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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07371806
Acronym
MBSR-CADWOMEN
Enrollment
70
Registered
2026-01-28
Start date
2026-09-01
Completion date
2027-05-20
Last updated
2026-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease (CAD)

Keywords

Coronary artery disease, Mindfulness-based intervention, Quality of life

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALMindfulness-Based Intervention Program

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.

Sponsors

TC Erciyes University
Lead SponsorOTHER
Kayseri City Hospital
CollaboratorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

The study includes one intervention group and one control group.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Cardiac Quality of Life ScaleBaseline and at the end of the 8-week programThe 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

MeasureTime frameDescription
State-Trait Anxiety Inventory - Short Form (STAI-SF)Baseline and at the end of the 8-week programThe 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.

Countries

Turkey (Türkiye)

Contacts

CONTACTHatice Penekli, Master
peneklihatice@gmail.com+9

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 12, 2026