Reflexology's Effect on Polycystic Ovary Syndrome (REPOS): A Pilot Study
试验速览
- 阶段
- 3 期
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- To identify the most appropriate primary outcome measure for the ensuing RCT
研究概览
简要总结
Polycystic Ovary Syndrome (PCOS) is very common, affecting approximately 5% of women of reproductive age, and impacts not only on quality of life, but also has long-term health consequences for many sufferers, such as increased risks of developing Type II diabetes, cardiovascular disease and cancer of the womb. The symptoms that may occur such as irregular periods; lots of body hair; thinning hair on scalp, obesity and infertility, can also lead to poor self-esteem. Whilst treatments can help fertility, other treatments to correct the other symptoms are less successful. Alternative methods to regulate periods would be helpful, especially ones which avoid the long-term use of steroids in patients who may already be overweight. Reflexology is poorly represented in scientific papers, with nothing published regarding reflexology and its effect upon PCOS. However patients who use reflexology report more regular periods, thicker hair on scalp and greater wellbeing. Therefore we aim to investigate the effect of reflexology on:
- The menstruation cycle (normal being every 21-35 days).
- Imbalances in hormone, insulin and blood sugar levels associated with PCOS.
- Other problems associated with PCOS such as thinning hair on scalp, excessive body hair, and obesity.
- Quality of life. Government and NHS agendas agree that if there's evidence of an effective complimentary therapy the NHS should provide it. Therefore the results may have an influence on the care pathways of patients with PCOS towards a more holistic, patient centred and empowered approach. It is also non invasive and liable to result in higher patient satisfaction regarding their treatment. This research may also inform policy makers so that complementary medicine provision is provided on a wider basis within the NHS, which at the moment is dictated by the individual Trust's budget allocation. However this research could save money overall as in America, the yearly cost of treating PCOS is $4.36 billion.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with PCOS
排除标准
- •use of complimentary therapies within 6/12 prior to recruitment
- •taken combined oral contraceptives, metformin, or cyclical progestogens within 3/12 prior to recruitment
结局指标
主要结局
To identify the most appropriate primary outcome measure for the ensuing RCT
时间窗: Week 30
次要结局
- Fasting Insulin and blood sugar levels(week 1 (baseline), week 10 (end of treatment) and week 30 (end of study))
- Quality of Life(week 1 (baseline), week 10 (end of treatment) and week 30 (end of study))
- Attainment of normal menstrual cycle length (i.e. 21-35 days)(1 (baseline), week 10 (end of treatment) and week 30 (end of study))
- Hormonal imbalances and irregular menses (commonly regarded at 6 cycles per annum or less)(1 (baseline), week 10 (end of treatment) and week 30 (end of study))
- weight, body mass index (BMI), hirsutism, thinning hair(week 1 (baseline), week 10 (end of treatment) and week 30 (end of study))