ArrhythmiaVR inEPNCT07105241
Virtual Reality in Electrophysiological Procedures and Device Implantation: the VR inEP Trial
A study testing VR therapy and 360 degree education videos in people with Arrhythmia and Cardiac Implantable Electronic Device, run by Radboud University Medical Center.
Trial summary
Each year about 37,000 patients undergo a catheter ablation to treat cardiac arrhythmias or have a cardiac device such as a pacemaker or implantable cardioverter defibrillator implanted in the Netherlands. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Arrhythmia, Cardiac Implantable Electronic Device, Ablation of Arrhythmias
- What is being tested?
- VR therapy and 360 degree education videos
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2025to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ≥16 years of age
- Planned to undergo an invasive electrophysiological procedure (e.g., catheter ablation or electrophysiological study) or cardiac device implantation (e.g., pacemaker or implantable cardioverter defibrillator).
- The procedure must be performed under local anesthesia.
Who cannot join
- Patients undergoing procedures using (conscious) sedation
- Patients who do not speak or understand Dutch
- History of dementia
- Severe visual impairment.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Each year about 37,000 patients undergo a catheter ablation to treat cardiac arrhythmias or have a cardiac device such as a pacemaker or implantable cardioverter defibrillator implanted in the Netherlands. Although the procedures positively impact health related outcomes on the long term, they are often accompanied by periprocedural pain and anxiety on a shorter term. These negative effects can be prevented or treated by pharmacological interventions (e.g. analgesics or benzodiazepines), but side effects of these drugs may compromise patient safety and extend hospital admissions. Distraction using Virtual Reality (VR) may be an attractive non-pharmacological alternative.
It is the aim of the Virtual Reality in Electrophysiological Procedures and device implantation (VR inEP) trial to study the feasibility and efficacy of VR to decrease experienced pain and anxiety in patients undergoing invasive procedures for arrhythmias and conduction disorders. The study also serves as a stepping stone towards structural implementation of VR into clinical care, by familiarizing care personnel of the cardiac catheterization rooms with the use of VR, its indications and logistics, and identifying potential barriers for structural implementation of VR.
VR inEP is a single-center, open label, randomized controlled trial performed in the catheterization rooms in the Radboudumc. Adult patients undergoing an electrophysiological procedure (e.g., catheter ablation or electrophysiological study) or cardiac device implantation (e.g., pacemaker or implantable cardioverter defibrillator) performed under local anesthesia are eligible for inclusion. Patients consenting to participate are randomized in a 1:1 ratio to the VR intervention or control group, stratified for the indication for the procedure (50% electrophysiological procedures, 50% cardiac device implantations). Patients and their treatment teams are unblinded for the treatment allocation. The primary outcomes are pain perception and anxiety during the procedure as a whole, quantified using the visual analog scale (VAS) for pain and the numeric ranking scale (NRS) for anxiety, 30 minutes after the procedure ends.
Read the detailed description
Rationale: Each year approximately 37,000 patients undergo a catheter ablation or cardiac device implantation in The Netherlands. Although the procedures positively impact health related outcomes, they are often accompanied by periprocedural pain and anxiety. These negative effects can be prevented or treated by pharmacological interventions (e.g. analgesics or benzodiazepines), but side effects of these drugs may compromise patient safety and extend hospital admissions. Distraction using Virtual Reality (VR) may be an attractive non-pharmacological alternative.
Objective: it is the aim of the Virtual Reality in Electrophysiological Procedures and device implantation (VR inEP) trial to study the feasibility and efficacy of VR to decrease experienced pain and anxiety in patients undergoing invasive procedures for arrhythmias and conduction disorders. The study also serves as a stepping stone towards structural implementation of VR into clinical care, by familiarizing care personnel of the cardiac catheterization rooms with the use of VR, its indications and logistics, and identifying potential barriers for structural implementation of VR.
Study design: VR inEP is a single-center, open label, randomized controlled trial performed in the catheterization rooms in the Radboudumc.
