Reflexology's Effect on Polycystic Ovary Syndrome (PCOS)

NCT ID: NCT00744510

Last Updated: 2012-12-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2013-12-31

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:

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.

Conditions

Polycystic Ovary Syndrome

Keywords

Polycystic Ovary Syndrome; Reflexology; Complementary and Alternative Medicine; Endocrinopathy; Oligo; Amenorrhoea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Reflexology

Group Type: EXPERIMENTAL

Reflexology

Intervention Type: OTHER

10 weekly sessions of 45 minutes each

2

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Reflexology

10 weekly sessions of 45 minutes each

Intervention Type: OTHER

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 38 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Nottingham

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dawn-Marie Walker, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nottingham

Locations

University of Nottingham Hospitals

Nottingham, Nottingham, United Kingdom

Countries

United Kingdom

Central Contacts

Dawn-Marie Walker, Phd

Role: CONTACT

Phone: +44 (0)115 82 30511

Email: dawn-marie.walker@nottingham.ac.uk

Other Identifiers

dmw2

Identifier Type: -

Identifier Source: org_study_id