Virtual Reality in Electrophysiological Procedures and Device Implantation: the VR inEP Trial

Radboud University Medical Center

Status: Not yet enrolling

Conditions: Ablation of Arrhythmias; Electrophysiologic Study; Arrhythmia; Cardiac Implantable Electronic Device; Pacemaker; ICD

Treatments: Other: 360 degree education videos; Other: VR therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07105241

NL-010331

Details and patient eligibility

About

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.

Full 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.

Enrollment: 115 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ≥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.

Exclusion criteria

• Patients undergoing procedures using (conscious) sedation
• Patients who do not speak or understand Dutch
• History of dementia
• Severe visual impairment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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115 participants in 2 patient groups

VR therapy

Experimental group

Treatment:

Other: VR therapy

Other: 360 degree education videos

Control group

No Intervention group

Description:

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).