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Trial registered on ANZCTR


Registration number
ACTRN12619000498190
Ethics application status
Approved
Date submitted
18/03/2019
Date registered
27/03/2019
Date last updated
27/03/2019
Date data sharing statement initially provided
27/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The Prevalence of Central Sensitisation in a Pelvic Pain Cohort; a Pilot Study
Scientific title
The Prevalence of Central Sensitisation in a Pelvic Pain Cohort; a Pilot Study
Secondary ID [1] 297739 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Central Sensitisation 312069 0
Condition category
Condition code
Neurological 310630 310630 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Cross sectional survey of patients presenting with pelvic pain to gynaecology outpatients clinic to determine the prevalence of Central Sensitization (CS) within the cohort. CS describes a condition where the nervous system exists in a state of high reactivity to stimuli. Patients will be recruited after their first clinic appointment and asked to complete a short survery. Recruitment will continue for approximately 6 months until 100 participants have been enrolled. The survey will take 14 minutes to complete and will be only be performed once. There will be no follow up period.
Intervention code [1] 313977 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319479 0
Prevalence of central sensitization as assessed by the central sensitisation inventory
Timepoint [1] 319479 0
At time of survey
Secondary outcome [1] 368639 0
Prevalence of irritable bowel syndrome as assessed by the ROME IV questionnaire
Timepoint [1] 368639 0
At time of survey
Secondary outcome [2] 368640 0
Prevalence of bladder pain syndrome as assessed by the BPIC-SS questionnaire
Timepoint [2] 368640 0
At time of survey
Secondary outcome [3] 368641 0
Prevalence of catastrophising trait as assessed by the Pain Catastrophising Scale
Timepoint [3] 368641 0
At time of survey

Eligibility
Key inclusion criteria
New patients presenting to outpatient gynaecology clinic at the Royal Women's Hospital with pelvic pain
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients aged under 18
- Patients without pelvic pain
- Patients who are non-English speaking and require an interpreter at medical appointments as the questionnaire has not been translated into other languages.
- Any patients who are not ‘new’ appointments as they may already have undergone treatment which may alter the validity of our results

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis
At completion of the study, analysis will involve comparing categorical variables (such as parity, pregnancy loss and history of anxiety and depression) using Chi squared tests and comparing continuous variable measures (such as age and duration of pain) using t-test. If the data does not have a normal distribution then a non-parametric tests such as the Mann Whitney U test will be used. P values of <0.05 will be considered significant. Regression analysis will be used to assess interactions of potential variables of interest.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 13425 0
The Royal Women's Hospital - Parkville
Recruitment postcode(s) [1] 26030 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 302265 0
Hospital
Name [1] 302265 0
The Royal Women’s Hospital Gynae 2 Unit
Address [1] 302265 0
C/O The Royal Women's Hospital
Cnr Grattan St and Flemington Rd
Parkville Vic 3052
Country [1] 302265 0
Australia
Primary sponsor type
Hospital
Name
Royal Women's Hospital
Address
Cnr Grattan St and Flemington Rd
Parkville Vic 3052
Country
Australia
Secondary sponsor category [1] 302128 0
None
Name [1] 302128 0
Address [1] 302128 0
Country [1] 302128 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302941 0
Royal Women's Hospital Human Research and Ethics Committee
Ethics committee address [1] 302941 0
Cnr Grattan St and Flemington Rd
Parkville Vic 3052
Ethics committee country [1] 302941 0
Australia
Date submitted for ethics approval [1] 302941 0
30/10/2018
Approval date [1] 302941 0
17/12/2018
Ethics approval number [1] 302941 0

Summary
Brief summary
Central sensitisation is when normal sensation from an everyday experience such as light touch is increased to produce an abnormally painful response.

This project aims to look at how common (the prevalence) central sensitisation is in women who have pelvic pain. It will also explore other factors that may be associated with a higher risk of central sensitisation, for example, a longer duration of pain, anxiety/depression or a history of other pain conditions e.g. fibromyalgia. The findings will improve the medical knowledge about the role of central sensitisation in the development and experience of pelvic pain.

Participation in this project will involve the following:
- completion of the consent form below
- completion of the questionnaire which will ask about age, demographics, pain history and risk factors, including questions about sensitive issues such as pregnancy loss and abuse. The questionnaire will take about 14 minutes to complete and some of the questions may seem repetitive.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91918 0
Dr Amelia Ryan
Address 91918 0
C/O The Royal Women's Hospital
Cnr Grattan St and Flemington Rd
Parkville 3052
Victoria
Country 91918 0
Australia
Phone 91918 0
+61 383452000
Fax 91918 0
Email 91918 0
amelia.ryan@thewomens.org.au
Contact person for public queries
Name 91919 0
Dr Amelia Ryan
Address 91919 0
C/O The Royal Women's Hospital
Cnr Grattan St and Flemington Rd
Parkville 3052
Victoria
Country 91919 0
Australia
Phone 91919 0
+61 383452000
Fax 91919 0
Email 91919 0
womenshealthresearch@thewomens.org.au
Contact person for scientific queries
Name 91920 0
Dr Amelia Ryan
Address 91920 0
C/O The Royal Women's Hospital
Cnr Grattan St and Flemington Rd
Parkville 3052
Victoria
Country 91920 0
Australia
Phone 91920 0
+61 383452000
Fax 91920 0
Email 91920 0
amelia.ryan@thewomens.org.au

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?
Study protocol
Statistical analysis plan
Informed consent form
Other
'Other' documents specified
Questionnaire
How or where can supporting documents be obtained?
Type [1] 1646 0
Other
Citation [1] 1646 0
Link [1] 1646 0
Email [1] 1646 0
Other [1] 1646 0
Questionnaire
Type [2] 1647 0
Study protocol
Citation [2] 1647 0
Link [2] 1647 0
Email [2] 1647 0
Other [2] 1647 0
Protocol
Type [3] 1648 0
Informed consent form
Citation [3] 1648 0
Link [3] 1648 0
Email [3] 1648 0
Other [3] 1648 0
PICF
Summary results
No Results