Virtual RealityVirtuCardioNCT05588232
the Effectiveness of Therapeutic Virtual Reality Versus Pharmacological Sedation on Pain and Anxiety During Interventional Cardiology Procedures
A study testing scheduled outpatient interventions in interventional cardiology in people with Virtual Reality and Drug Sedation, run by Elsan at 1 site in France.
Trial summary
Immersion sedation in virtual reality could be an alternative to conventional pharmacological sedation, during interventional cardiology acts on pain and anxiety control. The objective of this study is to determine whether virtual reality immersion is non-inferior to drug sedation on pain and anxiety, during coronary… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Virtual Reality, Drug Sedation, Coronarography
- What is being tested?
- scheduled outpatient interventions in interventional cardiology
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteFrance
- Study dates
- 18 Oct 2021to 24 Feb 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient
- who must benefit from one of the following scheduled interventional cardiology outpatient procedures: coronary angiography, coronary angioplasty, peripheral angioplasty (lower limbs)
- Affiliation to a social security scheme or beneficiary of such a scheme.
- Patient having signed the free and informed consent
Who cannot join
- Dementia
- Language barrier
- Claustrophobia
- Nausea
- History of intolerance to Virtual Reality
- Patient with epilepsy
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- Refusal to participate in the study
- Protected patient: minor, adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
- Pregnant, breastfeeding or parturient woman
- Unstable patient (state of shock, respiratory or neurological distress)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Comparative Study Evaluating the Efficacy of Therapeutic Virtual Reality Versus Pharmacological Sedation on Pain and Anxiety During Interventional Cardiology Procedures
Immersion sedation in virtual reality could be an alternative to conventional pharmacological sedation, during interventional cardiology acts on pain and anxiety control.
The objective of this study is to determine whether virtual reality immersion is non-inferior to drug sedation on pain and anxiety, during coronary angiography or angioplasty.
- Conditions
- Virtual Reality, Drug Sedation, Coronarography, Angiography
- Being tested
- scheduled outpatient interventions in interventional cardiology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
scheduled outpatient interventions in interventional cardiologyProcedure or surgery
coronary angiography, coronary angioplasty, peripheral angioplasty (carotid arteries or lower limbs)
| Study group | Role | What they receive |
|---|---|---|
| Patient with virtual reality | Experimental | The virtual reality sedation-analgesia solution developed by Deepsen combines 3D environment content with medical hypnosis techniques. The technology includes a wearable visual headset that contains head movement sensors, enabling patient interaction in the virtual environment, as well as isolating headphones. Receives: Procedure: scheduled outpatient interventions in interventional cardiology |
| Patient with pharmacological sedation | Active comparator | Not described Receives: Procedure: scheduled outpatient interventions in interventional cardiology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum pain during the interventional cardiology procedures
measured on a scale of 0 to 10.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start18 Oct 2021
- Primary completion11 Dec 2021
- Study completion24 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Virtual RealityStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Monocentric, prospective, comparative, randomized, open-label study.
- Masking
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elsan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05588232
- Sponsor's protocol ID
- 2021-A01130-41
- Acronym
- VirtuCardio
- Status last verified
- Oct 2022
- First submitted
- 18 Oct 2022
- Last updated
- 21 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Comparative Study Evaluating the Efficacy of Therapeutic Virtual Reality Versus Pharmacological Sedation on Pain and Anxiety During Interventional Cardiology Procedures
- ClinicalTrials.gov ID
- NCT05588232
- Acronym / sponsor ID
- VirtuCardio / 2021-A01130-41
- Conditions
- Virtual Reality, Drug Sedation, Coronarography, Angiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- ElsanUniversity, hospital or other
- Study start
- 18 Oct 2021 (actual)
- Primary completion
- 11 Dec 2021 (actual)
- Study completion
- 24 Feb 2022 (actual)
- First posted
- 20 Oct 2022 (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.
Immersion sedation in virtual reality could be an alternative to conventional pharmacological sedation, during interventional cardiology acts on pain and anxiety control.
The objective of this study is to determine whether virtual reality immersion is non-inferior to drug sedation on pain and anxiety, during coronary angiography or angioplasty.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Monocentric, prospective, comparative, randomized, open-label study.
| Arm | Type | Receives |
|---|---|---|
| Patient with virtual reality | Experimental | Procedure: scheduled outpatient interventions in interventional cardiologyThe virtual reality sedation-analgesia solution developed by Deepsen combines 3D environment content with medical hypnosis techniques. The technology includes a wearable visual headset that contains head movement sensors, enabling patient interaction in the virtual environment, as well as isolating headphones. |
| Patient with pharmacological sedation | Active comparator | Procedure: scheduled outpatient interventions in interventional cardiology |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patient
- who must benefit from one of the following scheduled interventional cardiology outpatient procedures: coronary angiography, coronary angioplasty, peripheral angioplasty (lower limbs)
- Affiliation to a social security scheme or beneficiary of such a scheme.
- Patient having signed the free and informed consent
Key exclusion criteria (10 listed)
- Dementia
- Language barrier
- Claustrophobia
- Nausea
- History of intolerance to Virtual Reality
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 |
|---|---|---|
| scheduled outpatient interventions in interventional cardiologycoronary angiography, coronary angioplasty, peripheral angioplasty (carotid arteries or lower limbs) | Procedure or surgery | Patient with pharmacological sedation, Patient with virtual reality |
Primary outcome
Maximum pain during the interventional cardiology procedures
Time frame: 1 day
measured on a scale of 0 to 10.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing scheduled outpatient interventions in interventional cardiology in people with Virtual Reality and Drug Sedation, run by Elsan at 1 site in France.
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 4 inclusion and 10 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: finished, as of the sponsor's last update on 21 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximum pain during the interventional cardiology procedures (time frame: 1 day). 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 21 Oct 2022.