Study population: Adult patients undergoing an electrophysiological procedure (e.g., catheter ablation or electrophysiological study) or cardiac device implantation (e.g., pacemaker or implantable cardioverter defibrillator) performed under local anesthesia are eligible for inclusion.
Intervention: Patients consenting to participate are randomized in a 1:1 ratio to the VR intervention or control group, stratified for the indication for the procedure (50% electrophysiological procedures, 50% cardiac device implantations). Patients and their treatment teams are unblinded for the treatment allocation.
Main study parameters: The primary outcomes are pain perception and anxiety during the procedure as a whole, quantified using the visual analogue scale (VAS) for pain and the numeric ranking scale (NRS) for anxiety, 30 minutes after the procedure ends.
- Conditions
- Arrhythmia, Cardiac Implantable Electronic Device, Ablation of Arrhythmias, Electrophysiologic Study, Pacemaker, ICD
- Being tested
- VR therapy, 360 degree education videos
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR therapyOther
Also called VR relax and distract, VR relax & distract, Virtual reality
Patients in the VR intervention group receive a VR 'relax and distract' intervention in addition to standard care. This type of VR utilizes video's, relaxation exercises and cognitive games to immerse patients in a novel, calming and distracting environment, enhancing the patient's ability to manage anxiety, stress and pain. The VR set is introduced to the patient in the cardiology day care unit prior to the procedure allowing for familiarization with the device. After moving the patient to the catheterization laboratory, the VR set is re-offered to the patient and the VR intervention is started. The intervention ends with the conclusion of the procedure, or when the patient indicates that they would like to discontinue the therapy earlier.
360 degree education videosOther
Prior to the procedure, patients in the VR intervention group are additionally offered an educational video consisting of a virtual tour of the EP laboratory with a visual explanation of the upcoming procedure. These videos will be recorded as 360ͦ videos to support an optimal immersive experience when viewed on the VR set. In this way, the videos will serve simultaneously as additional educational measures for the procedure, as well as a way to familiarize patients with the VR set. Use of the educational videos is not obligatory, but is offered optionally according to patients' preference.
| Study group | Role | What they receive |
|---|---|---|
| VR therapy | Experimental | Not described Receives: Other: VR therapy; Other: 360 degree education videos |
| Control group | No intervention | The control group is treated according to the local protocol, which may encompass preprocedural administration of benzodiazepines or analgesics depending on the procedure type and indication, nurses' assessment, patient preference, comorbidities, and medication use. These medications will be administered after randomization and baseline assessment of anxiety and pain. If required during the procedure, additional analgesics may be administered (usually fentanyl). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain perception
Pain perception during the procedure as a whole, quantified using the visual analogue scale (VAS, 0-10 points) 30 minutes after the procedure ends.
Measured: 0.5-6 hours
Anxiety
The second primary outcome is anxiety during the procedure as a whole, quantified using the numeric ranking scale (NRS, 0-10 points) 30 minutes after the procedure ends.
Measured: 0.5-6 hours
Secondary outcomes (11)
Use of analgesics
Measured: 0.5-6 hours
Self-reported acceptable pain
Self-reported answer, provided in custom made questionnaire (yes/no)
Measured: 0.5-6 hours
Worst pain
Measured on the Visual Analogue Scale
Measured: 0.5-6 hours
Time experience
Self-reported answer by patients, provided in custom made questionnaire (expected number of hours/minutes duration of the procedure)
Measured: 0.5-6 hours
Heart rate variability
Measured: 0.5-6 hours
Procedural duration
Measured: 0.5-6 hours
Duration of hospital admission after finalization of the procedure
Measured: 0-7 days
Time of VR use as a percentage of total procedural duration
Measured: 0.5-6 hours
Patient satisfaction with the VR therapy and the optional educational video
Score from 0-10, where 10 is the highest value/satisfaction
Measured: 0.5-10 hours
Procedural satisfaction of health care professionals with VR
Satisfaction score from 0-10, where 10 is the highest value/satisfaction
Measured: 0.5-10 hours
Number of patients with complications
Measured: 0.5-6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start15 Nov 2025 (estimated)
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArrhythmiaStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Netherlands Heart Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07105241
- Sponsor's protocol ID
- NL-010331
- Acronym
- VR inEP
- Status last verified
- Jul 2025
- First submitted
- 10 Jul 2025
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality in Electrophysiological Procedures and Device Implantation: the VR inEP Trial
- ClinicalTrials.gov ID
- NCT07105241
- Acronym / sponsor ID
- VR inEP / NL-010331
- Conditions
- Arrhythmia, Cardiac Implantable Electronic Device, Ablation of Arrhythmias, Electrophysiologic Study, Pacemaker, ICD
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Netherlands Heart Foundation
- Study start
- 15 Nov 2025 (estimated)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 5 Aug 2025 (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.
