Please note that the ANZCTR website will be unavailable from 6pm until 6.30pm (AEST) on Monday 22nd July for website maintenance. Please be sure to log out of the system in order to avoid any loss of data. Thank you and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12619000031167
Ethics application status
Approved
Date submitted
8/01/2019
Date registered
11/01/2019
Date last updated
11/01/2019
Date data sharing statement initially provided
11/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Development and trial of a school-based “Whole Person ovulatory-menstrual (OM) health literacy program” for 13-16 year old (Year 9-10) females in Perth Western Australia.
Scientific title
A formative intervention research study to develop and trial a school-based “Whole Person ovulatory-menstrual (OM) health literacy program” for 13-16 year old (Year 9-10) females in Perth Western Australia.
Secondary ID [1] 296994 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Menstrual cycle 310960 0
Dysmenorrhoea 310961 0
Premenstrual syndrome 310962 0
Abnormal uterine bleeding 310963 0
Polycystic ovarian sydrome 310964 0
Health literacy 311003 0
Condition category
Condition code
Public Health 309623 309623 0 0
Health promotion/education
Reproductive Health and Childbirth 309624 309624 0 0
Menstruation and menopause
Reproductive Health and Childbirth 309625 309625 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Name: Ovulatory menstrual health literacy educational intervention

Materials: These are currently being developed with completion envisaged by 2019. Development is based on a systematic literature review, consultation with a panel of reproductive health and educational experts and focus groups of students, teachers and school health care professionals. These are the materials currently being developed:
- Student workbook of cycle charts and guided reflections
- Teacher workbook guide and support plan
- Demonstration aides: vulva puppets, clay model wombs, menstrual cycle scarves, menstrual pads and tampons. Faux cervical mucus (such as raw egg white, paste glue, water) will be used in a hands-on demonstration of the different types of cervical mucus indicating the fertile (ovulatory) and infertile phases of the menstrual cycle. Students will be invited to touch the faux cervical mucus and note its sensation, colour and texture.

Staffing: Secondary School facilitator of reproductive health with 15 years' experience

Delivery mode: Face to face delivery in a group (class) based setting

Frequency:
- Program delivery will be once a week for one hour over 9 weeks. Topics covered and weekly session details:
1. "Who am I?" in a Whole Person context and consideration of reproductive / endocrinological function (lecture and group work using vulva puppets and menstrual cycle scarves)
2. Making and recording fertility observations on a chart (lecture, group work using vulva puppets, faux cervical mucus, menstrual cycle scarves and individual work on starting the first chart in student workbook)
3. Abnormal uterine bleeding / polycystic ovarian syndrome (lecture, group work with menstrual cycle scarves and menstrual pads / tampons, individual work on reflection exercises or verifying charts)
4. Sleep hygiene (lecture, group discussion on enabler and inhibitors of a good night's sleep)
5. Dysmenorrhoea / endometriosis (lecture, group work on recording pain experience on cycle charts, individual work on reflection exercises or verifying charts)
6. Nutrition and exercise (lecture, group discussion on enablers and inhibitors of healthy living)
7. Premenstrual syndrome (lecture, group work on recording mood levels, group discussion on self care and healthy relationships)
8. Communicating to health care professionals (lecture, role playing of doctor-patient relationships, group discussion of developing a communications toolkit)
9. "What have I learnt about me?" Integration of learning into a Whole Person perspective (lecture, group work on increased self-awareness and usefulness of cycle knowledge on dimensions of human being.)
- Participants will record fertility obervations daily for 9 weeks (taking approximately 2-3 minutes), and complete a 20 minute reflection exercise according to the cycle phase experienced (approximately one reflection exercise per week). Cervical mucus will be the primary sign of the fertile / infertile phases of the ovulatory menstrual cycle. Students will be asked to observe
(a) vulva sensation of either dryness or slipperiness, and
(b) any presence that they can identify as similar to the faux cervical mucus demonstrated in class.
Secondary signs of fertility / infertility (eg mid cycle pain, breast tenderness) will be suggested for students to observe if experienced.

