Accepted for/Published in: JMIR Research Protocols
Date Submitted: May 1, 2019
Date Accepted: Aug 21, 2019
A protocol of a randomised controlled trial to assess whether meditation improve quality of life in adolescents with polycystic ovary syndrome.
ABSTRACT
Background:
Polycystic Ovary Syndrome (PCOS) is a common endocrine condition characterised by irregular periods, hirsutism, acne and/or hyperandrogenemia. Adolescents with PCOS have impaired quality of life (QOL) and increased psychological distress. Transcendental Meditation® (TM) is a well-established self-management strategy that has been used to improve stress and well-being. Meta-analysis of TM trials has shown beneficial effects on stress and blood pressure in adults. There are recent data suggesting that another self-management strategy called mindfulness stress management program has a role in improving QOL in women with PCOS, but there are no studies in adolescents.
Objective:
The aim of this study is to evaluate the effect of TM on QOL and psychological distress in adolescent girls with PCOS.
Methods:
This study is a randomised controlled trial over 8 weeks that will be conducted at the Women’s and Children’s Hospital in Adelaide, South Australia to determine the effect of TM on QOL and psychological distress in adolescent girls (aged 12-20 years) with PCOS. Forty girls will be randomised into either the TM (n=20) or control group (n=20). TM group will be asked to practise TM in a comfortable sitting position with the eyes closed 15 minutes twice daily for 8 weeks. The control group will be asked to sit quietly for 15 minutes twice daily for 8 weeks. The primary outcomes are the QOL and psychological distress. Secondary outcomes are blood pressure and salivary cortisol levels.
Results:
Recruitment of study participants began in March 2019 and is expected to be completed by June 2020. It is expected that the adolescent girls with PCOS practicing TM over 8 weeks will have a significant improvement in QOL and psychological distress compared to adolescents in the control group. Also it is expected that adolescent girls in the TM group will have lower salivary cortisol levels and lower blood pressure.
Conclusions:
This study will be first to evaluate the effect of TM on QOL in adolescent girls with PCOS. The study will provide important information on a potential self-management strategy to improve QOL and well-being in adolescent girls with PCOS. Clinical Trial: ACTRN1261900019010. http://www.anzctr.org.au/ Registered 11 February 2019.
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