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

Preoperative Anxiety Clinical Trial

— Silva  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04379882
• Other study ID #: OC32 Silva
• Status: Withdrawn
• Phase: N/A
• Start date: November 10, 2020
• Est. completion date: December 20, 2020

Study information

• Verified date: June 2021
• Source: Oncomfort
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 20, 2020
• Est. primary completion date: December 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Preoperative Anxiety

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Oncomfort	Erasme University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the acceptability and the patient's qualitative reported experience of Silva	questionnaire	Day 1 of the intervention
Secondary	Evaluate Anxiety	questionnaire VAS 0 (no anxiety)- 10 (max anxiety)	Day 1 of the intervention
Secondary	Evaluate Comfort	questionnaire VAS 0 (extreme discomfort)- 10 (extreme comfort)	Day 1 of the intervention
Secondary	Evaluation of agreeability of the Digital Sedation session	questionnaire VAS (0-10) 0: not agreeable, 10: extremely agreeable	Day 1 of the intervention