Pacemaker DDDNCT05695534
Use of VR in Patients' Education Prior to Implantation of PPM
A study testing VR educational video in people with Pacemaker DDD, run by Adela Drozdova.
Trial summary
The aim of this study is to compare standard education with VR augmented education in patients prior to implantation of a permanent pacemaker. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Pacemaker DDD
- What is being tested?
- VR educational video
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 25 Jan 2023to 30 Jun 2024
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Use of Virtual Reality in Patients' Education Prior to Implantation of Permanent Pacemaker
The aim of this study is to compare standard education with VR augmented education in patients prior to implantation of a permanent pacemaker.
Read the detailed description
The aim of this study is to compare standard education (doctor and nurse led) with Virtual Reality (VR) augmented education in patients prior to implantation of a permanent pacemaker. A 360° education video was prepared in the operating theatre and other areas of the hospital to make patients more comfortable with these unfamilliar places. The procedure was explained in details by a doctor and animations were used to help patients to visualise the procedure. Risks and complications of the procedure were highlited along with the precautionary measures patients need to take after the procedure.
Patients coming into the One-Day Cardilogy Unit of Podlesi Hospital will be randomised into 2 groups: Standard education and VR augmented education. The VR group will be then educated using VR and will be given an opportunity to ask a physician more questions if needed. Patients will then fill in forms to assess their experience, feelings and knowledge about the procedure. Data will be then collected to assess if VR could facilitate patients' education. The investigators believe it could be a useful tool to save time of doctors and nurses which is becoming more and more precious and expensive.
- Conditions
- Pacemaker DDD
- Being tested
- VR educational video
- Keywords
- Virtual Reality, Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR educational videoOther
Patients will be educated with our specifically made VR video in the settings of our hospital to make patients more familliar with the spaces and to explain them the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Standard education | No intervention | Patients will be educated about the procedure in a standard way by a docture and a nurse |
| VR Education | Experimental | Patients will be educated with the use of virtual reality Receives: Other: VR educational video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of VR augmented eduacation assessed by a questionaire
A questionaire with questions assessing patients' personal experience and knowledge of the procedure was prepared. This will be collected and compared to patients with a standard education.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start25 Jan 2023 (estimated)
- Primary completion5 Jan 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pacemaker DDDStudies 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
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adela Drozdova
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Adela Drozdova, Nemocnice AGEL Trinec-Podlesi a.s.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05695534
- Sponsor's protocol ID
- AGELTrinecPodlesi
- Status last verified
- Jan 2023
- First submitted
- 5 Jan 2023
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Only basic demographic data will be shared
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Virtual Reality in Patients' Education Prior to Implantation of Permanent Pacemaker
- ClinicalTrials.gov ID
- NCT05695534
- Acronym / sponsor ID
- AGELTrinecPodlesi
- Conditions
- Pacemaker DDD
- Keywords
- Virtual Reality, Education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Adela DrozdovaUniversity, hospital or other
- Study start
- 25 Jan 2023 (estimated)
- Primary completion
- 5 Jan 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 25 Jan 2023 (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.
The aim of this study is to compare standard education with VR augmented education in patients prior to implantation of a permanent pacemaker.
Detailed description
The aim of this study is to compare standard education (doctor and nurse led) with Virtual Reality (VR) augmented education in patients prior to implantation of a permanent pacemaker. A 360° education video was prepared in the operating theatre and other areas of the hospital to make patients more comfortable with these unfamilliar places. The procedure was explained in details by a doctor and animations were used to help patients to visualise the procedure. Risks and complications of the procedure were highlited along with the precautionary measures patients need to take after the procedure.
Patients coming into the One-Day Cardilogy Unit of Podlesi Hospital will be randomised into 2 groups: Standard education and VR augmented education. The VR group will be then educated using VR and will be given an opportunity to ask a physician more questions if needed. Patients will then fill in forms to assess their experience, feelings and knowledge about the procedure. Data will be then collected to assess if VR could facilitate patients' education. The investigators believe it could be a useful tool to save time of doctors and nurses which is becoming more and more precious and expensive.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard education | No intervention | –Patients will be educated about the procedure in a standard way by a docture and a nurse |
| VR Education | Experimental | Other: VR educational videoPatients will be educated with the use of virtual reality |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| VR educational videoPatients will be educated with our specifically made VR video in the settings of our hospital to make patients more familliar with the spaces and to explain them the procedure. | Other | VR Education |
Primary outcome
Quality of VR augmented eduacation assessed by a questionaire
Time frame: 18 months
A questionaire with questions assessing patients' personal experience and knowledge of the procedure was prepared. This will be collected and compared to patients with a standard education.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
- Individual participant dataSharing planned: Undecided. Only basic demographic data will be shared
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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.
Questions about this trial
What is this clinical trial studying?
A study testing VR educational video in people with Pacemaker DDD, run by Adela Drozdova.
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 0 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 25 Jan 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adéla Drozdová, MUDr. (+420607147489, drozdova.adela@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of VR augmented eduacation assessed by a questionaire (time frame: 18 months). 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 25 Jan 2023.