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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
11/12/2024
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, and 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
Reduction of impact of chronic pelvic pain on quality of life (Measured via self-report questionnaires of psychosocial correlates of pain)
Timepoint [1] 333076 0
Immediately after completion of 6 week programme (primary timepoint)
6 months after completion
12 months after completion
Primary outcome [2] 333077 0
Reduction of inappropriate health service use (Measured by self-report of healthcare attendances)
Timepoint [2] 333077 0
6 months after completion (primary timepoint)
12 months after completion
Primary outcome [3] 333078 0
Patient acceptability (Measured via dropout rates, participant feedback, and self-report questionnaire)
Timepoint [3] 333078 0
Immediately after completion of 6 week programme (primary timepoint)
Secondary outcome [1] 415720 0
Global rating of change (measured with Global Rating of change scales)
Timepoint [1] 415720 0
Immediately after completion of 6 week programme
6 months after completion

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.

Qualitative information resulting from open ended questions and free text will be used to ascertain acceptability and sociocultural appropriateness of the app.

We selected a sample size of 200 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
1/01/2025
Actual
Date of last participant enrolment
Anticipated
28/02/2025
Actual
Date of last data collection
Anticipated
28/11/2025
Actual
Sample size
Target
200
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
Address
Country
New Zealand
Secondary sponsor category [1] 320190 0
None
Name [1] 320190 0
Address [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
20/12/2024
Approval date [1] 311940 0
Ethics approval number [1] 311940 0

Summary
Brief summary
Trial website
Trial related presentations / publications
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
Fax 122910 0
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
Fax 122911 0
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
Fax 122912 0
Email 122912 0
jess@ellahealth.co

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.