None listed
Conditions
Brief summary
Period pain and symptoms impact many facets of young people’s lives. Early intervention in young people is critical to reducing the lifelong personal and societal impacts of period pain and symptoms and potential secondary causes such as endometriosis. However, problematically, young people do not know how to determine the normality of their menstrual pain, and the severity of impact that requires self management and help-seeking. Timely detection and early intervention for problematic period pain and symptoms may improve the health and wellbeing of young people. The purpose of this research is to conduct a randomised, controlled, three arm pilot trial to investigate the feasibility and acceptability of two web-based menstrual impact screening interventions compared with a control, in young people (14-25 years) with period pain and symptoms.
Interventions
The proposed intervention is the previously validated Period ImPact and Pain Assessment (PIPPA) screening tool that helps young people assess the impact of their menstrual pain and symptoms. PIPPA is a 5-item Y/N dichotomous survey and takes approximately 1-3 minutes to complete. All participants will be screened with PIPPA questions at the beginning of baseline assessments. Because the control group need to be blinded to PIPPA completion, all participants will be blinded to PIPPA questions as they will be part of the baseline set of questions which are the same for all participants and completed prior to randomisation. After randomisation, the intervention will be delivered in two arms: 1. Intervention arm 1 will receive their PIPPA score and score meaning only. 2. Intervention arm 2 will receive their PIPPA score and score meaning as well as access to web pages providing general information about menstrual periods, self-management of menstrual pain and symptoms and a letter with their PIPPA score that can be taken to their GP. • The information provided on the web pages will be written word and photos/pictures (no video) • Anticipated time needed to read the website is approximately 5-20 minutes 3. The control group are not given their PIPPA score or any menstrual information. Arm 1 and Arm 2 will be given their PIPPA score and the score meaning at the time of intervention. Score meaning has small variations between the intervention arms due to Arm 2 having access to additional information and downloads. Arm 1: Your score (out of 5) and score meaning 0 - You don’t really have bothersome symptoms with your period. 1 or 2 - Your symptoms are probably annoying but most likely ‘normal’. You should be able to self-manage occasional symptoms. 3 - Self-management will likely help reduce the impact of your symptoms but if the symptoms persist or worsen, it is recommended you have a discussion with your doctor 4 or 5 - This means your period pain (and other symptoms) have a pretty big impact on your life. Periods should not be this problematic and it is best not to ignore this level of pain. We suggest you make an appointment to speak to your doctor soon. They will be able to investigate further into your pain and symptoms and explore options with you. You should try self-management, track your symptoms and report to your doctor what you have tried and what works for you. Worried? You know your health and your body best. If you are concerned about your periods or pelvic pain, regardless of your period impact score, you should see your doctor to discuss your concerns. Arm 2: You should start the self-management suggestions on this website, track your symptoms and report to your doctor what you have tried and what works for you. Steps to take: • Make an appointment with your doctor • Screenshot your PIPPA score to take to the appointment • Print or download the ‘note for your doctor [PDF 227kB]’ to take to your appointment • Print or download the ‘Managing period pain and symptoms with your doctor [PDF 816kB] (accessible HTML version) resource to take to your appointment. The web pages provided in the Arm 2 intervention are based on a current Canberra Health Services (CHS) website with readily available resources: https://www.canberrahealthservices.act.gov.au/services-and-clinics/services/canberra-endometriosis-centre/period-impact-and-pain-assessment-pippa The CHS web pages were co-designed by healthcare providers, consumers, communications team and online developers. At the end of trial (3 months/Weeks 1-12) and end of follow up (6 months/Weeks 13-24) participants will be re-scored with PIPPA questions, previously listed validated questionnaires, along with other questions regarding actions and outcomes. For intervention Arm 2, access to the PIPPA website will be withdrawn at the end of the trial period (3 months) and no new information will be provided during follow up (Weeks 13-24). A reminder that access is finishing will be sent prior to the end of trial period. Arm 2 will have end of trial questions about whether they found the PIPPA website information and downloads helpful, if they self-managed, spoke to someone about their periods and/or used the letter for their doctor. Arm 1 will have a couple of questions asking if any actions eg seeing a doctor, were a result of receiving a PIPPA score and score meaning. All study participants will complete a similar suite of questions and questionnaires at baseline, 12 weeks and 24 weeks, however there will be some different questions post intervention for Arm 1 and Arm 2 - approximately 3 questions on their thoughts and awareness about their PIPPA impact score and score meaning; At the end of the study, all participants will be offered access to the Canberra Health Services PIPPA web pages. Reference: Parker, M. A., Kent, A. L., Sneddon, A., Wang, J., & Shadbolt, B. (2022). The Menstrual Disorder of Teenagers (MDOT) Study No. 2: Period ImPact and Pain Assessment (PIPPA) Tool Validation in a Large Population-Based Cross-Sectional Study of Australian Teenagers. J Pediatr Adolesc Gynecol, 35(1), 30-38. https://doi.org/10.1016/j.jpag.2021.06.003
Sponsors
Study design
Eligibility
Inclusion criteria
1. Young people aged between 14-25 years 2. Have had menstrual periods for more than 12 months prior to recruitment 3. Had at least 3 menstrual periods/bleeding episodes since menarche 4. Report one or more of the following menstrual issues: a. Pain b. Period symptoms (physical, mental and emotional) c. Heavy menstrual bleeding (HMB) d. Bowel or bladder symptoms with periods 5. Ability to understand and speak English 6. Residing in Australia during the trial period 7. Willing to provide informed consent and adhere to the protocol 8. Has internet access either via a smartphone, tablet, or computer device to access the intervention and complete the questionnaires 9. Capacity to participate (particularly 14-16 year old participants) 10. Participants aged 14-16 (with capacity) who have a parent/carer who can also provide e-consent (in addition to the consent of the young person).
Exclusion criteria
1. Children or adolescents younger than 14 years of age 2. Adults 26 years or older 3. Not currently residing in Australia 4. Not experiencing menstrual pain or other menstrual symptoms 5. Unwilling to adhere to the trial protocol 6. Unwilling or unable to provide informed consent to participate in the study