This randomized controlled study aims to evaluate the effects of a combined mind-body intervention consisting of progressive muscle relaxation and guided imagery on psychological outcomes in patients with stable coronary artery disease. A total of 40 participants will be randomly assigned to either an intervention group or a control group. The intervention group will receive eight individualized sessions over four weeks in addition to standard medical care, while the control group will continue with standard care only. Primary and secondary outcomes will be assessed using validated self-report instruments, including the Perceived Stress Scale (PSS), Hospital Anxiety and Depression Scale (HADS), and COPE Inventory, administered at baseline and after the intervention period. The main objective of the study is to determine whether structured mind-body techniques can reduce perceived stress, anxiety, and depressive symptoms and improve coping strategies in patients with coronary artery disease.
This study is a prospective, randomized controlled clinical trial designed to evaluate the effects of a structured mind-body intervention on psychological outcomes in patients with stable coronary artery disease. Eligible participants will be recruited from Ufuk University Department of Cardiology and randomly assigned to either an intervention group or a control group using a simple randomization method. The intervention group will receive eight individualized sessions of progressive muscle relaxation and guided imagery over a four-week period in addition to standard medical care. Each session will last approximately 45-60 minutes and will be conducted in a controlled clinical environment by trained researchers. The control group will continue receiving standard medical care without any additional psychological or behavioral intervention. Outcomes will be assessed at baseline and post-intervention using validated self-report instruments, including the Perceived Stress Scale (PSS), Hospital Anxiety and Depression Scale (HADS), and COPE Inventory. The primary outcome is change in perceived stress levels. Secondary outcomes include changes in anxiety, depression, and coping strategies. Data will be analyzed using repeated measures ANOVA to examine the interaction effects between group (intervention vs control) and time (baseline vs post-intervention). Effect sizes will be reported, and statistical significance will be set at p \< 0.05. The study does not involve any investigational drugs, biologics, or medical devices, and poses minimal risk to participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
A structured mind-body intervention consisting of progressive muscle relaxation and guided imagery techniques delivered in eight individualized sessions over four weeks.
Ufuk University Faculty of Medicine, Department of Cardiology
Ankara, Ankara, Turkey (Türkiye)
Change in Perceived Stress Scale (PSS) Score
The primary outcome is the change in perceived stress levels measured by the Perceived Stress Scale (PSS) between baseline and the end of the 4-week intervention period.Scores range from 0 to 16, with higher scores indicating greater perceived stress.
Time frame: Baseline and 4 weeks
Change in Hospital Anxiety and Depression Scale (HADS) Anxiety Score
Change in anxiety measured by the Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS). Scores range from 0 to 21, with higher scores indicating greater anxiety symptoms. Outcome will be assessed at baseline and 4 weeks.
Time frame: Baseline and 4 weeks
Change in Hospital Anxiety and Depression Scale (HADS) Depression Score
Change in depression measured by the Hospital Anxiety and Depression Scale - Depression Subscale (HADS). Scores range from 0 to 21, with higher scores indicating greater depressive symptoms. Outcome will be assessed at baseline and 4 weeks.
Time frame: Baseline and 4 weeks
Change in COPE Coping Strategies Scale Scores
Change in coping strategies measured by the COPE Inventory. The instrument contains 15 coping subscales, each scored from 4 to 16, with higher scores indicating greater use of the respective coping strategy. Outcomes will be assessed at baseline and 4 weeks.
Time frame: Baseline and 4 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.