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NCT Number: NCT07371806

EFFETCS OF MİNDFULNESS-BASED STRESS REDUCTION İN WOMEN WİTH CORONARY ARTERY DİSEASE

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kayseri Şehir Hastanesi

Kayseri, Türki̇ye, 38000, Turkey (Türkiye)

Location contact

Hatice Penekli- Master

CONTACT

[email protected]

+9

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Mindfulness-Based Intervention Program

Behavioral

This intervention is an 8-week structured mindfulness-based program designed to cultivate awareness related to anxiety, psychological resilience, and quality of life in women with coronary artery disease. The program includes meditation, breathing, and mindfulness exercises, distinguishing it from the standard care received by the control group.

Primary outcomes

  1. Cardiac Quality of Life Scale

    Time frame: 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).

Secondary outcomes

  1. State-Trait Anxiety Inventory - Short Form (STAI-SF)

    Time frame: Baseline and at the end of the 8-week program

    The State-Trait Anxiety Inventory - Short Form (STAI-SF) is a reliable tool developed to assess general anxiety levels in individuals (Spielberger et al., 1970). Its Turkish adaptation was made by Öner and Le Compte (1985). The short form was later developed by Zsido et al. (2020) and consists of 5 items using a 4-point Likert scale. Scores of 14 or higher indicate clinically significant anxiety. The internal consistency ranges between 0.83-0.86, and its Turkish validity and reliability have been established (Döner et al., 2021). The scale can be applied to individuals aged 18 and above.

Other outcomes

  1. Coronary Artery Disease Empowerment Scale

    Time frame: Baseline and at the end of the 8-week program

    The Coronary Artery Disease Empowerment Scale (CADES) is a reliable tool developed to assess patients' ability to manage their health and their empowerment levels (Kim et al., 2021). The scale consists of 24 items across three subscales: Autonomy (12 items), Emotional Self-Control (6 items), and Perceived Personal Competence in Disease Management (6 items). Items are rated on a 5-point Likert scale; higher scores indicate greater empowerment. Turkish validity and reliability were established by Çetin and Arslan (2023). The scale can be applied to individuals aged 18 and above.

Study contacts

Contact information is provided by the study sponsor or research team.

Hatice Penekli, Master

CONTACT

[email protected]

+9

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Collaborators

  • Kayseri City Hospital

Registry information

Official study title

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

Acronym: MBSR-CADWOMEN

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 28, 2026
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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