Impact of Virtual Reality in Cardiac Electrophysiology

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-01

Study Completion Date

2025-12-31

Brief Summary

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Pain during pacemaker or defibrillator implantation can increase patient discomfort, anxiety, and the need for deeper sedation. Using virtual reality (VR) as a non-pharmacological distraction tool may help reduce perceived pain, stabilize vital signs, and improve the overall patient experience. This prospective, single-center study evaluates whether adding VR to standard sedation lowers pain levels compared to sedation alone. Patients undergoing device implantation will be randomized to either group, with pain and vital signs monitored throughout the procedure. The study also explores patient satisfaction, adverse effects, and the potential of VR to support same-day discharge after minimally invasive procedures.

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Detailed Description

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Conditions

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Pain, Acute

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Virtual reality Group

Patients who receive a virtual reality headset that provides an immersive environment, such as natural landscapes accompanied by relaxing music. The use of VR will begin at least five minutes before the start of the procedure to allow the patient to acclimate. The headset will remain in use throughout the entire procedure, unless complications arise (e.g., nausea or significant discomfort).

Virtual reality

Intervention Type DEVICE

VR headset provides an immersive environment, such as natural landscapes accompanied by relaxing music. The use of VR will begin at least five minutes before the start of the procedure to allow the patient to acclimate. The headset will remain in use throughout the entire procedure, unless complications arise (e.g., nausea or significant discomfort).

Control Group (Standard Sedation)

Patients who receive standard sedation (e.g. midazolam and/or fentanyl at the operator's discretion, according to hospital protocol), in accordance with comfort and analgesia guidelines for cardiac pacing procedures.

No interventions assigned to this group

Interventions

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Virtual reality

VR headset provides an immersive environment, such as natural landscapes accompanied by relaxing music. The use of VR will begin at least five minutes before the start of the procedure to allow the patient to acclimate. The headset will remain in use throughout the entire procedure, unless complications arise (e.g., nausea or significant discomfort).

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years.
* Patients who are candidates for pacemaker (PM) or implantable cardioverter-defibrillator (ICD) implantation, including new devices such as leadless PM and subcutaneous ICD (S-ICD).
* Ability to provide written informed consent.
* Ability to understand the use of the VR headset and express a pain score using the NRS scale.

Exclusion Criteria

* Severe cognitive, psychiatric or neurological disorders that impair understanding or collaboration in the study.
* Visual and/or auditory and inner ear disorders or severe vertigo that could be aggravated by VR.
* Allergies or known adverse reactions to standard sedative therapies provided for in the protocol (e.g. midazolam) if essential for the procedure.
* Inability to correctly position the VR headset (e.g. severe facial deformities, recent trauma to the craniofacial area).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No