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

May 31, 2026 updated by: Muhammed Kurt

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

111

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • North Rhine-Westphalia
      • Essen, North Rhine-Westphalia, Germany, 45147
        • West german heart and vascular center, University hospital Essen,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
The patients in control arm received the standard preoperative care using local anesthesia and on-demand conscious sedation
Experimental: intervention group
The patients in intervention arm received a virtual reality headset in addition to the standard care
Other: Virtual reality headset
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From enrolment to immediate postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Muhammed Kurt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Actual)

May 1, 2025

Study Completion (Actual)

November 1, 2025

Study Registration Dates

First Submitted

November 17, 2025

First Submitted That Met QC Criteria

November 23, 2025

First Posted (Actual)

November 26, 2025

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

May 31, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-11442-BO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain

Clinical Trials on Virtual reality headset

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Latvia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe