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

NCT04379882 | Withdrawn

• 1 other identifier: OC32 Silva
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Preoperative Anxiety

Outcome Measures

Primary Outcomes (1)

• Evaluate the acceptability and the patient's qualitative reported experience of Silva

  questionnaire

  Day 1 of the intervention

Secondary Outcomes (3)

• Evaluate Anxiety

  Day 1 of the intervention

• Evaluate Comfort

  Day 1 of the intervention

• Evaluation of agreeability of the Digital Sedation session

  Day 1 of the intervention

Study Arms (1)

Digital sedation

EXPERIMENTAL

30 minutes Silva module

Device: Digital Sedation (Silva)

Interventions

Digital Sedation (Silva) DEVICE

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

Digital sedation

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject more than 18 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• Oncomfort: lead
• Erasme University Hospital: collaborator

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2020
• First Posted: May 8, 2020
• Study Start: November 10, 2020
• Primary Completion: December 10, 2020
• Study Completion: December 20, 2020
• Last Updated: June 30, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share