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

Not Applicable

Not yet recruiting

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

• Registration Number: NCT07105241
• Lead Sponsor: Radboud University Medical Center

Brief 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. 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 Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-10
• Study First Submitted QC: 2025-07-29
• Last Update Submitted: 2025-07-29
• Study First Posted: 2025-08-05
• Last Update Posted: 2025-08-05
• Study Start: 2025-11-15
• Primary Completion: 2026-07-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 115

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain perception	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	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.

Secondary Outcome Measures

Name	Time	Method
Use of analgesics	0.5-6 hours
Self-reported acceptable pain	0.5-6 hours	Self-reported answer, provided in custom made questionnaire (yes/no)
Worst pain	0.5-6 hours	Measured on the Visual Analogue Scale
Time experience	0.5-6 hours	Self-reported answer by patients, provided in custom made questionnaire (expected number of hours/minutes duration of the procedure)
Heart rate variability	0.5-6 hours
Procedural duration	0.5-6 hours
Duration of hospital admission after finalization of the procedure	0-7 days
Time of VR use as a percentage of total procedural duration	0.5-6 hours
Patient satisfaction with the VR therapy and the optional educational video	0.5-10 hours	Score from 0-10, where 10 is the highest value/satisfaction
Procedural satisfaction of health care professionals with VR	0.5-10 hours	Satisfaction score from 0-10, where 10 is the highest value/satisfaction
Number of patients with complications	0.5-6 hours