Reflexology's Effect on Polycystic Ovary Syndrome (PCOS) (REPOS)
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|ClinicalTrials.gov Identifier: NCT00744510|
Recruitment Status : Unknown
Verified December 2012 by University of Nottingham.
Recruitment status was: Not yet recruiting
First Posted : September 1, 2008
Last Update Posted : December 4, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Polycystic Ovary Syndrome||Other: Reflexology||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Reflexology's Effect on Polycystic Ovary Syndrome (REPOS): A Pilot Study|
|Study Start Date :||December 2012|
|Estimated Primary Completion Date :||March 2013|
|Estimated Study Completion Date :||December 2013|
10 weekly sessions of 45 minutes each
|No Intervention: 2|
- To identify the most appropriate primary outcome measure for the ensuing RCT [ Time Frame: Week 30 ]
- 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) ]
- 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) ]
- Weight, body mass index (BMI), hirsutism, thinning hair [ Time Frame: week 1 (baseline), week 10 (end of treatment) and week 30 (end of study) ]
- Fasting Insulin and blood sugar levels [ Time Frame: week 1 (baseline), week 10 (end of treatment) and week 30 (end of study) ]
- Quality of Life [ Time Frame: week 1 (baseline), week 10 (end of treatment) and week 30 (end of study) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|