Effects of Combined Mind-Body Interventions in Patients With Coronary Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in Perceived Stress Scale (PSS) Score
研究概览
简要总结
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.
详细描述
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.
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
- Single (Outcomes Assessor)
盲法说明
No additional masking is applied. This is an open-label study.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with stable coronary artery disease
- •Aged between 18 and 65 years
- •Able to read and understand Turkish
- •Able to complete study questionnaires and assessments
- •Willing to provide written informed consent
排除标准
- •History of acute coronary syndrome within the last 3 months
- •Presence of a diagnosed severe psychiatric disorder
- •Cognitive impairment or communication difficulties that may interfere with study participation
- •Previous regular participation in mind-body interventions such as progressive muscle relaxation, guided imagery, meditation, or similar programs
研究组 & 干预措施
Intervention Group
Participants in this arm will receive an eight-session individualized mind-body intervention consisting of progressive muscle relaxation and guided imagery in addition to standard medical care. Sessions will be delivered twice weekly over four weeks in a clinical setting by trained researchers.
干预措施: Progressive Muscle Relaxation and Guided Imagery (Behavioral)
Control Group
Participants in this arm will receive standard medical care only without any additional psychological or behavioral intervention.
结局指标
主要结局
Change in Perceived Stress Scale (PSS) Score
时间窗: Baseline and 4 weeks
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.
次要结局
- Change in Hospital Anxiety and Depression Scale (HADS) Anxiety Score(Baseline and 4 weeks)
- Change in Hospital Anxiety and Depression Scale (HADS) Depression Score(Baseline and 4 weeks)
- Change in COPE Coping Strategies Scale Scores(Baseline and 4 weeks)
研究者
şeyda candeniz
Assistant Professor (Dr.)
Ankara University