Preoperative AnxietySilvaNCT04379882
Feasibility Study Evaluating the Silva Module During the Anaesthesiology Consultation Before an Elective Surgery
A study testing Digital Sedation (Silva) in people with Preoperative Anxiety, run by Oncomfort.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Preoperative Anxiety
- What is being tested?
- Digital Sedation (Silva)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 10 Nov 2020to 20 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject more than 18 years old
Who cannot join
- Deaf subject
- Blind
- Non-proficiency in French (Module language)
- Psychiatric disorder
- Head or face wounds
- Neurological disease
Show all 9Show fewer
- Chronic pain and/or chronic analgesics consumption
- Medication affecting the autonomic nervous system
- Dizziness
About this study
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.
Read the 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
- Preoperative Anxiety
- Being tested
- Digital Sedation (Silva)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Sedation (Silva)Device
Use of Digital Sedation (virtual reality associated with psychological interventions) for preoperative anxiety management
| Study group | Role | What they receive |
|---|---|---|
| Digital sedation | Experimental | 30 minutes Silva module Receives: Device: Digital Sedation (Silva) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the acceptability and the patient's qualitative reported experience of Silva
questionnaire
Measured: Day 1 of the intervention
Secondary outcomes (3)
Evaluate Anxiety
questionnaire VAS 0 (no anxiety)- 10 (max anxiety)
Measured: Day 1 of the intervention
Evaluate Comfort
questionnaire VAS 0 (extreme discomfort)- 10 (extreme comfort)
Measured: Day 1 of the intervention
Evaluation of agreeability of the Digital Sedation session
questionnaire VAS (0-10) 0: not agreeable, 10: extremely agreeable
Measured: Day 1 of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2020
- Study start10 Nov 2020 (estimated)
- Primary completion10 Dec 2020 (estimated)
- Study completion20 Dec 2020 (estimated)
Why it stopped: Decision of alternative research to be performed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oncomfort
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Erasme University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04379882
- Sponsor's protocol ID
- OC32 Silva
- Acronym
- Silva
- Status last verified
- Jun 2021
- First submitted
- 17 Apr 2020
- Last updated
- 30 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study Evaluating the Silva Module During the Anaesthesiology Consultation Before an Elective Surgery
- ClinicalTrials.gov ID
- NCT04379882
- Acronym / sponsor ID
- Silva / OC32 Silva
- Conditions
- Preoperative Anxiety
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Decision of alternative research to be performed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- OncomfortIndustry (pharma, biotech, devices)
- Collaborators
- Erasme University Hospital
- Study start
- 10 Nov 2020 (estimated)
- Primary completion
- 10 Dec 2020 (estimated)
- Study completion
- 20 Dec 2020 (estimated)
- First posted
- 8 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Digital sedation | Experimental | Device: Digital Sedation (Silva)30 minutes Silva module |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subject more than 18 years old
Key exclusion criteria (9 listed)
- Deaf subject
- Blind
- Non-proficiency in French (Module language)
- Psychiatric disorder
- Head or face wounds
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Sedation (Silva)Use of Digital Sedation (virtual reality associated with psychological interventions) for preoperative anxiety management | Device | Digital sedation |
Primary outcome
Evaluate the acceptability and the patient's qualitative reported experience of Silva
Time frame: Day 1 of the intervention
questionnaire
3 secondary outcomes
Evaluate Anxiety
Time frame: Day 1 of the intervention
Evaluate Comfort
Time frame: Day 1 of the intervention
Evaluation of agreeability of the Digital Sedation session
Time frame: Day 1 of the intervention
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Sedation (Silva) in people with Preoperative Anxiety, run by Oncomfort.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the acceptability and the patient's qualitative reported experience of Silva (time frame: Day 1 of the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2021.