None listed
Conditions
Brief summary
This study aims to evaluate a new package of care designed to improve menstrual health literacy and support earlier identification of heavy menstrual bleeding (HMB). Participants will track their menstrual symptoms using a digital diary, access educational resources, and attend a specialist medical assessment. The study will assess whether this approach is acceptable, feasible, and safe for individuals experiencing possible HMB. It will also explore whether the program improves help-seeking behaviour, symptom management, and understanding of menstrual health. We hypothesise that this integrated approach will support better recognition of symptoms and encourage timely access to appropriate care.
Interventions
Participants will receive a four-component intervention delivered alongside usual care over approximately 13–16 weeks (equivalent to three menstrual cycles). For the purposes of this study, usual care is defined as any healthcare or self-management participants would typically access independently, including general practitioner consultations, over-the-counter treatments, or specialist referrals, without direction from the research team.
The intervention comprises: (1) a digital menstrual diary
Participants will receive a four-component intervention delivered alongside usual care over approximately 13–16 weeks (equivalent to three menstrual cycles). For the purposes of this study, usual care is defined as any healthcare or self-management participants would typically access independently, including general practitioner consultations, over-the-counter treatments, or specialist referrals, without direction from the research team. The intervention comprises: (1) a digital menstrual diary completed via REDCap; (2) menstrual product use tracking (using either study-provided or participant-selected products); (3) access to evidence-based menstrual health education resources; and (4) a specialist medical consultation. Participants will complete the digital menstrual diary daily during menstruation throughout the 12-week intervention period, capturing bleeding patterns, symptoms, quality of life impacts, and product/medication use. Validated measures embedded within REDCap include the Pictorial Blood Assessment Chart (PBAC), SAMANTA questionnaire, and Menstrual Bleeding Questionnaire (MBQ). Participants will be given the option to use study-provided commercially available tampons and pads or their own preferred products, with product type and usage recorded to support interpretation of menstrual bleeding patterns. Participants will receive access to curated, evidence-based menstrual health education resources delivered online. These resources are readily available (not developed specifically for this study) and include materials from reputable sources covering topics such as normal versus abnormal menstrual bleeding, recognition of heavy menstrual bleeding symptoms, when to seek medical care, self-management strategies, and understanding menstrual cycle physiology. Resources will be provided in multiple formats, including written information and web-based content, and participants will be encouraged to engage with these materials throughout the 12-week intervention period. Following completion of the diary and education components, participants will attend a medical consultation at a specialist women’s health clinic (Women’s Health Road) within Weeks 13–16 of the study period for comprehensive assessment and clinical diagnosis by a gynaecologist. This will include review of medical history, symptom assessment, and where appropriate, pelvic ultrasound. If recent testing is unavailable, participants will be offered venous blood testing (full blood count and iron studies) to assess iron status in relation to menstrual bleeding. Adherence to intervention components will be monitored via REDCap completion rates for the digital diary and questionnaires, and through tracking of engagement with educational resources where possible.
Sponsors
Western Sydney University
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants must meet all the following inclusion criteria prior to study entry to be eligible for enrolment: • Aged 18 years or over • Regular menstrual periods (21-34 days) • Individuals who self-report symptoms consistent with possible heavy menstrual bleeding having one or more of the following symptoms: periods lasting more than 7 days, needing to change pads/tampons more frequently than every 2 hours, passing large clots, or experiencing significant disruption to daily activities but who have not received a formal clinical diagnosis of heavy menstrual bleeding. • Able to use tampons and/or pads • Willing to attend Women’s Health Road (WHR) for consultation • Experienced menarche at least 12 months prior to recruitment • Had at least 3 menstrual periods since menarche • Willing to provide informed consent and adhere to protocol • Access to smartphone, tablet, or computer with internet connectivity
Exclusion criteria
Participants presenting with any of the following will be excluded from participating: • Current pregnancy or breastfeeding • Planning pregnancy during study period • Current use of menstrual suppression therapy • Significant cognitive impairment affecting ability to complete questionnaires • Non-English speaking (insufficient English comprehension for questionnaire completion)
Outcome results
None listed