Ablation of Arrhythmias, Arrhythmia, Cardiac Implantable Electronic Device, Electrophysiologic Study, ICD, Pacemaker
Conditions
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.
Interventions
OTHERVR 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 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.
OTHER360 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 educational videos is not obligatory, but is offered optionally according to patients' preference.
Sponsors
Netherlands Heart Foundation
Radboud University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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) |
| Heart rate variability | 0.5-6 hours | — |
| 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) |
| 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 | — |
| Worst pain | 0.5-6 hours | Measured on the Visual Analogue Scale |
| Procedural duration | 0.5-6 hours | — |
Contacts
Primary ContactDominique VM Verhaert, MD PhD
Outcome results
None listed