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

Not Applicable

Withdrawn

• Conditions: Preoperative Anxiety
• Interventions: Device: Digital Sedation (Silva)

• Registration Number: NCT04379882
• Lead Sponsor: Oncomfort

Brief 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.

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 Timeline

• Study First Submitted: 2020-04-17
• Study First Submitted QC: 2020-05-07
• Study First Posted: 2020-05-08
• Study Start: 2020-11-10
• Primary Completion: 2020-12-10
• Study Completion: 2020-12-20
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-25
• Last Update Posted: 2021-06-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Digital sedation	Digital Sedation (Silva)	30 minutes Silva module

Primary Outcome Measures

Name	Time	Method
Evaluate the acceptability and the patient's qualitative reported experience of Silva	Day 1 of the intervention	questionnaire

Secondary Outcome Measures

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