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Evaluating the efficacy of an educational app for women with pelvic pain, with or without endometriosis.

Evaluating the efficacy of an educational app for women with pelvic pain, with or without endometriosis.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624001443583
Enrollment
100
Registered
2024-12-11
Start date
2025-07-01
Completion date
2025-11-03
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Our aim is to evaluate whether education on pain neuroscience and adaptive self-management. strategies delivered via a mobile phone application will improve reported pain interference, pain self-efficacy, pain related catastrophic worry and ratings of physical ability and overall well-being for women with pelvic pain, with or without endometriosis. We hypothesise that completing a six-week education program delivered through a mobile app, focusing on understanding pelvic pain and learning strategies to manage it, will lead to improved outcomes for women with pelvic pain. This includes reduced pain severity, less worry about pain, greater confidence in managing pain, and a lower impact of pain on daily life. We also expect participants to report fewer healthcare visits, take less time off work due to pain, and to find the program helpful and easy to use.

Interventions

Interested participants will be emailed baseline measures to complete before starting the program. They will be asked to complete the Brief Pain Interference (BPI) score weekly for four weeks, and the average score from these four weeks will be used as the baseline BPI measure. If participants complete these baseline measures, they will be provided with access to a smartphone app-based six-week education program designed to be used alongside usual care provided by their primary care team. Foll

Interested participants will be emailed baseline measures to complete before starting the program. They will be asked to complete the Brief Pain Interference (BPI) score weekly for four weeks, and the average score from these four weeks will be used as the baseline BPI measure. If participants complete these baseline measures, they will be provided with access to a smartphone app-based six-week education program designed to be used alongside usual care provided by their primary care team. Following completion of the app, participants will repeat the measures, alongside the revised neurophysiology of pain questionnaire (NPQ). At six and twelve months later, they will complete the same measures again along with two global rating of change scales to evaluate their progress. The digital pain management program uses the same evidence-based content as the PIPPI program, an in-person pain management program specifically developed for women with chronic pelvic pain. The Ella App was built in partnership with the clinicians who designed the PIPPI program. The program is grounded in a Cognitive Behavioural model and covers a range of topics including pain neuroscience education, gentle graded exercises and stretches developed by women’s health physiotherapists, relaxation and mindfulness exercises, sleep and stress management, as well as communication and problem-solving strategies. Pain neuroscience education is delivered through written content. Graded exercises and stretches are provided via short instructional videos, while relaxation and mindfulness sessions are available as audio recordings. Sleep and stress management, communication, and problem-solving are addressed using a cognitive behavioral approach, with written content and worksheets that participants can complete in their own time. Participants are encouraged to engage with the program five days a week for six weeks. New content is "unlocked" daily, and each day's material takes approximately 20 minutes to complete. To monitor adherence to the intervention, app usage data will be analyzed to measure parameters such as the percentage of participants who complete the entire program and their engagement levels throughout. For the purpose of this study, 'standard care' refers to the care typically available to women with chronic pelvic pain in a non-research setting. This includes consultations with general practitioners and gynecologists, the use of hormonal therapies such as the oral contraceptive pill, pain relief medications, physiotherapy, and surgical interventions like diagnostic laparoscopy and/or excision surgery. This standard of care serves as the baseline against which the impact of the education program will be assessed.

Sponsors

University of Otago
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Primary purpose
Educational / counselling / training

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

Criteria include: - Female - Aged between 18 - 50 years old - English speaking - Able to give informed consent - Able to use digital device - Abdomino-pelvic pain for over 6 months - Accepting of the concept of digital delivery of a pain self-management program

Exclusion criteria

Exclusion criteria: - Unable to give informed consent - Poor literacy or limited English - Significant current mental health condition - Awaiting acute surgical intervention - Un-investigated “red flags” for serious disease - Unable to safely participate in exercise - Unable to use digital device - Current or past cancer - Currently pregnant - Having previously done a pain management program

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026