Reflexology's Effect on Polycystic Ovary Syndrome (PCOS) (REPOS)
Recruitment status was Not yet recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Reflexology's Effect on Polycystic Ovary Syndrome (REPOS): A Pilot Study|
- To identify the most appropriate primary outcome measure for the ensuing RCT [ Time Frame: Week 30 ] [ Designated as safety issue: No ]
- Attainment of normal menstrual cycle length (i.e. 21-35 days) [ Time Frame: 1 (baseline), week 10 (end of treatment) and week 30 (end of study) ] [ Designated as safety issue: No ]
- Hormonal imbalances and irregular menses (commonly regarded at 6 cycles per annum or less) [ Time Frame: 1 (baseline), week 10 (end of treatment) and week 30 (end of study) ] [ Designated as safety issue: No ]
- Weight, body mass index (BMI), hirsutism, thinning hair [ Time Frame: week 1 (baseline), week 10 (end of treatment) and week 30 (end of study) ] [ Designated as safety issue: No ]
- Fasting Insulin and blood sugar levels [ Time Frame: week 1 (baseline), week 10 (end of treatment) and week 30 (end of study) ] [ Designated as safety issue: No ]
- Quality of Life [ Time Frame: week 1 (baseline), week 10 (end of treatment) and week 30 (end of study) ] [ Designated as safety issue: No ]
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
10 weekly sessions of 45 minutes each
|No Intervention: 2|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00744510
|Contact: Dawn-Marie Walker, Phd||+44 (0)115 82 firstname.lastname@example.org|
|University of Nottingham Hospitals||Not yet recruiting|
|Nottingham, United Kingdom, NG7 2UH|
|Principal Investigator:||Dawn-Marie Walker, PhD||University of Nottingham|