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Feasibility Study Evaluating the Silva Module During the Anaesthesiology Consultation Before an Elective Surgery

NCT04379882 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-06-30

No results posted yet for this study

Summary

In this feasibility study, feasibility, acceptability and an initial clinical efficacy of the new module of Hypnosis and Virtual Reality (or Digital Sedation), Silva, will be evaluated. This feasibility study meets objectives of Oncomfort's design validation and design verification steps. Silva will be tested on a sample of 10 patients in the environment where the product is intended to be used, a hospital environment. If results do not fit with user needs, design will be adapted according to results and a new phase of design validation will be implemented. The Silva module is a Digital Sedation module designed for management of pain and anxiety in perioperative patients.

Conditions

  • Preoperative Anxiety

Interventions

DEVICE

Digital Sedation (Silva)

Use of Digital Sedation (virtual reality associated with psychological interventions) for preoperative anxiety management

Sponsors & Collaborators

  • Erasme University Hospital

    collaborator OTHER

  • Oncomfort

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-10
Primary Completion
2020-12-10
Completion
2020-12-20

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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 NCT04379882 on ClinicalTrials.gov