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

NCT05558449 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2024-03-06

No results posted yet for this study

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

Interventions

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.

DRUG

Midazolam injection

Midazolam intravenous injection 1 mg until RASS -3

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.

Sponsors & Collaborators

  • University of Liege

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-28
Primary Completion
2023-10-16
Completion
2023-10-16

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05558449 on ClinicalTrials.gov