Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000455460
Ethics application status
Approved
Date submitted
11/04/2025
Date registered
14/05/2025
Date last updated
14/05/2025
Date data sharing statement initially provided
14/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility and Acceptability of a Digital Holistic Prehabilitation and Rehabilitation Program for Endometriosis Surgery Patients
Scientific title
Feasibility and Acceptability of a Digital Holistic Prehabilitation and Rehabilitation Program for Endometriosis Surgery Patients
Secondary ID [1] 314105 0
nil known
Universal Trial Number (UTN)
U1111-1321-3413
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
endometriosis 336890 0
Condition category
Condition code
Surgery 333362 333362 0 0
Other surgery
Reproductive Health and Childbirth 333657 333657 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will voluntarily enrol into a a holistic digital prehabilitation and rehabilitation program tailored to people undergoing surgery for suspected endometriosis, called the Matilda program (www.matilda.health). The resources are housed within the Matilda App and have all been created for the Matilda program.
The Matilda program includes
1. Prehabilitation (4 weeks pre-surgery):
a. Self-guided yoga and Pilates sessions (30 minutes, 2x/week).
b. Mindfulness and relaxation techniques (self-guided meditations). This includes ~5-20 mins of mindfulness/relaxation techniques provided per week, with the frequency self determined by the participant
c. Educational modules delivered via short video lectures (with subtitles) and accompanying text documents that provide information on
i. Pelvic floor anatomy and how to best use the pelvic floor for the participant's needs
ii. Optimal diet
iii. Understanding the pain system,
iv. Stress management,
v. Physical activity/movement,
vi. Pre-anaesthetic appointment navigation,
vii. Logistics regarding hospital stay for surgery,
viii. What support systems are available and how to best navigate them
ix. Gas pain – what it is and how to manage it,
x. Psychological Health management: Navigating a diagnosis (or no diagnosis)

d. Lifestyle tracking (movement, nutrition, mental wellbeing, sleep), completed. These will be tracked within the Matilda App (ie the same App that the educational content and mindfulness/relaxation techniques are housed on).

e. Lived experience pre-recorded interviews from people who have previously had surgery for their endometriosis. These interview videos will be housed within the Matilda App

f. Weekly clinician-led video conference group calls, delivered as weekly online calls with up to 50 participants.

g. Peer support via a community forum with forum messages moderated by a member of the research team and by a community lead and filters have been set up to flag/ban certain words (i.e. profanities or racist comments This is available only to those within the program, and is a separate community forum platform (Slack)

h. Weekly check-ins via email and SMS to encourage engagement.

2. Rehabilitation (4 weeks post-surgery):

a. Progressive Yoga and Pilates. These sessions are lighter and easier than the prehabilitation classes in order to accommodate the post-surgery period. The participants are encouraged within the Matilda App to determine their own level of participation according to what works for their body, starting with less and then building slowly.

b. Mindfulness and relaxation techniques. As per the prehabilitation sessions there are 5 to 20 minutes duration and the frequency determined by participant preference.

c. Educational modules delivered via short video lectures (with subtitles) and accompanying text documents that provide information on
i. What is endometriosis,
ii. Return to movement,
iii. Healing foods,
iv. Wound care,
v. Returning to sex,
vi. Maintaining long term changes,
d. Weekly clinician-led video conference group calls, delivered as weekly online calls with up to 50 participants.
e. Peer support via a community forum with forum messages moderated by a member of the research team and by a community lead and filters have been set up to flag/ban certain words (i.e. profanities or racist comments This is available only to those within the program, and is a separate community forum platform (Slack).
f. Weekly check-ins via email and SMS to encourage engagement.
Intervention code [1] 330767 0
Rehabilitation
Comparator / control treatment
The comparator will involve participants who do not enrol in the Matilda program. Participants in this arm of the study would be free to conduct their own prehabilitation and or rehabilitation, sourcing health professional help as they would like. Participants who do not enrol in the Matilda program do not have access to the program resources, as the resources sit behind a pay wall.
Control group
Active

