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

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.

Study Overview

• Status: Withdrawn
• Conditions: Preoperative Anxiety
• Intervention / Treatment: Device: Digital Sedation (Silva)

Detailed Description

Subjects will be recruited during the anaesthesiology consultation preparing to an elective surgery.

First, subject will be asked to self-assess anxiety and comfort. In order to evaluate anxiety, subject will use a 0-10 rating Visual Analogue Scale (VAS) where 0 = no anxiety at all, and 10= the worst imaginable anxiety. The same scale will be used to measure the level of comfort where 0 means no comfort at all and 10 very comfortable.

Subject should be positioned laying on a reclining chair during the session. This session will last for 30 minutes. After the experiment, participants will be asked to rate anxiety, level of comfort, level of immersion and dissociation.

Several questions will be asked to the patient to evaluate his/ her experience, the Silva module, and the sensations experienced.

The study will be ended by an evaluation of adverse event (AE) and the evaluation of the caregivers.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subject more than 18 years old

Exclusion Criteria:

• Deaf subject
• Blind
• Non-proficiency in French (Module language)
• Psychiatric disorder
• Head or face wounds
• Neurological disease
• Chronic pain and/or chronic analgesics consumption
• Medication affecting the autonomic nervous system
• Dizziness

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Digital sedation; 30 minutes Silva module	Device: Digital Sedation (Silva); Use of Digital Sedation (virtual reality associated with psychological interventions) for preoperative anxiety management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the acceptability and the patient's qualitative reported experience of Silva	questionnaire	Day 1 of the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate Anxiety	questionnaire VAS 0 (no anxiety)- 10 (max anxiety)	Day 1 of the intervention
Evaluate Comfort	questionnaire VAS 0 (extreme discomfort)- 10 (extreme comfort)	Day 1 of the intervention
Evaluation of agreeability of the Digital Sedation session	questionnaire VAS (0-10) 0: not agreeable, 10: extremely agreeable	Day 1 of the intervention

Collaborators and Investigators

• Sponsor: Oncomfort
• Collaborators: Erasme University Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): November 10, 2020
• Primary Completion (Anticipated): December 10, 2020
• Study Completion (Anticipated): December 20, 2020

Study Registration Dates

• First Submitted: April 17, 2020
• First Submitted That Met QC Criteria: May 7, 2020
• First Posted (Actual): May 8, 2020

Study Record Updates

• Last Update Posted (Actual): June 30, 2021
• Last Update Submitted That Met QC Criteria: June 25, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: OC32 Silva

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No