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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

West german heart and vascular center, University hospital Essen,

Essen, North Rhine-Westphalia, 45147, Germany

About this study

Methods:

From January 2024 to Mai 2025, 111 Patients undergoing implantation of cardiac single-chamber or dual-chamber pacemakers or defibrillators and cardiac resynchronisation therapy were randomized to either a control group (n=55) or an intervention group (n=56). The control group received standard preoperative care using local anaesthesia and on-demand conscious sedation. A virtual reality headset was used in the intervention group in addition to the standard care intraoperatively. The State-Trait Anxiety Inventory-State (STAI-S) questionnaire was filled out by patients preoperative and immediate postoperative to best determine their perioperative state anxiety.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Significant language barrier preventing consent or cooperation
severe panic disorder or claustrophobia

Treatment and study plan

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

Primary outcomes

Preoperative baseline to immediate postoperative anxiety change using State-Trait Anxiety Inventory-State (STAI-S) questionnaire score (Score range between 20 - 80, higher score means greater state anxiety)

Time frame: From enrolment to immediate postoperative

The perioperative anxiety change of patients defined as reduction in STAI-S anxiety scores from preoperative to immediate postoperative was compared between the groups as the primary endpoint of the study

Sponsors and collaborators

Lead sponsor

Muhammed Kurt

Other

Registry information

Official study title

Impact of Virtual Reality on Patients' Anxiety and Pain During Implantation of Cardiac Pacemakers, Implantable Cardioverter-defibrillators, or Cardiac Resynchronization Therapy: a Randomized Controlled Study

Acronym: CIED

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Nov 26, 2025
Registry last updated: Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed