The Effect of Acupressure on Menopausal Symptoms: A Randomized, Sham Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 2
- 主要终点
- Menopause Rating Scale (MRS)
研究概览
简要总结
This is a prospective, randomized, placebo-controlled and single-blind study planned to determine the effect of acupressure application on menopausal symptoms.
The hypothesis of the study is that acupressure reduces women's menopausal symptoms.
详细描述
Menopause is a physiological process during which most women have difficulties and face many problems. Acupressure can be taught and used safely as an effective method to manage the symptoms that women experience during menopause.
This study aims to determine the effect of acupressure on menopausal symptoms. The study has a prospective, randomized, sham-controlled, single-blind design. The research was conducted with 81 women (acupressure n=40, sham acupressure n=41) attending the "Menopause School" in a public hospital in Türkiye between July 05, 2021 and August 02, 2021. Both groups received acupressure application thrice a week for four weeks, 12 sessions in total. The data was obtained using a personal information form and a Menopause Rating Scale.
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
- Single (Participant)
盲法说明
81 people who attended the menopause school and met the inclusion criteria were selected by simple random sampling. Each of the women was allowed to draw from the numbers in the bell, and those who drew odd numbers were assigned to the placebo group, and those who drew even numbers were assigned to the acupressure group. Acupressure pressure point was applied to all women included in the study. Participants were blinded because they did not know whether the women were given acupressure or placebo acupressure. Researchers could not be blinded because they were also practitioners (Melek Yeşil Bayülgen and Fatma Hikmet Yeşil). When the research was completed, the data were analyzed by a statistician who did not know the groups and the findings were reported
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Able to speak and understand Turkish
- •No psychiatric illness
- •Natural menopause
- •Not on hormone replacement therapy
- •Women who volunteered to participate in the study and did not receive any integrated therapy were included.
排除标准
- •Those who have undergone menopause with the surgical method
- •For lower extremity vascular disease, fracture, sprain or injury, diabetes, cardiovascular disease, thyroid disease, etc. with a diagnosis
- •Women who received any integrative therapy were not included in the study.
结局指标
主要结局
Menopause Rating Scale (MRS)
时间窗: Change from before implementation, 0th week and 4th week of practice
Menopause symptom rating scale was used to evaluate menopausal symptoms. The Turkish reliability and validity study was conducted by Can (2005). The scale consists of 11 items and 3 sub-dimensions. For each item, there are "0=None", "1=Mild", "2=Moderate", "3=Severe" and "4=Very Severe" options. Sub-dimensions of the scale; somatic complaints (items 1,2,3 and 11), psychological complaints (items 4,5,6 and 7), and urogenital complaints (items 8,9 and 10). The total score of the scale ranges from 0 to 44. The somatic complaints sub-dimension is scored between 0-16, the psychological complaints sub-dimension 0-16, and the urogenital complaints sub-dimension 0-12. An increase in the total score obtained from the scale indicates that the severity of the complaints increases and the quality of life is negatively affected.
次要结局
未报告次要终点
研究者
Melek Yesil Bayulgen
Lecturer (Principal Investigator)
Mersin University