Impact of Virtual Reality on Anxiety and Pain During Implantation of Cardiac Implantable Electronic Devices (CIED)

Muhammed Kurt

Status: Completed

Conditions: Anxiety; Pain

Treatments: Other: Virtual reality headset

Study type: Interventional

Funder types: Other

Identifiers

NCT07250282

23-11442-BO

Details and patient eligibility

About

Purpose:

This study aimed to evaluate whether virtual reality technology positively affects patients' pain and anxiety throughout the entire procedure of implantation of cardiac pacemakers, defibrillators, or cardiac resynchronisation therapy.

Full description

Methods:

From January 2024 to Mai 2025, 100 Patients undergoing implantation of cardiac single-chamber or dual-chamber pacemakers or defibrillators and cardiac resynchronisation therapy were included in this study. Patients were randomly assigned to either a control group (n=50) or an intervention group (n=50). The control group received standard preoperative care and local anaesthesia using lidocaine. A virtual reality headset was used in the intervention group in addition to the standard preoperative care and local anaesthesia during the procedure. The procedure was performed in all patients using standard preparation and cephalic vein cutdown. The State-Trait Anxiety Inventory-State (STAI-S) questionnaire was filled out by patients pre- and postoperatively to determine their anxiety levels before and during the procedure.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• Age ≥ 18 years
• Indication for implantation of a cardiac pacemaker, ICD, or CRT device due to one of the following:
• Complete heart block (AV block III°)
• Symptomatic bradycardia due to sinus node dysfunction
• Tachy-brady syndrome
• Atrial fibrillation with slow ventricular rate
• Symptomatic bradycardia due to AV block II° type Mobitz
• Secondary prevention of sudden cardiac death due to ventricular tachycardia
• Primary prevention in patients with heart failure with reduced ejection fraction
• Primary prevention in patients with heart failure with reduced ejection fraction and complete left bundle branch block
• "Pace and ablate" strategy for therapy-resistant persistent atrial fibrillation
• Need to Upgrade to CRT-P due to a high percentage of right ventricular pacing

Exclusion Criteria:

• Intolerance or inability to wear the VR headset
• Significant language barrier preventing consent or cooperation
• Need for deep sedation or general anesthesia for the procedure

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Control group

No Intervention group

Description:

The patients in control arm received the standard preoperative care using local anesthesia

intervention group

Experimental group

Description:

The patients in intervention arm received a virtual reality headset in addition to the standard care using local anesthesia

Treatment:

Other: Virtual reality headset