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临床试验/NCT07371806
NCT07371806招募中不适用

THE EFFECT OF A MINDFULNESS-BASED STRESS REDUCTION PROGRAM ON QUALITY OF LIFE , ANXIETY AND EMPOWERMENT LEVELS IN WOMEN WITH CORONARY ARTERY DISEASE

TC Erciyes University2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2026年9月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
70
试验地点
2
主要终点
Cardiac Quality of Life Scale

研究概览

简要总结

Coronary artery disease (CAD) is a common cardiovascular condition characterized by the narrowing or blockage of the coronary arteries that supply oxygen-rich blood to the heart muscle. CAD represents a significant cause of morbidity and mortality, particularly among individuals aged 40 and older, affecting millions of men and women worldwide. Patients with CAD experience not only physical symptoms but also psychological challenges, including stress and anxiety, which can negatively impact quality of life. In recent years, mindfulness-based interventions have emerged as scientifically supported approaches to help individuals with chronic diseases manage stress and enhance emotional regulation skills. While the existing literature includes studies evaluating the effects of mindfulness-based interventions in CAD and other cardiovascular conditions, most investigations address mixed patient populations and do not thoroughly examine sex-specific differences. Notably, women with CAD may experience symptoms and psychological effects differently than men. Therefore, there is a need for tailored, comprehensive intervention models that address the multidimensional needs of female patients, including stress management, anxiety reduction, and empowerment. This study aims to evaluate the effectiveness of mindfulness-based interventions in women with CAD, providing a targeted approach that addresses both clinical and psychosocial outcomes. The findings are expected to offer valuable insights into improving quality of life and enhancing coping strategies for women living with chronic cardiovascular disease.

详细描述

Coronary artery disease (CAD) is a prevalent cardiovascular condition that develops as a result of narrowing or blockage of the coronary arteries supplying blood to the heart, significantly affecting the cardiovascular system. CAD is recognized as a major cause of morbidity and mortality, particularly among individuals aged 40 and older. According to 2024 data from the British Heart Foundation (BHF), approximately 110 million men and 80 million women worldwide are affected by CAD, with the disease accounting for one in every six deaths globally. Similarly, data from the Turkish Statistical Institute, indicate that circulatory system diseases represent 36% of total deaths in Turkey, with 42.9% of these deaths attributable to ischemic heart diseases. CAD not only adversely impacts individual health but also imposes a significant burden on public health and healthcare systems. Its high prevalence, associated morbidity and mortality, long-term and costly treatment requirements, and the resulting decline in quality of life position CAD as a critical public health priority. Affecting millions of men and women worldwide, CAD leads not only to physical symptoms but also to psychological challenges that reduce quality of life. Stress, anxiety, and depressive symptoms are common psychosocial issues among patients with CAD and can complicate the management of chronic disease. In managing chronic illnesses, it is essential to enhance individuals' stress-coping skills, improve emotional regulation, and strengthen psychological resilience. In recent years, mindfulness-based interventions have emerged as scientifically supported approaches to achieve these objectives. Mindfulness and other awareness-based programs have been shown to help individuals cope with stress, manage anxiety, and improve psychological resilience. Existing literature includes studies evaluating the effects of mindfulness-based interventions in CAD and other cardiovascular conditions. However, most of these studies examine mixed patient populations and do not thoroughly investigate sex-specific differences. Notably, women with CAD experience symptoms, psychological stress, and quality-of-life challenges differently than men. Therefore, there is a clear need for tailored, targeted intervention models specifically designed for female patients with CAD.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Diagnosed with coronary artery disease (CAD) for at least 1 month.
  • Score of 14 or higher on the Short Form of the State-Trait Anxiety Inventory (STAI-SF) at baseline.
  • At least primary school education.
  • Age between 18 and 50 years.
  • Sexually active.
  • Having an active social network.

排除标准

  • Individuals with hearing or language impairments that would hinder communication.
  • Women who have entered menopause.
  • Women with psychiatric disorders.
  • Discontinuation Criteria:
  • Participants who choose to withdraw from the study.
  • Participants who miss two intervention sessions.
  • Participants with incomplete data on study forms.

研究组 & 干预措施

Standard Care in Women with Coronary Artery Disease

No Intervention

Participants in the control group will receive standard care, including routine medical follow-up and discharge education, without any structured intervention.

Mindfulness-Based Intervention Group

Experimental

Participants in the intervention group will take part in an 8-week mindfulness-based program designed to cultivate awareness related to anxiety, psychological resilience, and quality of life in women with coronary artery disease.

干预措施: Mindfulness-Based Intervention Program (Behavioral)

结局指标

主要结局

Cardiac Quality of Life Scale

时间窗: Baseline and at the end of the 8-week program

The Heart Quality of Life Scale (HeartQoL) is a reliable instrument developed to assess quality of life in individuals with ischemic heart disease (Oldridge, 2014). The scale consists of 14 items, with 10 assessing physical aspects and 4 assessing emotional aspects. Each item is scored from 0 to 3, with higher scores indicating better quality of life. It can be applied to individuals aged 18 and above. Turkish validity and reliability were established by Duğan (2018).

次要结局

  • State-Trait Anxiety Inventory - Short Form (STAI-SF)(Baseline and at the end of the 8-week program)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

HATİCE PENEKLİ

HATİCE PENEKLİ, PhD Candidate, Faculty of Nursing, Institute of Health Sciences, Erciyes University

TC Erciyes University

研究点 (2)

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