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

Sponsor
Oncomfort (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT04379882
Collaborator
Erasme University Hospital (Other)
0
Enrollment
1
Arm
1.3
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Digital Sedation (Silva)
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Feasibility Study Evaluating the Silva Module During the Anaesthesiology Consultation Before an Elective Surgery
Anticipated Study Start Date :
Nov 10, 2020
Anticipated Primary Completion Date :
Dec 10, 2020
Anticipated Study Completion Date :
Dec 20, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Evaluate the acceptability and the patient's qualitative reported experience of Silva [Day 1 of the intervention]

    questionnaire

Secondary Outcome Measures

  1. Evaluate Anxiety [Day 1 of the intervention]

    questionnaire VAS 0 (no anxiety)- 10 (max anxiety)

  2. Evaluate Comfort [Day 1 of the intervention]

    questionnaire VAS 0 (extreme discomfort)- 10 (extreme comfort)

  3. Evaluation of agreeability of the Digital Sedation session [Day 1 of the intervention]

    questionnaire VAS (0-10) 0: not agreeable, 10: extremely agreeable

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Oncomfort
  • Erasme University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Oncomfort
ClinicalTrials.gov Identifier:
NCT04379882
Other Study ID Numbers:
  • OC32 Silva
First Posted:
May 8, 2020
Last Update Posted:
Jun 30, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jun 30, 2021