- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06487923
Knowledge and Awareness of Pelvic Floor Health (In Postpartum)
July 5, 2024 updated by: Atlas University
The Effects of Knowledge and Awareness of Pelvic Floor Health on Dyspareunia in Postpartum Women
The aim of this study is to investigate the relationship between knowledge and awareness of pelvic floor health and dyspareunia, pelvic floor dysfunctions, and quality of life in postpartum women.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
298
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Istanbul, Turkey
- Istanbul Atlas University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Primiparous women who have given birth within the past year aged 18 and older
Description
Inclusion Criteria:
- Being a native speaker of Turkish
- Being in the first year of postpartum
- Women who had a vaginal delivery
- Primiparous women
- Women aged 18 and over
Exclusion Criteria:
- Women who have not given birth
- Multiparous women
- Women who had a cesarean delivery
- Having difficulty to understanding evaluations
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Postpartum Women
298 primiparous women who have given birth vaginally in the last year
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pelvic Floor Health Knowledge Quiz
Time Frame: Baseline
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This scale is a self-report tool developed to measure pelvic floor knowledge and awareness.The scale was developed by Wala'a Al-Deges in 2019.
The original version is in Turkish.
It consists of 29 questions divided into 3 sub-parameters.
A high score indicates a high level of awareness.
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Baseline
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Carol Postpartum Sexual Function And Dyspareunia Assessment Scale
Time Frame: Baseline
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This scale is a self-report tool developed to evaluate sexual functions and dyspareunia who have resumed vaginal intercourse after vaginal delivery.
It developed by Pérez-García, Solís-Muñoz.
Turkish Validity and reliability study was conducted by Evili.
The scale consists of 11 items and 4 subparameters in a Likert-type format.
Except for 'preparation for sexual activity', a high score indicates a high level of dysfunction.
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Baseline
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Sociodemographic Information Form
Time Frame: Baseline
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The demographic information form consisted of 27 questions to determine and classify individuals' socio-demographic characteristics, including descriptive features such as age, height, weight, BMI, marital status, recorded using this form.
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Baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Nottingham Health Profile
Time Frame: Baseline
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This scale assesses individuals' well-being in physical, emotional, and social domains.
It Developed by Hunt in 1981.
Turkish Validity and reliability study was conducted by Kucukdeveci in 2000.
The scale consists of 38 items and 6 subparameters.
A high score indicates a low quality of life.
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Baseline
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Prolapse and Incontinence Knowledge Questionnaire
Time Frame: Baseline
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To assess individuals' knowledge levels about prolapse and incontinence, the Prolapse and Incontinence Knowledge Questionnaire was used.
Validity and reliability studies of the questionnaire were conducted by Celenay in 2019.
The questionnaire consists of a total of 24 statements, with 12 statements related to Pelvic Organ Prolapse and 12 statements related to Urinary Incontinence.
Correct responses contribute to the total score, which ranges from a minimum of 0 to a maximum of 12.
A higher score indicates greater knowledge about incontinence and prolapse.
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Baseline
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Global Pelvic Floor Symptom Bother Questionnaire
Time Frame: Baseline
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The Global Pelvic Floor Dysfunction Inventory is used to assess whether individuals have any pelvic floor dysfunctions such as urinary urgency and frequency, difficulty emptying the bladder, pelvic organ prolapse, difficulty with defecation, fecal incontinence, sexual dysfunction, and to evaluate the degree of discomfort caused by these conditions if present.
Validity and reliability study in Turkish women was conducted by Dogan in 2015.
It consists of 9 questions.
The total score from the questionnaire ranges from 0 to 45, with a higher score indicating a higher degree of discomfort.
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Baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2024
Primary Completion (Actual)
May 15, 2024
Study Completion (Actual)
June 28, 2024
Study Registration Dates
First Submitted
June 28, 2024
First Submitted That Met QC Criteria
June 28, 2024
First Posted (Actual)
July 5, 2024
Study Record Updates
Last Update Posted (Actual)
July 9, 2024
Last Update Submitted That Met QC Criteria
July 5, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- E-22686390-050.99-34849
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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