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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04379882
Other study ID # OC32 Silva
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
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
Health authority
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Status Withdrawn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

Study Design


Related Conditions & MeSH terms


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
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