Symptoms and Coping Strategies Among Patients With Implantable Cardioverter Defibrillator

NCT07121855 | Completed

• 1 other identifier: Adana
• Study Type: observational
• Target: 142
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Sudden Cardiac Arrest; Ventricular Arrhythmias

Keywords

Implantable Defibrillators; Symptoms; Self Care; Arrhythmias; Symptom Management

Outcome Measures

Primary Outcomes (2)

• Types and frequencies of symptoms

  Types and frequencies of physical and psychological symptoms reported by patients with implantable cardioverter defibrillator (ICDs)

  Baseline

• Types and frequencies of coping strategies

  Types and frequencies of coping strategies used by ICD patients to manage their symptoms

  Baseline

Study Arms (1)

Patients with implantable cardioverter defibrillators (ICDs)

Patients who have had an implantable cardioverter defibrillator (ICD) implanted at least 3 months prior

Eligibility Criteria

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

Study Population

ICD patients

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Turkish Ministry of Health, Adana City Training and Research Hospital

Sinop, Sinop, 57000, Turkey (Türkiye)

Location

Related Publications (11)

• Polikandrioti M, Tzirogiannis K, Zyga S, Gerogianni G, Stefanidou S, Tsami A, Panoutsopoulos G. Assessment of fatigue in patients with a permanent cardiac pacemaker: prevalence and associated factors. Arch Med Sci Atheroscler Dis. 2018 Dec 20;3:e166-e173. doi: 10.5114/amsad.2018.81085. eCollection 2018.

  PMID: 30775608 BACKGROUND

• Polikandrioti M, Tzirogiannis K, Zyga S, Koutelekos I, Vasilopoulos G, Theofilou P, Panoutsopoulos G. Effect of anxiety and depression on the fatigue of patients with a permanent pacemaker. Arch Med Sci Atheroscler Dis. 2018 Feb 5;3:e8-e17. doi: 10.5114/amsad.2018.73231. eCollection 2018.

  PMID: 30775584 BACKGROUND

• Pasyar N, Rambod M, Nikoo MH, Mansouri P. An Evaluation of the Association between Quality of Life and Psychological Issues in Patients with Automated Implantable Cardioverter Defibrillator. J Caring Sci. 2021 Nov 6;11(1):28-35. doi: 10.34172/jcs.2022.01. eCollection 2022 Mar.

  PMID: 35603084 BACKGROUND

• Magnusson P, Mattsson G, Wallhagen M, Karlsson J. Health-related quality of life in patients with implantable cardioverter defibrillators in Sweden: a cross-sectional observational trial. BMJ Open. 2021 Jul 9;11(7):e047053. doi: 10.1136/bmjopen-2020-047053.

  PMID: 34244266 BACKGROUND

• Sun Y, Yu Z. Anxiety and depression in a patient with an implantable cardioverter defibrillator for early repolarization syndrome: A case report and clinical discussion. Journal of Clinical and Basic Psychosomatics. 2024;2(3):2848.

  BACKGROUND

• Rambod M, Rohaninasab S, Pasyar N, Nikoo MH. The effect of virtual interactive nurse-led support group intervention on fatigue, shock anxiety, and acceptance of implantable cardioverter defibrillator patients: a randomized trial. BMC Cardiovasc Disord. 2024 Jan 11;24(1):40. doi: 10.1186/s12872-024-03713-5.

  PMID: 38212701 BACKGROUND

• Spar DS, Bianco NR, Knilans TK, Czosek RJ, Anderson JB. The US Experience of the Wearable Cardioverter-Defibrillator in Pediatric Patients. Circ Arrhythm Electrophysiol. 2018 Jul;11(7):e006163. doi: 10.1161/CIRCEP.117.006163.

  PMID: 29945928 BACKGROUND

• Sert, M. (2019). İpmplante edilebilir kardiyoverter defibrilatörü olan hastalarda ölüm kaygısı ve uyku kalitesi. Turk J Cardiovasc Nurs 2019;10(22):78-86.

  BACKGROUND

• da Silva KR, Costa R, Rodrigues CG, Schasechter A, Nobre MC, Passman R, Mark DB. Quality of life in patients with implantable cardioverter-defibrillator: systematic review of randomized controlled trials. Eur J Cardiovasc Nurs. 2018 Mar;17(3):196-206. doi: 10.1177/1474515117739619. Epub 2017 Oct 25.

  PMID: 29067836 BACKGROUND

• Bozat A.D. (2019). Kalp İçi Defibrillatör Ve Kalıcı Kalp Pili Kullanan Çocuk, Ergen Ve Ailelerinde Dayanıklılık, Yaşam Kalitesi Ve Psikiyatrik Semptomların Değerlendirilmesi. (Uzmanlık Tezi, Hacettepe Üniversitesi Tıp Fakültesi Çocuk Sağlığı Ve Hastalıkları Anabilim Dalı).

  BACKGROUND

• Forman J, Baumbusch J, Jackson H, Lindenberg J, Shook A, Bashir J. Exploring the patients' experiences of living with a subcutaneous implantable cardioverter defibrillator. Eur J Cardiovasc Nurs. 2018 Dec;17(8):698-706. doi: 10.1177/1474515118777419. Epub 2018 May 18.

  PMID: 29775072 BACKGROUND

MeSH Terms

Conditions

Heart Failure; Death, Sudden, Cardiac; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Heart Arrest; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sultan Taşcı, Professor

  TC Erciyes University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse Specialist

Study Record Dates

• First Submitted: August 2, 2025
• First Posted: August 14, 2025
• Study Start: May 1, 2022
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)