Pelvic Floor AwarenessNCT06487923
Knowledge and Awareness of Pelvic Floor Health
An observational study of Pelvic Floor Awareness, run by Atlas University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Floor Awareness
- How many people
- 298 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2024to 28 Jun 2024
- How long will I take part?
- 20 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Primiparous women who have given birth within the past year aged 18 and older
Who may be able to join
- 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
Who cannot join
- Women who have not given birth
- Multiparous women
- Women who had a cesarean delivery
- Having difficulty to understanding evaluations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Pelvic Floor Awareness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Postpartum Women | 298 primiparous women who have given birth vaginally in the last year |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic Floor Health Knowledge Quiz
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.
Measured: Baseline
Carol Postpartum Sexual Function And Dyspareunia Assessment Scale
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.
Measured: Baseline
Sociodemographic Information Form
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.
Measured: Baseline
Secondary outcomes (3)
Nottingham Health Profile
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.
Measured: Baseline
Prolapse and Incontinence Knowledge Questionnaire
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.
Measured: Baseline
Global Pelvic Floor Symptom Bother Questionnaire
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start1 Apr 2024
- Primary completion15 May 2024
- Study completion28 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Floor AwarenessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 298 participants (actual)
- Target duration
- 20 Days
Sponsor and investigators
- Lead sponsor
- Atlas University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06487923
- Sponsor's protocol ID
- E-22686390-050.99-34849
- Status last verified
- Jun 2024
- First submitted
- 28 Jun 2024
- Last updated
- 9 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Knowledge and Awareness of Pelvic Floor Health on Dyspareunia in Postpartum Women
- ClinicalTrials.gov ID
- NCT06487923
- Acronym / sponsor ID
- E-22686390-050.99-34849
- Conditions
- Pelvic Floor Awareness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 298 participants (actual)
- Lead sponsor
- Atlas UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 28 Jun 2024 (actual)
- First posted
- 5 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 20 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Postpartum Women | – | –298 primiparous women who have given birth vaginally in the last year |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Primiparous women who have given birth within the past year aged 18 and older
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Women who have not given birth
- Multiparous women
- Women who had a cesarean delivery
- Having difficulty to understanding evaluations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pelvic Floor Health Knowledge Quiz
Time frame: Baseline
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.
Carol Postpartum Sexual Function And Dyspareunia Assessment Scale
Time frame: Baseline
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.
Sociodemographic Information Form
Time frame: Baseline
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.
3 secondary outcomes
Nottingham Health Profile
Time frame: Baseline
Prolapse and Incontinence Knowledge Questionnaire
Time frame: Baseline
Global Pelvic Floor Symptom Bother Questionnaire
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
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Pelvic Floor Awareness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Floor Awareness, run by Atlas University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic Floor Health Knowledge Quiz (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2024.