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

NCT07250282 | Completed

• 1 other identifier: 23-11442-BO
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anxiety; Pain

Keywords

CIED; Pacemaker; Virtual reality; ICD; CRT

Outcome Measures

Primary Outcomes (1)

• Baseline to perioperative anxiety change using State-Trait Anxiety Inventory-State (STAI-S) questionnaire score pre- and periprocedurally (Score range between 20 - 80, higher score means greater state anxiety)

  The anxiety reduction of patients from preprocedural to periprocedural state defined as reduction in STAI-S Scores pre and periprocedural was compared between the groups as the primary endpoint of the study

  From enrolment to the first postoperative day

Study Arms (2)

Control group

NO INTERVENTION

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

intervention group

EXPERIMENTAL

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

Other: Virtual reality headset

Interventions

Virtual reality headset OTHER

A virtual reality headset was used during the study with the purpose of distracting the patients from painful and stressful stimuli in the operation room to decrease their anxiety and pain perception

intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Muhammed Kurt: lead

Study Sites (1)

West german heart and vascular center, University hospital Essen,

Essen, North Rhine-Westphalia, 45147, Germany

Location

MeSH Terms

Conditions

Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Attending physician, Department of Cardiology and Vascular Medicine, University Hospital Essen

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 26, 2025
• Study Start: January 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: May 1, 2025
• Last Updated: November 26, 2025

Record last verified: 2025-11

Locations

DE (1)