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DEFINITIONS
Trial Review
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Trial registered on ANZCTR
Registration number
ACTRN12622001149752
Ethics application status
Approved
Date submitted
11/12/2021
Date registered
22/08/2022
Date last updated
22/08/2022
Date data sharing statement initially provided
22/08/2022
Date results information initially provided
22/08/2022
Type of registration
Retrospectively registered
Titles & IDs
Public title
Self-management and self-efficacy in endometriosis
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Scientific title
Self-management and self-efficacy in endometriosis: a quantitative and qualitative study exploring self-efficacy and self-management strategies of women diagnosed with endometriosis
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Secondary ID [1]
305937
0
None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Endometriosis
324531
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Self-management of endometriosis symptoms
324532
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Condition category
Condition code
Mental Health
321998
321998
0
0
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Other mental health disorders
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Reproductive Health and Childbirth
321999
321999
0
0
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Other reproductive health and childbirth disorders
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Mental Health
322000
322000
0
0
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Studies of normal psychology, cognitive function and behaviour
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
The study is split into a quantitative arm and a qualitative arm. The primary aim of the quantitative arm of the study is to investigate factors that are predictive of anxiety and depression amongst those suffering from endometriosis. The anticipated time to complete the online questionnaire is approximately 20 minutes. Participants will only need to complete the one survey. Additionally, the role of self-efficacy will be examined as a potential moderator for symptoms of anxiety and depression. These aims will be investigated using our online questionnaire.
The aim of the qualitative arm of the study will be to determine how women’s self-management of endometriosis has been affected by the COVID-19 pandemic. This aim will be the focus of the semi-structured interview, which is anticipated to take approximately 45-60 minutes. The sem-structured interview will be a once off, delivered via Zoom. Interviews will be completed by a member of the research team, a currently registered provisional psychologist. Participants will be given the opportunity to opt-in following the completion of the quantitative questionnaire. For participants that express interest in the interview, they will be directed to provide their contact details on a secure platform and will then be contacted by a member of the research team.
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Intervention code [1]
322329
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Not applicable
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Comparator / control treatment
N/A
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
329754
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Self-efficacy. Self-efficacy will be assessed using the PROMIS measures of self-efficacy for managing chronic conditions.
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Assessment method [1]
329754
0
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Timepoint [1]
329754
0
This study is not a longitudinal study in nature and does not involve any timepoints. Therefore, all data (such as primary outcome of self-efficacy) will be gathered at baseline.
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Secondary outcome [1]
403662
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The secondary outcome will be psychological distress as measured by symptoms of anxiety and depression. The measure that will be used to assess this outcome will be the DASS-21.
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Assessment method [1]
403662
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Timepoint [1]
403662
0
This study is not a longitudinal study in nature and does not involve any timepoints. Therefore, all data (such as secondary outcomes of psychological distress) will be gathered at baseline.
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Eligibility
Key inclusion criteria
1) Being diagnosed with endometriosis,
2) Aged 18 years or over,
3) Competency of the English language,
4) Access to the internet.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
None
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Study design
Purpose
Psychosocial
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Duration
Cross-sectional
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
Data will be used only by the research team. For the quantitative arm of the study, data will be collected via the secure online RedCap portal from Macquarie University, and used only by the research team. Quantitative data will be analysed using STATA. Initial descriptive analyses of demographic and medical characteristics and bivariate associations of these variables with the study outcomes will be undertaken to identify possible covariates using Pearson’s correlation (continuous variables) and chi-square analyses (categorical variables). Inferential statistics analysis will involve linear regression analyses to determine variables associated with self-care and self-efficacy.
For the qualitative arm of the study, data will be collected via semi-structured interviews conducted over Zoom and saved locally. Interviews will be transcribed to enable subsequent analysis. The qualitative analysis is designed to be exploratory and as such does not test hypotheses and has no outcomes.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
6/04/2022
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Date of last participant enrolment
Anticipated
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Actual
30/06/2022
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Date of last data collection
Anticipated
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Actual
30/06/2022
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Sample size
Target
300
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Accrual to date
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Final
987
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
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Funding & Sponsors
Funding source category [1]
310276
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University
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Name [1]
310276
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Macquarie University
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Address [1]
310276
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Balaclava Rd
Macquarie Park
NSW 2109
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Country [1]
310276
0
Australia
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Primary sponsor type
University
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Name
Macquarie University
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Address
Balaclava Rd
Macquarie Park
NSW 2109
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Country
Australia
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Secondary sponsor category [1]
311383
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None
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Name [1]
311383
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Address [1]
311383
0
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Country [1]
311383
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
309947
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Macquarie University Human Research Ethics Committee
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Ethics committee address [1]
309947
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Balaclava Road, North Ryde
NSW, 2109, Australia
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Ethics committee country [1]
309947
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Australia
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Date submitted for ethics approval [1]
309947
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14/10/2021
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Approval date [1]
309947
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12/01/2022
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Ethics approval number [1]
309947
0
520211078333729
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Summary
Brief summary
The research aims to investigate factors that are predictive of anxiety and depression amongst those suffering from endometriosis. Additionally, the role of self-efficacy will be examined as a potential moderator for symptoms of anxiety and depression . These aims will be the focus of our online questionnaire. The research will also aim to determine how women’s self-management of endometriosis has been affected by the COVID-19 pandemic. This aim will be the focus of the semi-structured interview
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
115946
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Prof Kerry Sherman
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Address
115946
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Centre for Emotional Health
Department of Psychology
Macquarie University
Balaclava Rd
Macquarie Park 2109
New South Wales
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Country
115946
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Australia
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Phone
115946
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+612 9850 6874
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Fax
115946
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Email
115946
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[email protected]
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Contact person for public queries
Name
115947
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Prof Kerry Sherman
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Address
115947
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Centre for Emotional Health
Department of Psychology
Macquarie University
Balaclava Rd
Macquarie Park 2109
New South Wales
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Country
115947
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Australia
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Phone
115947
0
+612 9850 6874
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Fax
115947
0
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Email
115947
0
[email protected]
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Contact person for scientific queries
Name
115948
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Prof Kerry Sherman
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Address
115948
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Centre for Emotional Health
Department of Psychology
Macquarie University
Balaclava Rd
Macquarie Park 2109
New South Wales
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Country
115948
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Australia
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Phone
115948
0
+612 9850 6874
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Fax
115948
0
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Email
115948
0
[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Individual participant data will not be made available as data is to be analysed at the group level, rather than individual level. This will ensure privacy confidentiality for participants are maintained. De-identified data will be made available in a publicly available repository (e.g. OpenScience).
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
14386
Ethical approval
In attached documents
383222-(Uploaded-07-07-2022-20-41-03)-Study-related document.pdf
14387
Informed consent form
In attached documents
383222-(Uploaded-11-12-2021-14-11-06)-Study-related document.docx
14388
Study protocol
In attached documents
383222-(Uploaded-11-12-2021-14-12-44)-Study-related document.docx
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.
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