Reflexology's Effect on Polycystic Ovary Syndrome: A Pilot Study (REPOS)
Primary Purpose
Polycystic Ovary Syndrome
Status
Unknown status
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
Reflexology
Sponsored by
About this trial
This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring Polycystic Ovary Syndrome, Reflexology, Complementary and Alternative Medicine, Endocrinopathy, Oligo, Amenorrhoea
Eligibility Criteria
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
Sites / Locations
- University of Nottingham Hospitals
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
1
2
Arm Description
Reflexology
No intervention
Outcomes
Primary Outcome Measures
To identify the most appropriate primary outcome measure for the ensuing RCT
Secondary Outcome Measures
Attainment of normal menstrual cycle length (i.e. 21-35 days)
Hormonal imbalances and irregular menses (commonly regarded at 6 cycles per annum or less)
weight, body mass index (BMI), hirsutism, thinning hair
Fasting Insulin and blood sugar levels
Quality of Life
Full Information
NCT ID
NCT00746148
First Posted
September 2, 2008
Last Updated
December 3, 2012
Sponsor
University of Nottingham
1. Study Identification
Unique Protocol Identification Number
NCT00746148
Brief Title
Reflexology's Effect on Polycystic Ovary Syndrome: A Pilot Study
Acronym
REPOS
Official Title
Reflexology's Effect on Polycystic Ovary Syndrome (REPOS): A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Unknown status
Study Start Date
December 2012 (undefined)
Primary Completion Date
November 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nottingham
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
Keywords
Polycystic Ovary Syndrome, Reflexology, Complementary and Alternative Medicine, Endocrinopathy, Oligo, Amenorrhoea
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Reflexology
Arm Title
2
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Other
Intervention Name(s)
Reflexology
Intervention Description
10 weekly sessions of 45 minutes each
Primary Outcome Measure Information:
Title
To identify the most appropriate primary outcome measure for the ensuing RCT
Time Frame
Week 30
Secondary Outcome Measure Information:
Title
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)
Title
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)
Title
weight, body mass index (BMI), hirsutism, thinning hair
Time Frame
week 1 (baseline), week 10 (end of treatment) and week 30 (end of study)
Title
Fasting Insulin and blood sugar levels
Time Frame
week 1 (baseline), week 10 (end of treatment) and week 30 (end of study)
Title
Quality of Life
Time Frame
week 1 (baseline), week 10 (end of treatment) and week 30 (end of study)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dawn-Marie Walker, Phd
Phone
+44 (0)115 82 30511
Email
dawn-marie.walker@nottingham.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dawn-Marie Walker, PhD
Organizational Affiliation
University of Nottingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nottingham Hospitals
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
12. IPD Sharing Statement
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Reflexology's Effect on Polycystic Ovary Syndrome: A Pilot Study
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