None listed
Conditions
Brief summary
LongSTEPPP tracks young people’s development and trajectories of period and pelvic pain, and endometriosis with current gynaecological care. The study investigates multiple individual and family characteristics for each participant. By tracking participants over time, we will be able to determine factors associated with pain, quality of life (QoL), mental health, and health utilisation. The study aims to establish a comprehensive national cohort of young people seeing a health care provider, for the management of period or pelvic pain or endometriosis, establishing baseline characteristics and exploring longer term outcomes. The health care provider may be a general practitioner (GP), a federally funded Endometriosis and Pelvic Pain GP Clinic (EPPC), a gynaecologist or paediatrician. This reflects the evolving landscape of service provision for these conditions. LongSTEPPP will commence in 2022 with a single cohort of young people aged 10 to 18-years. Participants will be invited from across Australia. Data will be collected annually. Study participants include the young person and the female parent/guardian. LongSTEPPP data will be linked to sources of administrative data including the Medical Benefits Schedule (MBS) and the Pharmaceutical Benefits Schedule (PBS).
Interventions
Participants are asked to complete questionnaires at baseline and annually thereafter for up to 5 years (or until 31/12/2027). The questionnaires cover periods, pain, quality of life, depression, anxiety, personality traits and adverse childhood events. The number of questionnaires depends on the age of the participant and is detailed in the study protocol and accompanying PICFs.
-For child/young person the questionnaires for the research project will take around 45 minutes of the child’s time,
Participants are asked to complete questionnaires at baseline and annually thereafter for up to 5 years (or until 31/12/2027). The questionnaires cover periods, pain, quality of life, depression, anxiety, personality traits and adverse childhood events. The number of questionnaires depends on the age of the participant and is detailed in the study protocol and accompanying PICFs. -For child/young person the questionnaires for the research project will take around 45 minutes of the child’s time, per year. -For parent/guardian the questionnaires for the research project will take around 30 minutes of your time, per year. The mode of delivery for all questionnaires is via email for completion online. Participants are also invited to participate in pain-orientated sensitivity testing (POST) which is performed face-to-face using a calibrated algometer. POST appointments take up to 30 minutes for both the child/young person and their parent/guardian. Health care utilisation (for children/young people) will be assessed by data linkage to Medicare Benefits Scheme (MBS) and Pharmaceutical Benefits Scheme (PBS) data. This requires the participant or parent/guardian (depending on age) to complete a separate participant consent form for the release of Services Australia information.
Sponsors
Murdoch Children's Research Institute
Eligibility
Sex/Gender
All
Age
10 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Each young person must meet all the following criteria to be enrolled in the LongSTEPPP study: • Is between the ages of 10 and 18-years at enrolment • Has seen a GP or has a referral to: an endometriosis and pelvic pain GP clinic (EPPC) a gynaecologist or paediatrician for dysmenorrhoea, period, or pelvic pain, or suspected or proven endometriosis from another health clinician. • Can read and understand English, with proficiency enough to understand the Participant Information Statements, make an informed decision about completing the questionnaires and has the ability to complete the questionnaires; and • The young person and parent/guardian provide informed consent, or the young person demonstrates maturity and capacity to consent and provides informed consent (as a mature minor). We will also be recruiting female parents/guardians of enrolled young people who must meet all the following criteria to be enrolled in the LongSTEPPP study: • Can read and understand English, with proficiency enough to understand the Participant Information Statements, make an informed decision about completing the questionnaires and ability to complete the questionnaires; and • Demonstrates maturity and capacity to consent and provides informed consent.
Exclusion criteria
Participants meeting any of the following criteria will be excluded from LongSTEPPP: • Absent uterus (Mayer-Rokitansky-Küster-Hauser (MRKH) syndrome or Androgen Insensitivity Syndrome • Referral to a gynaecologist for oncofertility/fertility preservation • Intellectual disability or global developmental delay.
Outcome results
None listed