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Peer-reviewedCC BY-NC 4.0BMJ Open

Trajectory changes in psychosocial adaptation levels of patients after implantation of cardiac implantable electronic devices and development of the intervention programme: a mixed-methods research protocol

  • Meirong Chen1
  • Minting Lu1
  • Hui Huang1
  • Xiuzhen Huang1
  • Jieshan Xu1
  • Airong Li1
  • Xiaoyan Liao1
  • Yuyan He1
  1. 1Cardiovascular medicine, The First People's Hospital of Foshan, Foshan, China
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Abstract

Introduction: The implantation of cardiac implantable electronic devices (CIEDs) has become an important treatment for various types of arrhythmias and severe heart failure, effectively improving patient prognosis and increasing survival rates. However, patients after CIED implantation need to go through a process of coexisting with and adapting to the internal electronic device. This may result in limitations in daily activities, discomfort and lifestyle changes, which can easily lead to negative emotions and psychosocial maladjustment in the patients, seriously affecting their physical and mental rehabilitation and prognosis. This study aims to explore the trajectory of psychosocial adaptation and its influencing factors among patients after CIED implantation and to gain an in-depth understanding of their process of physical and psychological adjustment. Drawing on the research findings and existing literature, this study will develop an intervention programme to improve psychosocial adaptation among patients after CIED implantation, thereby providing a theoretical and practical basis for future clinical interventions in this population.

Methods and analysis: This study focuses on patients who have undergone CIED implantation. A mixed-methods approach will be adopted, combining a cross-sectional survey, a prospective longitudinal quantitative design and a qualitative design. (1) Quantitative study: The Basic Information Questionnaire , Chinese version of Self-report Psychosocial Adjustment to Illness Scale , Chinese version of Medical Coping Modes Questionnaire , Chinese version of Acceptance of Illness Scale , Chinese version of Multidimensional Scale of Perceived Social Support, Self-efficacy for Managing Chronic Disease and Health Literacy Management Scale will be administered to patients after CIED implantation to explore the latent categories, associated factors and longitudinal trajectories of psychosocial adaptation. Statistical analysis will be conducted using Statistical analysis was performed using IBM SPSS Statistics version 26 (SPSS 26) and Mplus software. (2) Qualitative study: Based on descriptive phenomenology, semi-structured interviews will be conducted with patients after CIED implantation to gain an in-depth understanding of their life experiences of psychosocial adaptation, as well as their process of physical and psychological adjustment. The data will be analysed using the Colaizzi 7-step method of phenomenological analysis, supported by NVivo software for data organisation and coding. (3) Development of the intervention programme: Based on the literature review and theoretical framework, and integrating findings from both the quantitative and qualitative phases, an intervention programme for improving the psychosocial adaptation among patients after CIED implantation will be initially developed. The Delphi method will be used to evaluate and revise the initially developed intervention programme. A pilot test will subsequently be conducted to further refine the programme.

Ethics and dissemination: This research plan has been approved by the Ethics Committee of the First People’s Hospital of Foshan (Approval Number: LSY-2025-019). Data collection is authorised by the Ethics Committee of the First People’s Hospital of Foshan. The results of this study will be published in relevant peer-reviewed journals.

Trial registration number: ChiCTR2600124496.

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Cite

BibTeXRIS
BibTeX
@article{chen2026trajectory,
  title = {{Trajectory changes in psychosocial adaptation levels of patients after implantation of cardiac implantable electronic devices and development of the intervention programme: a mixed-methods research protocol}},
  author = {Meirong Chen and Minting Lu and Hui Huang and Xiuzhen Huang and Jieshan Xu and Airong Li and Xiaoyan Liao and Yuyan He},
  journal = {BMJ Open},
  year = {2026},
  month = oct,
  doi = {10.1136/bmjopen-2026-124197},
  url = {https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-124197},
  note = {CC BY-NC 4.0},
}
RIS
TY  - JOUR
TI  - Trajectory changes in psychosocial adaptation levels of patients after implantation of cardiac implantable electronic devices and development of the intervention programme: a mixed-methods research protocol
AU  - Meirong Chen
AU  - Minting Lu
AU  - Hui Huang
AU  - Xiuzhen Huang
AU  - Jieshan Xu
AU  - Airong Li
AU  - Xiaoyan Liao
AU  - Yuyan He
PY  - 2026
DA  - 2026/10/07
JO  - BMJ Open
DO  - 10.1136/bmjopen-2026-124197
UR  - https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-124197
AB  - Introduction: The implantation of cardiac implantable electronic devices (CIEDs) has become an important treatment for various types of arrhythmias and severe heart failure, effectively improving patient prognosis and increasing survival rates. However, patients after CIED implantation need to go through a process of coexisting with and adapting to the internal electronic device. This may result in limitations in daily activities, discomfort and lifestyle changes, which can easily lead to negative emotions and psychosocial maladjustment in the patients, seriously affecting their physical and mental rehabilitation and prognosis. This study aims to explore the trajectory of psychosocial adaptation and its influencing factors among patients after CIED implantation and to gain an in-depth understanding of their process of physical and psychological adjustment. Drawing on the research findings and existing literature, this study will develop an intervention programme to improve psychosocial adaptation among patients after CIED implantation, thereby providing a theoretical and practical basis for future clinical interventions in this population.  Methods and analysis: This study focuses on patients who have undergone CIED implantation. A mixed-methods approach will be adopted, combining a cross-sectional survey, a prospective longitudinal quantitative design and a qualitative design. (1) Quantitative study: The Basic Information Questionnaire , Chinese version of Self-report Psychosocial Adjustment to Illness Scale , Chinese version of Medical Coping Modes Questionnaire , Chinese version of Acceptance of Illness Scale , Chinese version of Multidimensional Scale of Perceived Social Support, Self-efficacy for Managing Chronic Disease and Health Literacy Management Scale will be administered to patients after CIED implantation to explore the latent categories, associated factors and longitudinal trajectories of psychosocial adaptation. Statistical analysis will be conducted using Statistical analysis was performed using IBM SPSS Statistics version 26 (SPSS 26) and Mplus software. (2) Qualitative study: Based on descriptive phenomenology, semi-structured interviews will be conducted with patients after CIED implantation to gain an in-depth understanding of their life experiences of psychosocial adaptation, as well as their process of physical and psychological adjustment. The data will be analysed using the Colaizzi 7-step method of phenomenological analysis, supported by NVivo software for data organisation and coding. (3) Development of the intervention programme: Based on the literature review and theoretical framework, and integrating findings from both the quantitative and qualitative phases, an intervention programme for improving the psychosocial adaptation among patients after CIED implantation will be initially developed. The Delphi method will be used to evaluate and revise the initially developed intervention programme. A pilot test will subsequently be conducted to further refine the programme.  Ethics and dissemination: This research plan has been approved by the Ethics Committee of the First People’s Hospital of Foshan (Approval Number: LSY-2025-019). Data collection is authorised by the Ethics Committee of the First People’s Hospital of Foshan. The results of this study will be published in relevant peer-reviewed journals.  Trial registration number: ChiCTR2600124496.
SN  - 2044-6055
SN  - 2044-6055
ER  -