Sites (1)

CHU de Liège

Liège, 4000, Belgium

Location

Related Publications (1)

• Carella M, Bicego A, Beck F, Malta C, Ardizzone L, Bonhomme VL, Vanhaudenhuyse A. Influence of virtual reality with or without hypnosis on patient-related experience and functional recovery in outpatient foot surgery with regional anesthesia: a randomized controlled trial. Reg Anesth Pain Med. 2025 Jun 22:rapm-2025-106678. doi: 10.1136/rapm-2025-106678. Online ahead of print.

  PMID: 40545295 DERIVED

MeSH Terms

Conditions

Foot Deformities; Hallux Valgus; Agnosia

Interventions

Hypnosis, Anesthetic; Midazolam

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Clinic, Anesthesiology and Intensive Care Department

Model Details: Prospective Randomized Clinical Trial

Study Record Dates

• First Submitted: September 22, 2022
• First Posted: September 28, 2022
• Study Start: November 28, 2022
• Primary Completion: October 16, 2023
• Study Completion: October 16, 2023
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)