Each year about 37,000 patients undergo a catheter ablation to treat cardiac arrhythmias or have a cardiac device such as a pacemaker or implantable cardioverter defibrillator implanted in the Netherlands. Although the procedures positively impact health related outcomes on the long term, they are often accompanied by periprocedural pain and anxiety on a shorter term. These negative effects can be prevented or treated by pharmacological interventions (e.g. analgesics or benzodiazepines), but side effects of these drugs may compromise patient safety and extend hospital admissions. Distraction using Virtual Reality (VR) may be an attractive non-pharmacological alternative.
It is the aim of the Virtual Reality in Electrophysiological Procedures and device implantation (VR inEP) trial to study the feasibility and efficacy of VR to decrease experienced pain and anxiety in patients undergoing invasive procedures for arrhythmias and conduction disorders. The study also serves as a stepping stone towards structural implementation of VR into clinical care, by familiarizing care personnel of the cardiac catheterization rooms with the use of VR, its indications and logistics, and identifying potential barriers for structural implementation of VR.
VR inEP is a single-center, open label, randomized controlled trial performed in the catheterization rooms in the Radboudumc. Adult patients undergoing an electrophysiological procedure (e.g., catheter ablation or electrophysiological study) or cardiac device implantation (e.g., pacemaker or implantable cardioverter defibrillator) performed under local anesthesia are eligible for inclusion. Patients consenting to participate are randomized in a 1:1 ratio to the VR intervention or control group, stratified for the indication for the procedure (50% electrophysiological procedures, 50% cardiac device implantations). Patients and their treatment teams are unblinded for the treatment allocation. The primary outcomes are pain perception and anxiety during the procedure as a whole, quantified using the visual analog scale (VAS) for pain and the numeric ranking scale (NRS) for anxiety, 30 minutes after the procedure ends.
Detailed description
Rationale: Each year approximately 37,000 patients undergo a catheter ablation or cardiac device implantation in The Netherlands. Although the procedures positively impact health related outcomes, they are often accompanied by periprocedural pain and anxiety. These negative effects can be prevented or treated by pharmacological interventions (e.g. analgesics or benzodiazepines), but side effects of these drugs may compromise patient safety and extend hospital admissions. Distraction using Virtual Reality (VR) may be an attractive non-pharmacological alternative.
Objective: it is the aim of the Virtual Reality in Electrophysiological Procedures and device implantation (VR inEP) trial to study the feasibility and efficacy of VR to decrease experienced pain and anxiety in patients undergoing invasive procedures for arrhythmias and conduction disorders. The study also serves as a stepping stone towards structural implementation of VR into clinical care, by familiarizing care personnel of the cardiac catheterization rooms with the use of VR, its indications and logistics, and identifying potential barriers for structural implementation of VR.
Study design: VR inEP is a single-center, open label, randomized controlled trial performed in the catheterization rooms in the Radboudumc.
Study population: Adult patients undergoing an electrophysiological procedure (e.g., catheter ablation or electrophysiological study) or cardiac device implantation (e.g., pacemaker or implantable cardioverter defibrillator) performed under local anesthesia are eligible for inclusion.
