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

Overview

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.

Interventions

• Other VR therapy
  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
• Other 360 degree education videos
  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 e

Primary outcome measures

• Pain perception [Time frame: 0.5-6 hours]
• Anxiety [Time frame: 0.5-6 hours]

Secondary outcome measures (11)

• 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07105241 · NL-010331

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