Reflexology's Effect on Polycystic Ovary Syndrome (PCOS) (REPOS)

This study is not yet open for participant recruitment.
Verified December 2012 by University of Nottingham
Sponsor:
Information provided by (Responsible Party):
University of Nottingham
ClinicalTrials.gov Identifier:
NCT00744510
First received: August 29, 2008
Last updated: December 3, 2012
Last verified: December 2012

August 29, 2008
December 3, 2012
December 2012
March 2013   (final data collection date for primary outcome measure)
To identify the most appropriate primary outcome measure for the ensuing RCT [ Time Frame: Week 30 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00744510 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Reflexology's Effect on Polycystic Ovary Syndrome (PCOS)
Reflexology's Effect on Polycystic Ovary Syndrome (REPOS): A Pilot Study

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:

  1. The menstruation cycle (normal being every 21-35 days).
  2. Imbalances in hormone, insulin and blood sugar levels associated with PCOS.
  3. Other problems associated with PCOS such as thinning hair on scalp, excessive body hair, and obesity.
  4. 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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Polycystic Ovary Syndrome
Other: Reflexology
10 weekly sessions of 45 minutes each
  • Experimental: 1
    Reflexology
    Intervention: Other: Reflexology
  • No Intervention: 2
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
140
December 2013
March 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Women with PCOS

Exclusion Criteria:

  • Use of complimentary therapies within 6/12 prior to recruitment
  • BMI >35
  • Taken combined oral contraceptives, metformin, or cyclical progestogens within 3/12 prior to recruitment
Female
20 Years to 38 Years
No
Contact: Dawn-Marie Walker, Phd +44 (0)115 82 30511 dawn-marie.walker@nottingham.ac.uk
United Kingdom
 
NCT00744510
dmw2
No
University of Nottingham
University of Nottingham
Not Provided
Principal Investigator: Dawn-Marie Walker, PhD University of Nottingham
University of Nottingham
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP