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Recruiting NCT07343466

Quality of Life and the Influence of Stress on the Postoperative Course of Patients After Device Implantation

— Observational Quality of Life (QOL) and Impact of Stress

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Survey using a questionnaire..
Who it may be relevant to
Registry conditions: Quality of Life (QOL) and Impact of Stress. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Klinische Studie Zur Untersuchung Der Lebensqualität Und Des Einflusses Von Stress Auf Den Postoperativen Verlauf Von Patienten Nach Device-Implantation

Overview

The project "Investigating Quality of Life and the Influence of Stress on the Postoperative Course of Patients After Device Implantation" aims to investigate the relationship between stress and the postoperative healing process of patients who have had a medical device implanted. These devices include pacemakers for the treatment of bradycardia, implantable cardioverter-defibrillators (ICDs) for the treatment of tachycardia in primary and secondary prevention, and cardiac resynchronization therapy (CRT) devices and event recorders. The study will analyze the influence of stress on the postoperative course, potential complications, and overall quality of life. A combination of medical examinations and surveys will be used to analyze how psychological stress influences the physical healing process and which measures can contribute to improving quality of life and treatment success. The surgical procedure for implanting devices is not part of the study; this is an observational study.

Interventions

  • Other Survey using a questionnaire.
    survery over 36 months with comparison of the questionnares with risk-factors, blood-samples and physical fitness of the patient

Primary outcome measures

  • Cumulative incidence of device-related complications [Time frame: 36 Months]
Secondary outcome measures (12)
  • hospitalisation rate [Time frame: 36 Months]
  • Number of participants with the following arrhythmic events: ventrikular tachykardia and ventrikular fibrillation [Time frame: Baseline, after 4-6 weeks, after 6 months, after 12 months, after 18 months, after 24 months, after 30 months, after 36 months]
  • Changes in functional capacity [Time frame: Baseline (at 4-6 weeks) , after 6 months, after 12 months, after 18 months, after 24 months, after 30 months, after 36 months]
  • combined global stress measure [Time frame: Baseline, after 4-6 weeks, after 6 months, after 12 months, after 18 months, after 24 months, after 30 months, after 36 months]
  • Health-related quality of life - SF-36 [Time frame: Baseline, after 4-6 weeks, after 6 months, after 12 months, after 18 months, after 24 months, after 30 months, after 36 months]
  • Health-related Quality of life - EQ-5D-5L [Time frame: Baseline, after 4-6 weeks, after 6 months, after 12 months, after 18 months, after 24 months, after 30 months, after 36 months]
  • Health-related Quality of life - VAS for general health [Time frame: Baseline, after 4-6 weeks, after 6 months, after 12 months, after 18 months, after 24 months, after 30 months, after 36 months]
  • Depression symptoms (BDI-II) [Time frame: Baseline, after 4-6 weeks, after 6 months, after 12 months, after 18 months, after 24 months, after 30 months, after 36 months]
  • Anxiety symptoms (STAI) [Time frame: Baseline, after 4-6 weeks, after 6 months, after 12 months, after 18 months, after 24 months, after 30 months, after 36 months]
  • PROMIS-Anger Scale [Time frame: Baseline, after 4-6 weeks, after 6 months, after 12 months, after 18 months, after 24 months, after 30 months, after 36 months]
  • GHQ, Evaluation of distress [Time frame: Baseline, after 4-6 weeks, after 6 months, after 12 months, after 18 months, after 24 months, after 30 months, after 36 months]
  • Perceived Stress Scale [Time frame: Baseline, after 4-6 weeks, after 6 months, after 12 months, after 18 months, after 24 months, after 30 months, after 36 months]

Eligibility criteria

Inclusion criteria

  • Patients of legal capacity with an indication for device implantation (pacemaker, ICD, CRT, event recorder) who present at the Department of Cardiology and Angiology at the University Hospital Essen and consent to participate in the study will be included.

Exclusion criteria

  • none

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Germany · 1 center
  • Universitätsklinikum Essen, Klinik für Kardiologie und Angiologie — Essen

Publications

  • Golbidi S, Frisbee JC, Laher I. Chronic stress impacts the cardiovascular system: animal models and clinical outcomes. Am J Physiol Heart Circ Physiol. 2015 Jun 15;308(12):H1476-98. doi: 10.1152/ajpheart.00859.2014. Epub 2015 Apr 17. PMID 25888514
  • Pedersen SS, Wehberg S, Nielsen JC, Riahi S, Larroude C, Philbert BT, Johansen JB; DEFIB-WOMEN Investigators. Patients with an implantable cardioverter defibrillator at risk of poorer psychological health during 24 months of follow-up (results from the Danish national DEFIB-WOMEN study). Gen Hosp Psychiatry. 2023 Jan-Feb;80:54-61. doi: 10.1016/j.genhosppsych.2022.12.006. Epub 2023 Jan 3. PMID 36638700
  • Kim J, Park JK, Choi J, Kim SH, On YK, Shin MS, Choi N, Heo S. Changes in the Physical Function and Psychological Distress from Pre-Implant to 1, 6, and 12 Months Post-Implant in Patients Undergoing Implantable Cardioverter Defibrillator Therapy. J Clin Med. 2020 Jan 22;9(2):307. doi: 10.3390/jcm9020307. PMID 31979074
  • van Barreveld M, Verstraelen TE, van Dessel PFHM, Boersma LVA, Delnoy PPHM, Tuinenburg AE, Theuns DAMJ, van der Voort PH, Kimman GJ, Buskens E, Zwinderman AH, Wilde AAM, Dijkgraaf MGW; DO-IT Registry Investigators. Dutch Outcome in Implantable Cardioverter-Defibrillator Therapy: Implantable Cardioverter-Defibrillator-Related Complications in a Contemporary Primary Prevention Cohort. J Am Heart Ass PMID 33787324
  • Miller JL, Thylen I, Elayi SC, Etaee F, Fleming S, Czarapata MM, Lennie TA, Moser DK. Multi-morbidity burden, psychological distress, and quality of life in implantable cardioverter defibrillator recipients: Results from a nationwide study. J Psychosom Res. 2019 May;120:39-45. doi: 10.1016/j.jpsychores.2019.03.006. Epub 2019 Mar 5. PMID 30929706
  • Lampert R. Managing with pacemakers and implantable cardioverter defibrillators. Circulation. 2013 Oct 1;128(14):1576-85. doi: 10.1161/CIRCULATIONAHA.113.001555. No abstract available. PMID 24081953
  • Linde C. Quality-of-life in pacemaker and implantable cardioverter defibrillator recipients. Pacing Clin Electrophysiol. 2000 Jun;23(6):931-3. doi: 10.1111/j.1540-8159.2000.tb00876.x. No abstract available. PMID 10879374
  • Su SF, Wu MS. Arrhythmia Perception and Quality of Life in Bradyarrhythmia Patients Following Permanent Pacemaker Implantation. Clin Nurs Res. 2021 Feb;30(2):183-192. doi: 10.1177/1054773819880297. Epub 2019 Oct 16. PMID 31617405

Identifiers

NCT: NCT07343466 · 24-12310-BO

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