Symptoms and Coping Strategies Among Patients With Implantable Cardioverter Defibrillator

Completed

• Conditions: Heart Failure; Sudden Cardiac Arrest; Ventricular Arrhythmias

• Registration Number: NCT07121855
• Lead Sponsor: TC Erciyes University

Brief Summary

Implantable cardioverter defibrillators (ICDs) are widely used to prevent sudden cardiac death in patients with serious arrhythmias and significantly increase survival rates. However, living with an ICD can bring about a range of physical symptoms, such as palpitations, fatigue, and chest discomfort, as well as psychological challenges like anxiety, fear of shock, and uncertainty about the future. These symptoms can negatively impact patients' quality of life and daily functioning. As a result, how patients cope with these experiences becomes an important component of long-term well-being. Despite advancements in device technology, many patients continue to experience emotional and behavioral adjustment challenges. Researching patients' symptom experiences and coping strategies is essential for developing supportive, non-pharmacological interventions that address both physical and emotional needs. This study aims to identify the most common symptoms associated with ICD and investigate the methods patients use to manage them in their daily lives.

Detailed Description

Implantable cardioverter defibrillators (ICDs) are widely used medical devices designed to prevent sudden cardiac death in patients with life-threatening ventricular arrhythmias. Although ICD therapy has significantly improved survival rates in high-risk heart patients, its presence can introduce new physical and psychological challenges that may impact daily life. Patients living with an ICD often report various symptoms such as palpitations, fatigue, chest discomfort, and sleep disturbances. In addition to these physical symptoms, psychological distress such as anxiety, fear of shock, and uncertainty about the future is also commonly observed.

Transitioning to life with an ICD requires not only physiological adaptation but also emotional and behavioral adjustment. How patients perceive the presence of the device and how they cope with it plays a critical role in their overall quality of life. While technological advancements have reduced inappropriate shocks and device-related complications, the psychosocial burden remains significant for many patients. As a result, coping strategies, particularly non-pharmacological approaches, have become essential tools for managing stress associated with ICDs and maintaining psychological balance.

Despite the increasing number of ICD recipients, there remains a gap in the literature regarding the specific symptoms experienced post-implantation and the individual coping mechanisms employed by patients. Investigating these dimensions could provide healthcare providers with insights into the ongoing needs of ICD patients and guide the development of supportive interventions that address both physical symptoms and emotional responses.

This study aims to identify the most common symptoms among ICD patients and investigate the methods they use to cope with these symptoms. By better understanding patient experiences, clinicians can provide more comprehensive and patient-centered care tailored to this unique population.

Study Timeline

• Study Start: 2022-05-01
• Primary Completion: 2022-08-01
• Study Completion: 2022-08-01
• Status Verified: 2025-08
• Study First Submitted: 2025-08-02
• Study First Submitted QC: 2025-08-07
• Last Update Submitted: 2025-08-07
• Study First Posted: 2025-08-14
• Last Update Posted: 2025-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 142

Inclusion Criteria

• Participants were informed about the study and provided informed consent to participate voluntarily,
• Patients who had an ICD implanted at least 3 months prior to the study,
• Patients with no communication difficulties (speak Turkish, no mental retardation),
• Adult patients aged 18 years or older.

Exclusion Criteria

• Patients who are unable to provide informed consent regarding the study
• Patients who have undergone ICD implantation less than 3 months prior
• Patients who have difficulty communicating
• Patients under the age of 18
• Patients whose symptoms cannot be directly attributed to the ICD due to serious physical illness

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Types and frequencies of symptoms	Baseline	Types and frequencies of physical and psychological symptoms reported by patients with implantable cardioverter defibrillator (ICDs)
Types and frequencies of coping strategies	Baseline	Types and frequencies of coping strategies used by ICD patients to manage their symptoms

Trial Locations

Locations (1)

Turkish Ministry of Health, Adana City Training and Research Hospital; 🇹🇷 Sinop, Turkey