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Trial registered on ANZCTR


Registration number
ACTRN12619000190101
Ethics application status
Approved
Date submitted
14/01/2019
Date registered
11/02/2019
Date last updated
8/04/2019
Date data sharing statement initially provided
11/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Does meditation improve quality of life and coping in adolescents with polycystic ovary syndrome?
Scientific title
Does meditation improve quality of life and coping in adolescents with polycystic ovary syndrome? A randomised controlled trial.
Secondary ID [1] 296976 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Polycystic Ovary Syndrome 310940 0
Condition category
Condition code
Metabolic and Endocrine 309606 309606 0 0
Other endocrine disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 313252 0
Treatment: Other
Comparator / control treatment
Sitting quietly for 15 minutes twice a day for 8 weeks (read a book, write or listen to some music).

Adolescents in the control group will receive one healthy lifestyle education session on day 1 and seven email or phone contact with healthy lifestyle information on day 2, 3, 4, and week 2, 3, 4 and 6 similarly as per the intervention group. Adherence will be monitored by using a diary that the adolescent girls and/or their parents complete in the morning and afternoon in relation their time spent on sitting quietly.
Control group
Active

Outcomes
Primary outcome [1] 318568 0
Quality of life (QOL) assessed using Paediatric QOL questionnaire
Timepoint [1] 318568 0
Completed at baseline (pre-treatment) and at 8 weeks (post-treatment)
Primary outcome [2] 318760 0
Health related quality of life (QOL) in PCOS participants assessed using Specific QOL questionnaire for PCOS (PCOSQ).
Timepoint [2] 318760 0
Completed at baseline (pre-treatment) and at 8 weeks (post-treatment)
Primary outcome [3] 318761 0
Depression, anxiety and stress assessed using Depression Anxiety Stress Scales questionnaire
Timepoint [3] 318761 0
Completed at baseline (pre-treatment) and at 8 weeks (post-treatment)
Secondary outcome [1] 365397 0
Cortisol level. Salivary cortisol will be collected with salivary cortisol sampling kits (Salivettes) and specific instructions will be provided for proper collection. Three salivary cortisol samples (immediate after awakening in the morning, 30 minutes later and before going to bed). The 3 samples will be collected the day before baseline assessment and the day before the 8 weeks assessment. Salivary cortisol concentrations will be measured by IDS-iSYS Salivary Cortisol assay (Abacus ALS Pty Ltd).
Timepoint [1] 365397 0
At baseline (pre-treatment) and at 8 weeks (post-treatment)
Secondary outcome [2] 365750 0
Blood pressure will be measured with appropriate-size cuff on the left arm and the mean of 3 consecutive measurements will be recorded using an automatic sphygmomanometer.
Timepoint [2] 365750 0
At baseline (pre-treatment) and at 8 weeks (post-treatment)

Eligibility
Key inclusion criteria
1) Adolescent girls between 12 and 20 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.

Minimum age
12 Years
Maximum age
20 Years
Gender
Females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes will be used to conceal allocation. The person who determined if a subject was eligible for inclusion in the trial will be unaware, when this decision is made, to which group the subject would be allocated.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Adolescent girls will be randomised by computer generated random digit sampling to TM practice or control group.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The anticipated SD of the key outcome is 21.5 as per previous study. A change in the key outcome of 21.2 will be meaningful as this improvement will be similar to values obtained in adolescents. Power for this study was calculated as 80%. Two-tailed p-value < 0.05. Sample size was calculated based on a change in quality of life of 21.2 (SD 21.5) from baseline to 8 weeks in the TM group compared to no change in the control group. Forty adolescents will provide 80 % power at a 5% significance level accounting for a 10% drop out.

Statistical analysis will be done following the principle of intention to treat. A Linear Mixed Effects Model will be used to compare the subject change in each outcome (QOL, PCOSQ, depression, anxiety and stress questionnaires, salivary cortisol and blood pressure) between treatment categories (TM and control group) over the study period.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 12821 0
Womens and Childrens Hospital - North Adelaide
Recruitment postcode(s) [1] 25291 0
5006 - North Adelaide

Funding & Sponsors
Funding source category [1] 301549 0
Charities/Societies/Foundations
Name [1] 301549 0
Women's and Children's Hospital foundation research project grant
Address [1] 301549 0
Women's and Children's Hospital, 72 King William Rd, North Adelaide SA 5006
Country [1] 301549 0
Australia
Primary sponsor type
Government body
Name
Children, Youth and Women's Health Services
Address
72 King William Rd, North Adelaide SA 5006
Country
Australia
Secondary sponsor category [1] 301247 0
None
Name [1] 301247 0
Address [1] 301247 0
Country [1] 301247 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302283 0
Women's and Children's Health network Human Research Ethics Committee
Ethics committee address [1] 302283 0
72 King William Road
North Adelaide SA 5006

Ethics committee country [1] 302283 0
Australia
Date submitted for ethics approval [1] 302283 0
21/11/2018
Approval date [1] 302283 0
05/12/2018
Ethics approval number [1] 302283 0
HREC/18/WCHN/168

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89686 0
Dr Alexia Sophie Pena
Address 89686 0
C/O Endocrine Department
Women's and Children's Hospital,
72 King William Road,
North Adelaide
SA 5006
Country 89686 0
Australia
Phone 89686 0
+61 8 81616402
Fax 89686 0
+61 8 81617759
Email 89686 0
alexia.pena@adelaide.edu.au
Contact person for public queries
Name 89687 0
Dr Alexia Sophie Pena
Address 89687 0
C/O Endocrine Department
Women's and Children's Hospital,
72 King William Road,
North Adelaide
SA 5006
Country 89687 0
Australia
Phone 89687 0
+61 8 81616402
Fax 89687 0
+61 8 81617759
Email 89687 0
alexia.pena@adelaide.edu.au
Contact person for scientific queries
Name 89688 0
Dr Alexia Sophie Pena
Address 89688 0
C/O Endocrine Department
Women's and Children's Hospital,
72 King William Road,
North Adelaide
SA 5006
Country 89688 0
Australia
Phone 89688 0
+61 8 81616402
Fax 89688 0
+61 8 81617759
Email 89688 0
alexia.pena@adelaide.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data may be shared at a later date if permission is granted from the Human Research Ethics Committee
What supporting documents are/will be available?
No other documents available
Summary results
No Results