The Effect of Yoga on Quality of Life, Sleep Quality, and Spiritual Well-Being in Women Who Undergo Surgical Menopause Following Gynecological Cancer Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Change in Quality of Life with yoga
研究概览
简要总结
This randomized controlled trial investigates the effects of yoga on quality of life, sleep quality, and spiritual well-being in women who have entered surgical menopause after gynecological cancer surgery. Yoga is expected to be a supportive intervention for symptom management and to improve overall well-being in this patient population.
详细描述
Surgical menopause after gynecological cancer surgery is associated with sudden and severe symptoms that may reduce quality of life, disturb sleep, and affect overall well-being. Supportive non-pharmacological approaches such as yoga may help manage these challenges.
This randomized controlled trial will investigate the effects of an 8-week yoga program on quality of life, sleep quality, and spiritual well-being in women who have entered surgical menopause. Forty-six participants will be randomly assigned to either a yoga intervention group or a control group. The intervention group will attend two yoga sessions per week (one online, one face-to-face) in small groups or individually with a certified instructor, while the control group will receive usual care and be offered yoga after the study.
Assessments will be conducted at baseline, post-intervention (8 weeks), and 3-month follow-up using standardized questionnaires. It is expected that yoga will support symptom management and improve overall well-being in this patient population.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age between 18-65 years Diagnosis of primary gynecological cancer (ovarian, endometrial, cervical, vaginal, or vulvar) (Stage I-III) Ability to read, understand, and speak Turkish Completion of all adjuvant treatments (surgery, chemotherapy, and/or radiotherapy) at least 6 months prior Access to the internet Having a computer/tablet/phone with a camera Willingness and ability to attend at least 80% of the yoga sessions Voluntary participation in the study
排除标准
- •Any condition that prevents communication Cognitive, sensory, or physical impairment that prevents yoga practice Diagnosis of metastatic gynecological cancer Regular yoga practice within the last 6 months (at least once a week for 8 consecutive weeks)
研究组 & 干预措施
Study Group
Individuals who perform yoga
干预措施: Yoga (Behavioral)
Control Group
Controls
结局指标
主要结局
Change in Quality of Life with yoga
时间窗: Baseline, 2 months (end of intervention), and 5 months (3-month follow-up)
Change in WHOQOL-BREF total score. Scores range 0-100; higher scores indicate better quality of life.
次要结局
- Change in Sleep Quality(Baseline, 2 months (end of intervention), and 5 months (3-month follow-up))
- Change in Menopausal Symptoms(Baseline, 2 months (end of intervention), and 5 months (3-month follow-up))
- Change in Spiritual Well-Being(Baseline, 2 months (end of intervention), and 5 months (3-month follow-up))
研究者
Selcan Zeynep Ergöz Aksoy
RN. MSc.
Dokuz Eylul University