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

NCT ID: NCT05558449

Last Updated: 2024-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-28
• Study Completion Date: 2023-10-16

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Virtual reality

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Hypnosedation

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Midazolam injection

Intervention Type: DRUG

Midazolam intravenous injection 1 mg until RASS -3

Interventions

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.

Intervention Type: DEVICE

Midazolam injection

Midazolam intravenous injection 1 mg until RASS -3

Intervention Type: DRUG

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Liege

OTHER

Sponsor Role: lead

Responsible Party

Michele Carella

Head of Clinic, Anesthesiology and Intensive Care Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

CHU de Liège

Liège, , Belgium

Countries

Belgium

References

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.

Reference Type: DERIVED

PMID: 40545295 (View on PubMed)

Other Identifiers

VRH.foot

Identifier Type: -

Identifier Source: org_study_id