Location:
- Program delivery will be classroom based in a secondary school during school hours
- Participants will complete their fertility observations and reflection exercises at home

Note:
- the intervention program will be uniformaly delivered and therefore will not be personalised to individual participants
- adherence / fidelity assessment: this is formative research which will trial an ovulatory menstrual health literacy intervention. COREQ is a checklist to report methods, findings, analysis and interpretation [Tong, A., Sainsbury, P., & Craig, J. (2007). Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups. International Journal for Quality in Health Care, 19(6), 349-357.] Process evaluation measures will also be established to protect the intervention program integrity. After each session delivery, a report on adherence to the prescribed program, participant attendance and their responsiveness at each session delivery will also be recorded.
Monitoring of adherence to the at-home component depends on the individual participant's willingness to share personal information. Individual work time will be allocated throughout the class time delivery to allow students to privately approach the facilitator. Improvements in participants' ovulatory menstrual health literacy will be measured quantitatively with a specifically designed pre and post questionnaire.
Intervention code [1] 313267 0
Lifestyle
Intervention code [2] 313268 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 318581 0
Ovulatory menstrual health literacy as measured by a specifically designed questionnaire
Timepoint [1] 318581 0
14 days post completion of intervention
Secondary outcome [1] 365433 0
Ovulatory menstrual knowledge as measured by a specifically designed questionnaire
Timepoint [1] 365433 0
14 days post completion of intervention
Secondary outcome [2] 365434 0
Ovulatory menstrual attitude as measured by a specifically designed questionnaire
Timepoint [2] 365434 0
14 days post delivery of intervention
Secondary outcome [3] 365435 0
Self perceived confidence to communicate ovulatory menstrual health as measured by a specifically designed questionnaire
Timepoint [3] 365435 0
14 days post delivery of intervention

Eligibility
Key inclusion criteria
Students who are enrolled in Grade 9 at the participating school and who have consented to particpate
Minimum age
13 Years
Maximum age
15 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Male students

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

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)
WA

Funding & Sponsors
Funding source category [1] 301570 0
Government body
Name [1] 301570 0
Australian Government Research Training Program
Address [1] 301570 0
Commonwealth Department of Education and Training
50 Marcus Clarke Street
Canberra
ACT 2600
Country [1] 301570 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
School of Public Health
Kent Street
Perth WA 6102
Country
Australia
Secondary sponsor category [1] 301265 0
None
Name [1] 301265 0
Address [1] 301265 0
Country [1] 301265 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302297 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 302297 0
HREC
Kent Street
Perth WA 6102
Ethics committee country [1] 302297 0
Australia
Date submitted for ethics approval [1] 302297 0
16/01/2018
Approval date [1] 302297 0
14/03/2018
Ethics approval number [1] 302297 0
HREC2018-0101

Summary
Brief summary
This study aims to develop and trial an intervention to facilitate ovulatory menstrual (OM) health literacy among 13-16 year old adolescent girls. Based on a whole person framework, the intervention will integrate the spiritual, intellectual, social and emotional dimensions with the physical changes of the OM cycle. The intervention will be trialled with a convenience sample of 120-150 Year 9 female adolescents from a single-sex school. The study hypothesis is that the intervention will facilitate positive attitudes towards OM health and skills to monitor and self-report OM health for confident communication of the common OM disturbances.
Trial website
Trial related presentations / publications
Public notes
Development of the intervention will begin with a critical review of the literature. It will then progress to the use of a Delphi panel of experts and focus groups to sharpen the pedagogy of developing participants’ skills to chart their OM cycle patterns and guide their understanding of their health from a whole person perspective. A questionnaire will also be developed to evaluate the improvement of the adolescents' ovulatory menstrual health literacy post intervention.

Contacts
Principal investigator
Name 89738 0
Mrs Felicity Roux
Address 89738 0
Curtin University
School of Public Health
Kent Street
Perth WA 6102
Country 89738 0
Australia
Phone 89738 0
+61 8 9266 9266
Fax 89738 0
Email 89738 0
Felicity.Roux@postgrad.curtin.edu.au
Contact person for public queries
Name 89739 0
Mrs Felicity Roux
Address 89739 0
Curtin University
School of Public Health
Kent Street
Perth WA 6102
Country 89739 0
Australia
Phone 89739 0
+61 8 9266 9266
Fax 89739 0
Email 89739 0
Felicity.Roux@postgrad.curtin.edu.au
Contact person for scientific queries
Name 89740 0
Mrs Felicity Roux
Address 89740 0
Curtin University
School of Public Health
Kent Street
Perth WA 6102
Country 89740 0
Australia
Phone 89740 0
+61 8 9266 9266
Fax 89740 0
Email 89740 0
Felicity.Roux@postgrad.curtin.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
Condition of ethics approval
What supporting documents are/will be available?
Ethical approval
How or where can supporting documents be obtained?
Type [1] 965 0
Ethical approval
Citation [1] 965 0
Link [1] 965 0
Email [1] 965 0
Other [1] 965 0
Summary results
No Results