Clinical trial

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

Name

VRH.foot

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.

Trial arms

Trial start

2022-11-28

Estimated PCD

2023-10-16

Trial end

2023-10-16

Status

Completed

Phase

Early phase I

Treatment

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.

Arms:

VRH

Midazolam injection

Midazolam intravenous injection 1 mg until RASS -3

Arms:

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.

Arms:

Size

Primary endpoint

(Evaluation du Vecu de l'Anesthesie LocoRegionale) EVAN-LR

4 hours after 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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective Randomized Clinical Trial', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Open'}}, 'enrollmentInfo': {'count': 57, 'type': 'ACTUAL'}}

Updated at

2024-03-06

1 organization

Organization

University of Liege