Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001443583p
Ethics application status
Not yet submitted
Date submitted
19/11/2024
Date registered
11/12/2024
Date last updated
16/06/2025
Date data sharing statement initially provided
11/12/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the efficacy of an educational app for women with pelvic pain, with or without endometriosis.
Scientific title
Evaluating the efficacy of an educational app for women with pelvic pain, with or without endometriosis.
Secondary ID [1] 308375 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic pelvic pain 328180 0
Endometriosis 335796 0
Pelvic pain 335912 0
Condition category
Condition code
Reproductive Health and Childbirth 325232 325232 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 324832 0
Lifestyle
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333076 0
Changes in pain severity and pain interference (Measured using the Modified Brief Pain Inventory (BPI)).
Timepoint [1] 333076 0
Immediately after completion of 6 week programme (primary timepoint) 6 months after completion 12 months after completion
Primary outcome [2] 341818 0
Changes in pain efficacy (Measured using the Pain Self Efficacy Questionnaire (PSEQ))
Timepoint [2] 341818 0
Immediately after completion of 6 week programme (primary timepoint) 6 months after completion 12 months after completion
Primary outcome [3] 341819 0
Changes in catastrophic thinking related to pain (Measured using the Pain Catastrophizing Scale (PCS))
Timepoint [3] 341819 0
Immediately after completion of 6 week programme (primary timepoint) 6 months after completion 12 months after completion
Secondary outcome [1] 448777 0
Change in inappropriate health service use (measured by self-report of healthcare attendances)
Timepoint [1] 448777 0
6 weeks after program completion, 6 months and 12 months after completion
Secondary outcome [2] 448778 0
Sociocultural appropriateness (measured via semi-structured interviews)
Timepoint [2] 448778 0
6 weeks after program completion (primary time-point)
Secondary outcome [3] 448779 0
PRIMARY outcome: Changes in patient’s perceptions of their own improvement (Measured using the Global Rating of Change (GRC))
Timepoint [3] 448779 0
Immediately following completion of 6 week programme, 6 months post programme completion, 12 months post programme completion (primary time-point)
Secondary outcome [4] 448780 0
PRIMARY outcome: Changes in understanding of pain neuroscience for women with pelvic pain, with or without endometriosis (measured using the Revised Neurophysiology of Pain Questionnaire (NPQ))
Timepoint [4] 448780 0
Immediately post completion of the 6 week programme (primary time-point)
Secondary outcome [5] 448781 0
Patient acceptability (measured via dropout rates, participant feedback, self-report questionnaires, video interviews - assessed together as a composite secondary outcome of acceptability). Drop out rates will be measured by auditing completion of study questionnaires and completion of app sessions (where "app completion" has been deemed completion of over 80% of sessions in the app) Participants will provide free text feedback via a REDCAP questionnaire. Participants will also be offered to provide feedback with a semi-structured interview.
Timepoint [5] 448781 0
Immediately following completion of 6 week programme (primary time-point)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This research will use a within subject, repeated measures design. Repeated measures analysis of variance (ANOVA) will be used to assess the main effect of difference at each data collection time point (pre, post, at six months and 12 months). Where significant main effects were found, post-hoc analyses with Tukey’s HSD Test to look for significant pairwise comparisons within each data set to ascertain where significant change, if present, occurred.

Clinically significant changes will also be ascertained for each measure as per the manuals for each measure.

All questionnaires will be delivered via REDCap where all responses in the PROMs are compulsory (therefore eliminating the risk of missing item responses).

Data will be collected for all participants despite app completeness. For this study app completeness will be defined as completion of over 80% of the sessions within the app.

Open and closed questions about participant experience and sociocultural appropriateness of the app will be collected via free text feedback in REDCap and also through video interviews.

We selected a sample size of 100 participants to maximise the statistical power of our study and ensure the reliability of our results. This number represents the largest cohort that could be accommodated within the funding constraints of our research grant

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2025
Actual
Date of last participant enrolment
Anticipated
3/11/2025
Actual
Date of last data collection
Anticipated
2/03/2026
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 26745 0
New Zealand
State/province [1] 26745 0

Funding & Sponsors
Funding source category [1] 312621 0
University
Name [1] 312621 0
University of Otago
Country [1] 312621 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Country
New Zealand
Secondary sponsor category [1] 320190 0
None
Name [1] 320190 0
Country [1] 320190 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 311940 0
University of Otago Human Ethics Committee (Health)
Ethics committee address [1] 311940 0
Ethics committee country [1] 311940 0
New Zealand
Date submitted for ethics approval [1] 311940 0
25/02/2025
Approval date [1] 311940 0
Ethics approval number [1] 311940 0

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 122910 0
Dr Jessica Theron
Address 122910 0
North Shore Hospital, 124 Shakespeare Road, Takapuna, Auckland 0620
Country 122910 0
New Zealand
Phone 122910 0
+64 225488190
Email 122910 0
jess@ellahealth.co
Contact person for public queries
Name 122911 0
Jessica Theron
Address 122911 0
North Shore Hospital, 124 Shakespeare Road, Takapuna, Auckland 0620
Country 122911 0
New Zealand
Phone 122911 0
+64 225488190
Email 122911 0
jess@ellahealth.co
Contact person for scientific queries
Name 122912 0
Jessica Theron
Address 122912 0
North Shore Hospital, 124 Shakespeare Road, Takapuna, Auckland 0620
Country 122912 0
New Zealand
Phone 122912 0
+64 225488190
Email 122912 0
jess@ellahealth.co

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.