Trials / Withdrawn
WithdrawnNCT04379882
Feasibility Study Evaluating the Silva Module During the Anaesthesiology Consultation Before an Elective Surgery
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Oncomfort · Industry
- Sex
- All
- Age
- 18 Years – 100 Years
- Healthy volunteers
- Accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Digital Sedation (Silva) | Use of Digital Sedation (virtual reality associated with psychological interventions) for preoperative anxiety management |
Timeline
- Start date
- 2020-11-10
- Primary completion
- 2020-12-10
- Completion
- 2020-12-20
- First posted
- 2020-05-08
- Last updated
- 2021-06-30
Source: ClinicalTrials.gov record NCT04379882. Inclusion in this directory is not an endorsement.