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

NCT07371806 | Not Yet Recruiting

• 1 other identifier: ErciyesU-SBF-HP-01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease (CAD)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Cardiac Quality of Life Scale

  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).

  Baseline and at the end of the 8-week program

Secondary Outcomes (1)

• State-Trait Anxiety Inventory - Short Form (STAI-SF)

  Baseline and at the end of the 8-week program

Other Outcomes (1)

• Coronary Artery Disease Empowerment Scale

  Baseline and at the end of the 8-week program

Study Arms (2)

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.

Behavioral: Mindfulness-Based Intervention Program

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.

Interventions

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.

Mindfulness-Based Intervention Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Only female patients with coronary artery disease are eligible to participate in the study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• TC Erciyes University: lead
• Kayseri City Hospital: collaborator

Study Sites (1)

Kayseri Şehir Hastanesi

Kayseri, Türki̇ye, 38000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Hatice Penekli, Master

CONTACT

+9; peneklihatice@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: HATİCE PENEKLİ, PhD Candidate, Faculty of Nursing, Institute of Health Sciences, Erciyes University

Model Details: The study includes one intervention group and one control group.

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: January 28, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): October 15, 2026
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)