Heart FailureICDNCT07121855
Symptoms and Coping Strategies Among Patients With Implantable Cardioverter Defibrillator
An observational study of Heart Failure and Sudden Cardiac Arrest, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Sudden Cardiac Arrest, Ventricular Arrhythmias
- How many people
- 142 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2022to 1 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ICD patients
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Turkish Ministry of Health, Adana City Training and Research Hospital
Sinop, Sinop, 57000
About this study
Official title: Symptoms and Coping Strategies Among Patients With Implantable Cardioverter Defibrillators
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.
Read the 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.
- Keywords
- Implantable Defibrillators, Symptoms, Self Care, Arrhythmias, Symptom Management
- Medical subject headings
- Heart Failure, Death, Sudden, Cardiac, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with implantable cardioverter defibrillators (ICDs) | Patients who have had an implantable cardioverter defibrillator (ICD) implanted at least 3 months prior |
What is being measured
The primary outcome is the main question the study is designed to answer.
Types and frequencies of symptoms
Types and frequencies of physical and psychological symptoms reported by patients with implantable cardioverter defibrillator (ICDs)
Measured: Baseline
Types and frequencies of coping strategies
Types and frequencies of coping strategies used by ICD patients to manage their symptoms
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start1 May 2022
- Primary completion1 Aug 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sebiha Aktaş Us, TC Erciyes University
- Investigators
- Sultan Taşcı, Professor, Study director, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07121855
- Sponsor's protocol ID
- Adana
- Acronym
- ICD
- Status last verified
- Aug 2025
- First submitted
- 2 Aug 2025
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not applicable. No individual participant data (IPD) will be shared.
Publications
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.
PubMed 35603084Magnusson 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.
PubMed 34244266Sun 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.
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.
PubMed 38212701Spar 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.
PubMed 29945928Sert, M. (2019). İpmplante edilebilir kardiyoverter defibrilatörü olan hastalarda ölüm kaygısı ve uyku kalitesi. Turk J Cardiovasc Nurs 2019;10(22):78-86.
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.
PubMed 29067836Bozat 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).
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.
PubMed 30775608Polikandrioti 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.
PubMed 30775584Forman 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.
PubMed 29775072
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptoms and Coping Strategies Among Patients With Implantable Cardioverter Defibrillators
- ClinicalTrials.gov ID
- NCT07121855
- Acronym / sponsor ID
- ICD / Adana
- Keywords
- Implantable Defibrillators, Symptoms, Self Care, Arrhythmias, Symptom Management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 14 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with implantable cardioverter defibrillators (ICDs) | – | –Patients who have had an implantable cardioverter defibrillator (ICD) implanted at least 3 months prior |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ICD patients
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Types and frequencies of symptoms
Time frame: Baseline
Types and frequencies of physical and psychological symptoms reported by patients with implantable cardioverter defibrillator (ICDs)
Types and frequencies of coping strategies
Time frame: Baseline
Types and frequencies of coping strategies used by ICD patients to manage their symptoms
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Background: PubMed 35603084Pasyar 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.
- Background: PubMed 34244266Magnusson 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.
- BackgroundSun 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: PubMed 38212701Rambod 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.
- Background: PubMed 29945928Spar 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.
- BackgroundSert, M. (2019). İpmplante edilebilir kardiyoverter defibrilatörü olan hastalarda ölüm kaygısı ve uyku kalitesi. Turk J Cardiovasc Nurs 2019;10(22):78-86.
- Background: PubMed 29067836da 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.
- BackgroundBozat 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).
- Results publication: PubMed 30775608Polikandrioti 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.
- Results publication: PubMed 30775584Polikandrioti 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.
- Results publication: PubMed 29775072Forman 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.
- Individual participant dataSharing planned: No. Not applicable. No individual participant data (IPD) will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sultan Taşcı, Professor study director
TC Erciyes University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Sudden Cardiac Arrest, run by TC Erciyes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Types and frequencies of symptoms (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07121855, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.