The Effect of Fascial Yoga on Perceived Stress, Cognitive Control, and Cognitive Flexibility in Menopausal Women
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Perceived Stress Level
研究概览
简要总结
Aim:
The aim of this study is to evaluate the effects of a structured fascial yoga-based behavioral intervention on perceived stress, cognitive control, and cognitive flexibility in menopausal women. The study aims to determine whether a non-pharmacological and non-invasive behavioral intervention can support psychological and cognitive functioning and reduce perceived stress in menopausal women.
Design:
This study is designed as a randomized controlled, pretest-posttest experimental study with a post-intervention follow-up assessment. Eligible participants will be randomly assigned to either the intervention group or the control group receiving usual care. Outcomes will be assessed at baseline, immediately after the intervention, and at follow-up to evaluate both the immediate and sustained effects of the intervention.
Method:
A total of 60 menopausal women aged 45-65 years will be recruited from the menopause outpatient clinic and randomly assigned to either the intervention group or the control group. The intervention group will participate in a 12-week online fascial yoga program consisting of two 60-minute sessions per week.
In this study, fascial yoga is defined as a fascia-focused, non-pharmacological, and non-invasive behavioral intervention that includes myofascial release techniques, breath regulation, body awareness, and basic yoga practices to support stress regulation and cognitive functioning. The program will include myofascial release techniques, basic yoga postures suitable for all physical fitness levels, and structured breathing exercises. All sessions will be conducted online in a group format, and no audio or video recordings will be taken.
The control group will continue to receive routine outpatient care during the study period. After completion of the follow-up assessments, the fascial yoga program will be offered to participants in the control group upon request.
Data will be collected at three time points: at baseline before the intervention, immediately after completion of the 12-week intervention, and at the follow-up assessment 8 weeks after the intervention. Perceived stress, cognitive control, and cognitive flexibility will be assessed using validated self-report questionnaires.
Hypotheses:
H1: Menopausal women participating in the fascial yoga intervention will show a significant reduction in perceived stress levels compared with the control group at post-intervention and follow-up assessments.
H2: Menopausal women participating in the fascial yoga intervention will show a significant improvement in cognitive control and cognitive flexibility compared with the control group at post-intervention and follow-up assessments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female participants aged 45-65 years
- •In the menopausal period, defined as at least 12 months since the last menstrual period
- •Able to read and understand Turkish and to complete self-report questionnaires
排除标准
- •Current or past diagnosis of a psychiatric disorder or ongoing psychiatric treatment
- •Regular use of antidepressant, anxiolytic, or corticosteroid medications
- •History of cancer or currently receiving active oncological treatment
- •Participation in fascial yoga, yoga, or similar yoga-based programs within the past 6 months
- •Any medical condition that may prevent safe participation in mild physical activity
研究组 & 干预措施
Usual Care
Fascial Yoga Intervention
干预措施: Fascial Yoga Program (Behavioral)
结局指标
主要结局
Perceived Stress Level
时间窗: Baseline, immediately post-intervention (12 weeks), and 8 weeks post-intervention follow-up
Change in perceived stress levels measured using the Perceived Stress Scale (PSS-14). The scale consists of 14 items rated on a 5-point Likert scale (0-4), with total scores ranging from 0 to 56. Higher scores indicate higher perceived stress levels.
Salivary Cortisol Level
时间窗: Baseline, immediately post-intervention (12 weeks), and 8 weeks post-intervention follow-up
Change in salivary cortisol levels measured from morning saliva samples collected under standardized conditions.
Cognitive Control and Flexibility
时间窗: Baseline, immediately post-intervention (12 weeks), and 8 weeks post-intervention follow-up
Change in cognitive control and cognitive flexibility levels measured using the Cognitive Control and Flexibility Questionnaire. The questionnaire consists of two subscales (cognitive control and cognitive flexibility), with items rated on a 7-point Likert scale. Higher scores indicate better cognitive control and greater cognitive flexibility.
次要结局
未报告次要终点
研究者
Ayşe Eminoğlu
Research Assistant
Marmara University