Intervention: Patients consenting to participate are randomized in a 1:1 ratio to the VR intervention or control group, stratified for the indication for the procedure (50% electrophysiological procedures, 50% cardiac device implantations). Patients and their treatment teams are unblinded for the treatment allocation.
Main study parameters: The primary outcomes are pain perception and anxiety during the procedure as a whole, quantified using the visual analogue scale (VAS) for pain and the numeric ranking scale (NRS) for anxiety, 30 minutes after the procedure ends.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR therapy | Experimental | Other: VR therapy, Other: 360 degree education videos |
| Control group | No intervention | –The control group is treated according to the local protocol, which may encompass preprocedural administration of benzodiazepines or analgesics depending on the procedure type and indication, nurses' assessment, patient preference, comorbidities, and medication use. These medications will be administered after randomization and baseline assessment of anxiety and pain. If required during the procedure, additional analgesics may be administered (usually fentanyl). |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- ≥16 years of age
- Planned to undergo an invasive electrophysiological procedure (e.g., catheter ablation or electrophysiological study) or cardiac device implantation (e.g., pacemaker or implantable cardioverter defibrillator).
- The procedure must be performed under local anesthesia.
Key exclusion criteria (4 listed)
- Patients undergoing procedures using (conscious) sedation
- Patients who do not speak or understand Dutch
- History of dementia
- Severe visual impairment.
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 therapyAlso: VR relax and distract, VR relax & distract, Virtual realityPatients in the VR intervention group receive a VR 'relax and distract' intervention in addition to standard care. This type of VR utilizes video's, relaxation exercises and cognitive games to immerse patients in a novel, calming and distracting environment, enhancing the patient's ability to manage anxiety, stress and pain. The VR set is introduced to the patient in the cardiology day care unit prior to the procedure allowing for familiarization with the device. After moving the patient to the catheterization laboratory, the VR set is re-offered to the patient and the VR intervention is started. The intervention ends with the conclusion of the procedure, or when the patient indicates that they would like to discontinue the therapy earlier. | Other | VR therapy |
| 360 degree education videosPrior to the procedure, patients in the VR intervention group are additionally offered an educational video consisting of a virtual tour of the EP laboratory with a visual explanation of the upcoming procedure. These videos will be recorded as 360ͦ videos to support an optimal immersive experience when viewed on the VR set. In this way, the videos will serve simultaneously as additional educational measures for the procedure, as well as a way to familiarize patients with the VR set. Use of the educational videos is not obligatory, but is offered optionally according to patients' preference. | Other | VR therapy |
Primary outcome
Pain perception
Time frame: 0.5-6 hours
Pain perception during the procedure as a whole, quantified using the visual analogue scale (VAS, 0-10 points) 30 minutes after the procedure ends.
Anxiety
Time frame: 0.5-6 hours
The second primary outcome is anxiety during the procedure as a whole, quantified using the numeric ranking scale (NRS, 0-10 points) 30 minutes after the procedure ends.
11 secondary outcomes
Use of analgesics
Time frame: 0.5-6 hours
Self-reported acceptable pain
Time frame: 0.5-6 hours
Worst pain
Time frame: 0.5-6 hours
Time experience
Time frame: 0.5-6 hours
Heart rate variability
Time frame: 0.5-6 hours
Procedural duration
Time frame: 0.5-6 hours
Duration of hospital admission after finalization of the procedure
Time frame: 0-7 days
Time of VR use as a percentage of total procedural duration
Time frame: 0.5-6 hours
Patient satisfaction with the VR therapy and the optional educational video
Time frame: 0.5-10 hours
Procedural satisfaction of health care professionals with VR
Time frame: 0.5-10 hours
Number of patients with complications
Time frame: 0.5-6 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing VR therapy and 360 degree education videos in people with Arrhythmia and Cardiac Implantable Electronic Device, run by Radboud University Medical Center.
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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 5 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dominique VM Verhaert, MD PhD (+3124 - 36 16785, dominique.verhaert@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain perception (time frame: 0.5-6 hours). The study lists 2 primary outcomes in all. 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 5 Aug 2025.