None listed
Conditions
Brief summary
Polycystic Ovary Syndrome (PCOS) is the most common endocrine condition, with no studies in PCOS in young women. Adolescent PCOS is characterised by irregular menstrual cycles, acne, excess hair, obesity and psychological distress. Adolescents with PCOS have impaired quality of life (QOL) and increased stress. There are recent data suggesting that self-management strategies (mindfulness) have a role in improving QOL in women with PCOS however there are no studies in adolescents. Transcendental Meditation (TM) is a well-established and easy technique that is delivered in a standardised manner ensuring follow up. Meditation trials have shown beneficial effects on stress and blood pressure in adults. This project aims to evaluate the effect of TM on QOL and stress in adolescents with PCOS in a randomized trial over 8 weeks with assessments at 0 and 8 weeks. We expect the adolescents practicing TM will have a significant improvement in QOL and stress in comparison to adolescents not practicing TM.
Interventions
Transcendental Meditation for 15 minutes twice a day for 8 weeks.
Transcendental Meditation (TM) is a sitting meditation from ancient Vedic tradition originated from India. It is a simple, natural and effortless technique practiced while sitting with the eyes closed in adults for 20 minutes twice a day and in children for about 15 minutes twice a day. TM uses the sound value of a mantra (repetitive sound) to draw attention within the mind leading to a relaxed but mentally alert state. TM is a
Transcendental Meditation for 15 minutes twice a day for 8 weeks. Transcendental Meditation (TM) is a sitting meditation from ancient Vedic tradition originated from India. It is a simple, natural and effortless technique practiced while sitting with the eyes closed in adults for 20 minutes twice a day and in children for about 15 minutes twice a day. TM uses the sound value of a mantra (repetitive sound) to draw attention within the mind leading to a relaxed but mentally alert state. TM is a well-established and easy technique that is delivered in a standardised manner with careful attention to fidelity of the program by regular review of TM sessions.TM instruction will be delivered by certified and experienced TM female teacher from Transcendental Meditation Adelaide (190 Greenhill Rd, Parkside, SA 5063) and Transcendental Meditation Southern Region (21 Meadow Way, Hackham West, SA 5163). TM instructions will be given one on one. After initial instruction, the adolescent will establish twice daily practice of TM technique at their homes. There are 4 check-up sessions that will be delivered in groups of 2-4 on day 2, 3, 4 and in week 2, which will include a brief questionnaire where the adolescent answers the questions in relation to number of meditations done since previous session, experiences during meditation and any issues with the practice like how to time meditation, handling outside noise, etc. TM teacher reinforce fidelity of the program by encouraging practice review sessions after initial instruction and check-up sessions. There will be 3 practice review sessions in groups of 2-4 in week 3, 4 and 6 to do review their TM practice. Adherence will be monitored by using a dairy that the adolescent girls and/or their parents complete in the morning and afternoon in relation to their time spent on meditation.
Sponsors
Children, Youth and Women's Health Services
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
12 Years to 22 Years
Healthy volunteers
No
Inclusion criteria
1) Adolescent girls between 12 and 22 years who have been diagnosed with PCOS according to the recent international evidence based-guidelines diagnostic criteria for PCOS. Adolescent girls who are on metformin or other hormonal therapy (contraceptive pill, medroxyprogesterone or spironolactone) are eligible to participate in the study if they have been on a stable medical regimen for at least the previous 4 weeks. 2) Adolescent girls who are willing and able to participate in TM instruction and practice during the study. 3) Adolescent girls whose one of the parents is willing to be the involved in facilitating and keeping a diary card of TM practice or sitting activities in the control group.
Exclusion criteria
1) Adolescent girls with significant coexisting illness that may have a contributory effect on health related QOL such as diabetes (Type 1 or 2), gender dysphoria and/or severe anxiety or depression treated with medications. 2) Adolescent girls with a diagnosed psychiatrist condition such as schizophrenia or bipolar disorder as this is a contraindication for TM. 3) Adolescent girls with a high level of depression (DASS score higher than 20), anxiety (DASS score higher than 15) and/or stress (DASS score higher than 26) as they will require immediate treatment. 4) Adolescent girls who are regularly practicing TM or any other meditation/mind fullness program. 5) Adolescent girls with a substance use as it will interfere with TM practice. 6) Inability to speak English.
Outcome results
None listed