ongitudinal Study of Teenagers with Endometriosis, Period and Pelvic Pain in Australia (LongSTEPPP)

Not Applicable

Recruiting

• Conditions: dysmenorrhoea; menstrual disorders; pelvic pain; endometriosis; depression; anxiety; personality disorders; chronic pain; Reproductive Health and Childbirth - Menstruation and menopause; Reproductive Health and Childbirth - Other reproductive health and childbirth disorders

• Registration Number: ACTRN12622000362796
• Lead Sponsor: Murdoch Children's Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-01
• Last Update Posted: 8 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 3500

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain – assessed using Periods survey, Paed ePPOC survey and results of Pain-Orientated Sensory Testing (POST) (if available)<br> - The Periods survey has been designed specifically for this study and is not a validated questionnaire nor readily available. <br>-Paediatric electronic Persistent Pain Outcomes Collaboration (ePPOC) is a licensed research data collection tool available at: https://www.uow.edu.au/ahsri/eppoc/<br>citation: University of Wollongong Australia. electronic persistent pain outcomes collaboration (ePPOC). Patient questionnaires. Wollongong: University of Wollongong; 2021.<br>- POST is performed using a calibrated algometer[ 1-year post enrolment];QoL – assessed using Periods survey and the age-appropriate version of the Pediatric Quality of Life Inventory 4.0 (PedsQL).<br>-PaedsQL is a licensed research data collection tool. Research license purchased from custodians Mapi Research Trust.[ 1-year post enrolment]