Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000794707
Ethics application status
Approved
Date submitted
27/05/2022
Date registered
6/06/2022
Date last updated
13/07/2023
Date data sharing statement initially provided
6/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The prevalence, impact, and associated factors of pelvic floor disorders in Australian performing artists: A cross-sectional study.
Scientific title
The prevalence, impact, and associated factors of pelvic floor disorders in Australian performing artists: A cross-sectional study.
Secondary ID [1] 307237 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pelvic Floor Disorders 326487 0
Condition category
Condition code
Public Health 323755 323755 0 0
Epidemiology
Renal and Urogenital 323781 323781 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
a) Participant group of interest: Australian Performing Artists (over the age of 18 years).

b) The sample will be selected via a non-probability sampling technique, recruiting through performing arts schools, and professional companies with approval from the managers or Artistic Directors. All performing artists will be invited to participate. The aim of this approach is to attract eligible participants directly. The administration team at each performing arts company will distribute the questionnaire to their artists via email and/or newsletter with a link to the questionnaire. The questionnaire will also be advertised through social media (Facebook, LinkedIn, Twitter, Instagram) to performing artists, through targeted advertising strategies using hashtags and posting in relevant groups. Interested performing artists can email the lead researcher if they have queries and the questionnaire will be able to be completed after providing informed consent, which will be embedded within the questionnaire.

c) Outcomes to be assessed:

Part 1:
• To investigate the prevalence of pelvic floor disorders in Australian performing artists.
• To identify the factors associated with the presence of pelvic floor disorders in performing artists.
• To explore the impact pelvic floor disorders have on performing artists’ performance, training and everyday activities.
Part 2:
• To explore if there are barriers to performing artists accessing care for the management of pelvic floor disorders.

These outcomes will be assessed via completion of questionnaires.

d) Time commitment: Approximately 30 minutes

e) The questionnaire will be completed via an online link

f) Cross-sectional study
Intervention code [1] 323680 0
Diagnosis / Prognosis
Comparator / control treatment
Comparisons will be made between participants based on their primary performing art genre.
Control group
Active

Outcomes
Primary outcome [1] 331512 0
Lower urinary tract symptoms
Lower urinary tract symptoms assessed using the ICI Questionnaire Male Lower Urinary Tract Symptoms Module (ICIQ-MLUTS) for participants with external male genitalia or the ICI Questionnaire Female Lower Urinary Tract Symptoms Module (ICIQ-FLUTS) for participants with external female genitalia
Timepoint [1] 331512 0
Once at the time of enrolment
Primary outcome [2] 331544 0
The Bowel Control Self-Assessment (Grade B recommendation for use) for all participants
Timepoint [2] 331544 0
Once at time of enrolment
Primary outcome [3] 331545 0
Pelvic floor pain
Pelvic floor pain assessed using one question from the PUF
Timepoint [3] 331545 0
Only once at time of enrolment
Secondary outcome [1] 410139 0
Impact of pelvic floor disorders (PFD) on performance and training
Impact on performing and training data will be analysed through descriptive analysis of questions developed by the research team.
Timepoint [1] 410139 0
Once only at the time of enrolment
Secondary outcome [2] 410219 0
Impact of PFD on everyday life
Impact on everyday lift will be reviewed through the PFIQ-7
Timepoint [2] 410219 0
Only once at time of enrolment
Secondary outcome [3] 410220 0
Dyspareunia (Primary outcome)
Assessed through a question from the PFBQ
Timepoint [3] 410220 0
Only once at time of enrolment
Secondary outcome [4] 410221 0
Pelvic organ prolapse (primary outcome)
Assessed through a question from the PFBQ
Timepoint [4] 410221 0
Only once at time of enrolment
Secondary outcome [5] 410222 0
General exercise load
Assessed through whether the exercise guidelines are being met (yes/no)
Timepoint [5] 410222 0
Only once at the time of enrolment
Secondary outcome [6] 410223 0
Training load
Assessed through questions developed by the research team
Timepoint [6] 410223 0
Only once at the time of enrolment
Secondary outcome [7] 410224 0
Vaginal Wind (Primary outcome)
Assessed through a question developed by the research team
Timepoint [7] 410224 0
Only once at time of enrolment
Secondary outcome [8] 410225 0
Hormonal status
Assessed through questions from the DEAQ
Timepoint [8] 410225 0
Only once at time of enrolment
Secondary outcome [9] 410227 0
Disordered eating and low relative energy availability
Assessed through the restricted eating section of the EDE-Q
Timepoint [9] 410227 0
Only once at the time of enrolment
Secondary outcome [10] 410228 0
Hypermobility
Assessed through the 5-part questionnaire for identifying hypermobility
Timepoint [10] 410228 0
Only once at time of enrolment
Secondary outcome [11] 410233 0
Compensatory strategies
Assessed by questions developed by the research team
Timepoint [11] 410233 0
Only once at time of enrolment
Secondary outcome [12] 410234 0
Pelvic floor symptom disclosure
Assessed by questions developed by the research team
Timepoint [12] 410234 0
Only once at time of enrolment
Secondary outcome [13] 410235 0
Pelvic floor awareness and training
Assessed by questions developed by research team
Timepoint [13] 410235 0
Only once at time of enrolment
Secondary outcome [14] 410236 0
Health literacy
Assessed by question developed by the research team
Timepoint [14] 410236 0
Only once at time of enrolment
Secondary outcome [15] 410237 0
Impact of PFD on everyday life
Impact on everyday lift will be reviewed through the IIQ-7.
Timepoint [15] 410237 0
Only once at time of enrolment

Eligibility
Key inclusion criteria
Australian performing artists from any discipline will be invited to participate in the study if they meet the inclusion criteria; be at least 18 years of age and currently training, studying, or working as a performing artist.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Unable to complete an online questionnaire due to internet, electronic device availability or English proficiency.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
This study is cross-sectional in design, using an anonymous online questionnaire that will be purpose-designed and include sections developed by the expert research team as well as validated outcome measures where they exist.

