- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05990361
Sexual Function, Body Image, Kinesiophobia and Physical Activity in Pregnant Women
Comparison of Sexual Function, Body Image, Kinesiophobia and Physical Activity Level in Women With and Without Pregnancy-related Pelvic Girdle Pain''
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Pelvic girdle pain (PGP) is a condition felt around the posterior iliac crystals, gluteal region and the sacroiliac joints, may spread to the back of the thigh, and may occur together or separately with pain in the symphysis pubis. Pregnancy-related PGP causes problems in the sexual life of women. Body image differs with the development of physical symptoms and changes in body size and shape during pregnancy. Body dissatisfaction resulting from physical changes can cause problems in women's attitudes towards sexuality. Sexual function is affected by physiological, anatomical and psychological changes that occur during pregnancy. Sexual function during pregnancy has been associated with conditions such as body image, physical activity level, and pain.
In the literature, there are studies evaluating the relationship between sexual function and body image in pregnant women and in different populations. However, in these studies, questionnaires specific to pregnant women were not used to evaluate sexual function and body image, and a comparison of these parameters was not investigate in women with and without pregnancy-related PGP.
Therefore, this study was planned to compare sexual function, body image, kinesiophobia and physical activity levels in women with and without pregnancy-related PGP.
The outcome measures are Pregnancy Sexual Response Inventory (PSRI), Body Image in Pregnancy Scale (BIPS-Turkish), Tampa Kinesiophobia Scale (TKS) and Pregnancy physical activity questionnaire (PPAQ).
The clinical diagnosis tests are Active Straight Leg Rise, Posterior Pelvic Pain Provocation Test, Long Dorsal Sacroiliac Ligament Palpation, Pelvic Compression, Pelvic Distraction, Patrick-Faber Test and Gaenslen Test.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Muş, Turkey, 49000
- Semiha Yenişehir
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Being between 18 and 40 years-old,
- Being second or third trimester of pregnancy
- Being literate in Turkish
Exclusion Criteria:
- Having a pregnancy complication (preeclampsia, pregnancy-induced hypertension, diabetes, etc.),
- Having a known gynecological or urological problem that may mimic PGP
- Having neurological (multiple sclerosis, spinal cord injury, etc.), orthopedic (hip dislocation, etc.), cardiopulmonary (heart failure, chronic obstructive pulmonary disease, etc.) problems that affect sexual function and physical activity,
- Having situations in which sexual activity is contraindicated and should be restricted (placenta previa, risk of premature birth, cervical insufficiency, antepartum hemorrhage, premature rupture of membranes, genital infection, etc.),
- Having visual, auditory and cognitive problems that may prevent participation in the study.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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women with pelvic girdle pain
The subjects who have at least one positive result from Active Straight Leg Raise, and Posterior Pelvic Pain Provocation Tests; and at least two positive results from the Pelvic Compression and Distraction, Patrick Faber, Gaenslen and Long Dorsal Sacroiliac Ligament Palpation tests are classified as with PGP group.
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The clinical diagnosis tests are Active Straight Leg Rise ASLR, Posterior Pelvic Pain Provocation, Long Dorsal Sacroiliac Ligament Palpation (LDSLP), Pelvic Compression, Pelvic Distraction, Patrick-Faber Test (PF), and Gaenslen Test (GT). The subjects who had at least one positive result from ASLR and P4 Tests; and at least two positive results from the Pelvic Compression and Distraction, PF, GT and LDSLP tests are classified as with PGP group. |
|
women without pelvic girdle pain
The subjects who have not at least one positive result from Active Straight Leg Raise, and Posterior Pelvic Pain Provocation Tests; and at least two positive results from the Pelvic Compression and Distraction, Patrick Faber, Gaenslen and Long Dorsal Sacroiliac Ligament Palpation tests are classified as without PGP group.
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The clinical diagnosis tests are Active Straight Leg Rise ASLR, Posterior Pelvic Pain Provocation, Long Dorsal Sacroiliac Ligament Palpation (LDSLP), Pelvic Compression, Pelvic Distraction, Patrick-Faber Test (PF), and Gaenslen Test (GT). The subjects who had at least one positive result from ASLR and P4 Tests; and at least two positive results from the Pelvic Compression and Distraction, PF, GT and LDSLP tests are classified as with PGP group. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pregnancy Sexual Response Inventory-Turkish version
Time Frame: immediately before the clinical diagnostic tests will be applied the questionnaire
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to assess sexual functions in pregnant women with and without PGP
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immediately before the clinical diagnostic tests will be applied the questionnaire
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Body Image in Pregnancy Scale (BIPS-Turkish)
Time Frame: immediately before the clinical diagnostic tests will be applied the questionnaire
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to evaluate body image perceptions of Turkish pregnant women with and without PGP
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immediately before the clinical diagnostic tests will be applied the questionnaire
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Tampa Scale for Kinesiophobia-Turkish version
Time Frame: immediately before the clinical diagnostic tests will be applied the questionnaire
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to evaluate level of kinesiophobia of Turkish pregnant women with and without PGP
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immediately before the clinical diagnostic tests will be applied the questionnaire
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Pregnancy Physical Activity Questionnaire-Turkish version
Time Frame: immediately before the clinical diagnostic tests will be applied the questionnaire
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To evaluate the physical activity level of pregnant women with and without PGP
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immediately before the clinical diagnostic tests will be applied the questionnaire
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pelvic Girdle Questionnaire Pelvic Girdle Questionnaire-Turkish version
Time Frame: immediately after the clinical diagnostic tests for PGP will be applied the questionnaire
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To evaluate both disability and symptoms women with pregnancy-related PGP
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immediately after the clinical diagnostic tests for PGP will be applied the questionnaire
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: SEMİHA YENİŞEHİR, Muş Alparslan University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18.04.2023-90204
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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-
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