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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Preoperative Anxiety

Intervention / Treatment
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* Device: Digital Sedation (Silva)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 |