Sociodemographic and health data questions will be developed by the expert research team with guidance from a previously published questionnaire (Dakic et al., 2021). Participant characteristics will include age, body-mass index (BMI), education level, sex, and gender. Medical and pelvic health data will include pelvic health conditions, previous pelvic surgeries, and obstetric history, as these factors may independently impact the odds of developing PFD.

Piloting:
The questionnaire will be piloted with performing artists and this piloting phase will allow the research team to collect feedback on understanding, clarity, length, and layout and make amendments accordingly.

Sample size:
The proposed sample size is 384, based on the conservative prevalence of 20% (urinary continence and/or anal incontinence) (Skaug et al., 2021) a conservative precision estimate of 4% and a confidence interval of 95% (Pourhoseingholi et al., 2013). Given that 2011 national data reported up to 16,000 Australians were employed as performing artists (this figure does not include amateur artists), the proposed sample size is feasible (Australian Bureau of Statistics., 2014). The sample will be selected via a non-probability sampling technique, recruiting through performing arts schools, and professional companies with approval from the managers or Artistic Directors. All performing artists will be invited to participate. The aim of this approach is to attract eligible participants directly. The administration team at each performing arts company will distribute the questionnaire to their artists via email and/or newsletter with a link to the questionnaire. The questionnaire will also be advertised through social media (Facebook, LinkedIn, Twitter, Instagram) to performing artists, through targeted advertising strategies using hashtags and posting in relevant groups. Interested performing artists can email the lead researcher if they have queries and the questionnaire will be able to be completed after providing informed consent, which will be embedded within the questionnaire.

Analysis Plan:

REDCap data will be extracted and collated into an excel spreadsheet for data analysis. The proposed analysis will be completed using SPSS Statistical Software (version 28) and will involve both descriptive analysis and inferential statistics.

Primary performing art genre will be analysed as per the questionnaire and also collapsed into large artistic categories: dance, music, circus, and theatre for analysis. Sociodemographic variables will be presented as numbers with percentages or means with standard deviation (SD) or median (IQR) if not normally distributed. Prevalence of each PFD (lower urinary tract symptoms, bowel symptoms, pelvic floor pain, pelvic organ prolapse (POP), and dyspareunia) will be reported as frequency and percentage and comparisons between artistic group with PFD (yes/no) explored using chi squared analysis. Associated factors will be explored using multivariate binary logistic regression (PFD yes/no) and reported as odds ratio with 95% confidence intervals with categorical factors, such as performing arts type, gender, parity and activity levels and continuous covariates for example BMI explored. Alpha will be set at 0.05.

Descriptive analysis will be used to report on compensatory strategies, bother and impact of PFD in performing artists, and part two of the questionnaire.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
29/08/2022
Actual
19/10/2022
Date of last participant enrolment
Anticipated
31/08/2023
Actual
Date of last data collection
Anticipated
31/07/2024
Actual
Sample size
Target
384
Accrual to date
188
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 311538 0
University
Name [1] 311538 0
La Trobe University
Country [1] 311538 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Plenty Rd &, Kingsbury Dr, Bundoora VIC 3086, Australia
Country
Australia
Secondary sponsor category [1] 312950 0
None
Name [1] 312950 0
Address [1] 312950 0
Country [1] 312950 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310993 0
Human Research Ethics Committee (HREC) La Trobe University
Ethics committee address [1] 310993 0
Ethics committee country [1] 310993 0
Australia
Date submitted for ethics approval [1] 310993 0
31/05/2022
Approval date [1] 310993 0
29/08/2022
Ethics approval number [1] 310993 0
HEC22166

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

Contacts
Principal investigator
Name 119618 0
Ms Jessica Frydenberg
Address 119618 0
18 Physio
322 Glenferrie Road, Malvern VIC 3144
Country 119618 0
Australia
Phone 119618 0
+61 431614281
Fax 119618 0
Email 119618 0
jessfrydenberg@gmail.com
Contact person for public queries
Name 119619 0
Jessica Frydenberg
Address 119619 0
18 Physio
322 Glenferrie Road, Malvern VIC 3144
Country 119619 0
Australia
Phone 119619 0
+61 431614281
Fax 119619 0
Email 119619 0
jessfrydenberg@gmail.com
Contact person for scientific queries
Name 119620 0
Jessica Frydenberg
Address 119620 0
18 Physio
322 Glenferrie Road, Malvern VIC 3144
Country 119620 0
Australia
Phone 119620 0
+61 431614281
Fax 119620 0
Email 119620 0
jessfrydenberg@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Despite the anonymous nature of the questionnaire, an individual may be identifiable through the way they answer the questionnaire. Therefore, to maintain participant confidentiality IPD will not be available, particularly given the personal nature of the questions being asked.


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.