Outcomes
Primary outcome [1] 341041 0
Quality of Life
Timepoint [1] 341041 0
1 Baseline demographic survey for all participants undergoing laparoscopic surgery (Timepoint 1) 2. End of Prehab Survey for all participants undergoing laparoscopic surgery (Timepoint 2: approximately four weeks post timepoint 1, before surgery). 3. End of Program Survey for all participants undergoing laparoscopic surgery (Timepoint 3: 4 weeks post-surgery)
Primary outcome [2] 341043 0
Change in composite score of most troublesome symptoms
Timepoint [2] 341043 0
1 Baseline demographic survey for all participants undergoing laparoscopic surgery (Timepoint 1) 2. End of Prehab Survey for all participants undergoing laparoscopic surgery (Timepoint 2: approximately four weeks post timepoint 1, before surgery). 3. End of Program Survey for all participants undergoing laparoscopic surgery (Timepoint 3: 4 weeks post-surgery)
Primary outcome [3] 341044 0
Average pain over the last week
Timepoint [3] 341044 0
1 Baseline demographic survey for all participants undergoing laparoscopic surgery (Timepoint 1) 2. End of Prehab Survey for all participants undergoing laparoscopic surgery (Timepoint 2: approximately four weeks post timepoint 1, before surgery). 3. End of Program Survey for all participants undergoing laparoscopic surgery (Timepoint 3: 4 weeks post-surgery)
Secondary outcome [1] 445934 0
Self rated anxiety over the last week
Timepoint [1] 445934 0
1 Baseline demographic survey for all participants undergoing laparoscopic surgery (Timepoint 1) 2. End of Prehab Survey for all participants undergoing laparoscopic surgery (Timepoint 2: approximately four weeks post timepoint 1, before surgery).
Secondary outcome [2] 445937 0
Self-Efficacy for Managing Chronic Diseases
Timepoint [2] 445937 0
1 Baseline demographic survey for all participants undergoing laparoscopic surgery (Timepoint 1) 2. End of Prehab Survey for all participants undergoing laparoscopic surgery (Timepoint 2: approximately four weeks post timepoint 1, before surgery). 3. End of Program Survey for all participants undergoing laparoscopic surgery (Timepoint 3: 4 weeks post-surgery)
Secondary outcome [3] 445938 0
Self rated anxiety in regards to surgery
Timepoint [3] 445938 0
Baseline demographic survey for all participants undergoing laparoscopic surgery (Timepoint 1) End of Prehab Survey for all participants undergoing laparoscopic surgery (Timepoint 2: approximately four weeks post timepoint 1, before surgery). End of Program Survey for all participants undergoing laparoscopic surgery (Timepoint 3: 4 weeks post-surgery)
Secondary outcome [4] 445939 0
Confidence in managing pre- and post-surgery care
Timepoint [4] 445939 0
Baseline demographic survey for all participants undergoing laparoscopic surgery (Timepoint 1) End of Prehab Survey for all participants undergoing laparoscopic surgery (Timepoint 2: approximately four weeks post timepoint 1, before surgery). End of Program Survey for all participants undergoing laparoscopic surgery (Timepoint 3: 4 weeks post-surgery)
Secondary outcome [5] 446164 0
Acceptability will be asked of all the participants who enrol in the Matilda program and will not be asked of the participants who do not enrol in the Matilda program
Timepoint [5] 446164 0
End of Prehab Survey for all participants undergoing laparoscopic surgery (Timepoint 2: approximately four weeks post timepoint 1, before surgery). End of Program Survey for all participants undergoing laparoscopic surgery (Timepoint 3: 4 weeks post-surgery)
Secondary outcome [6] 446901 0
Feasibility will be asked of all the participants who enrol in the Matilda program and will not be asked of the participants who do not enrol in the Matilda program
Timepoint [6] 446901 0
End of Prehab Survey for all participants undergoing laparoscopic surgery (Timepoint 2: approximately four weeks post timepoint 1, before surgery). End of Program Survey for all participants undergoing laparoscopic surgery (Timepoint 3: 4 weeks post-surgery)
Secondary outcome [7] 447165 0
Percentage of modules completed within the Matilda App will be gathered in all the participants who enrol in the Matilda program and will not be asked of the participants who do not enrol in the Matilda program
Timepoint [7] 447165 0
Timepoint 2: approximately four weeks post timepoint 1, before surgery). Timepoint 3: 4 weeks post-surgery
Secondary outcome [8] 447166 0
Number of participants who enter the trial per week
Timepoint [8] 447166 0
At weekly intervals from start of trial for 6 months

Eligibility
Key inclusion criteria
The inclusion criteria are those scheduled for laparoscopic surgery for suspected endometriosis
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People who do not have access to a smartphone, electronic device or computer with internet connectivity. The exclusion criteria include people who are non-English speakers (due to language limitations in the program) and those aged under 18.

Study design
Purpose of the study
Treatment
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
It is anticipated that 30 people who are scheduled for laparoscopic surgery will be required to provide a representative sample. This is the median target sample size of two armed studies examined in a review examining sample size of feasibility studies (Totton etal 2023)
• Quantitative Data: Descriptive statistics will be generated for recruitment rates, adherence,, demographics, limited efficacy testing variables (pain, anxiety, self efficacy, rating of most troublesome symptoms, quality of life,) acceptability and feasibility scales. Data will be examined for normality, with continuous data that is not normally distributed reported using Median (quartile one, quartile three). Continuous data that is normally distributed will be reported using Mean (standard deviation). Differences between the groups (those that did the Matilda program and those that did not) in the limited efficacy testing variables will be examined using Stata (StataCrop, College Station, TX) with a generalised linear mixed model (GLMM) analysis.
• Qualitative Data: Content inductive analysis of open-ended text box responses will be conducted using two independent coders who will use an iterative six-stage process which includes data familiarisation, generation of initial codes, generating themes, reviewing concepts, defining, and naming conceptual themes and report production(Hsieh and Shannon 2005, Braun and Clarke 2006, Nowell, Norris et al. 2017)
• Merging integration: Findings from quantitative and qualitative data will be integrated to compare, complement, and triangulate results, ensuring a comprehensive understanding of the feasibility and acceptability of the intervention, using joint displays as recommended by prior authors(Aschbrenner, Kruse et al. 2022) .

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/05/2025
Actual
Date of last participant enrolment
Anticipated
3/08/2025
Actual
Date of last data collection
Anticipated
3/11/2025
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 26956 0
New Zealand
State/province [1] 26956 0
Country [2] 26957 0
United Kingdom
State/province [2] 26957 0

Funding & Sponsors
Funding source category [1] 318611 0
Commercial sector/Industry
Name [1] 318611 0
Matilda program
Country [1] 318611 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Country
Australia
Secondary sponsor category [1] 321109 0
None
Name [1] 321109 0
Address [1] 321109 0
Country [1] 321109 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317215 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 317215 0
Ethics committee country [1] 317215 0
Australia
Date submitted for ethics approval [1] 317215 0
03/01/2025
Approval date [1] 317215 0
04/03/2025
Ethics approval number [1] 317215 0
HRE2025-0071

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 140370 0
Dr Leanda McKenna
Address 140370 0
Curtin University, GPO Box U1987, Perth, Western Australia 6845.
Country 140370 0
Australia
Phone 140370 0
+61 8 92663660
Fax 140370 0
Email 140370 0
[email protected]
Contact person for public queries
Name 140371 0
Leanda McKenna
Address 140371 0
Curtin University, GPO Box U1987, Perth, Western Australia 6845.
Country 140371 0
Australia
Phone 140371 0
+61 8 92663660
Fax 140371 0
Email 140371 0
[email protected]
Contact person for scientific queries
Name 140372 0
Leanda McKenna
Address 140372 0
Curtin University, GPO Box U1987, Perth, Western Australia 6845.
Country 140372 0
Australia
Phone 140372 0
+61 8 92663660
Fax 140372 0
Email 140372 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: with a small sample of a specific targetted demographic, it may be possible to identify the individual participants



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.