Pregnancy-Related Pelvic Girdle PainNCT05990361
Sexual Function, Body Image, Kinesiophobia and Physical Activity in Pregnant Women
An observational study of Pregnancy-Related Pelvic Girdle Pain, run by Muş Alparslan University at 1 site in Turkey (Türkiye).
Trial summary
This study compares sexual function, body image, kinesiophobia and physical activity level in women with and without pregnancy-related pelvic girdle pain. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Pregnancy-Related Pelvic Girdle Pain
- What is being tested?
- clinical diagnostic test
- How many people
- 125 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Apr 2023to 30 Aug 2023
- 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 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Women with and without pregnancy-related pelvic girdle pain
Who may be able to join
- Being between 18 and 40 years-old,
- Being second or third trimester of pregnancy
- Being literate in Turkish
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Sexual Function, Body Image, Kinesiophobia and Physical Activity Level in Women With and Without Pregnancy-related Pelvic Girdle Pain''
This study compares sexual function, body image, kinesiophobia and physical activity level in women with and without pregnancy-related pelvic girdle pain.
Read the 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.
- Conditions
- Pregnancy-Related Pelvic Girdle Pain
- Being tested
- clinical diagnostic test
- Keywords
- pelvic girdle pain, sexual function, body image, fear of movement
- Medical subject headings
- Pelvic Girdle Pain, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinical diagnostic testDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: clinical diagnostic test | |
| 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. Receives: Diagnostic Test: clinical diagnostic test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy Sexual Response Inventory-Turkish version
to assess sexual functions in pregnant women with and without PGP
Measured: immediately before the clinical diagnostic tests will be applied the questionnaire
Body Image in Pregnancy Scale (BIPS-Turkish)
to evaluate body image perceptions of Turkish pregnant women with and without PGP
Measured: immediately before the clinical diagnostic tests will be applied the questionnaire
Tampa Scale for Kinesiophobia-Turkish version
to evaluate level of kinesiophobia of Turkish pregnant women with and without PGP
Measured: immediately before the clinical diagnostic tests will be applied the questionnaire
Pregnancy Physical Activity Questionnaire-Turkish version
To evaluate the physical activity level of pregnant women with and without PGP
Measured: immediately before the clinical diagnostic tests will be applied the questionnaire
Secondary outcomes (1)
Pelvic Girdle Questionnaire Pelvic Girdle Questionnaire-Turkish version
To evaluate both disability and symptoms women with pregnancy-related PGP
Measured: immediately after the clinical diagnostic tests for PGP will be applied the questionnaire
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start24 Apr 2023
- Primary completion30 Jul 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnancy-Related Pelvic Girdle PainStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muş Alparslan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- SEMİHA YENİŞEHİR, Principal investigator, Muş Alparslan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05990361
- Sponsor's protocol ID
- 18.04.2023-90204
- Status last verified
- Nov 2023
- First submitted
- 9 May 2023
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yenisehir S, Karakaya IC, Ozbey G. Sexual Function of Women with and without Pregnancy-Related Pelvic Girdle Pain and its Relationship with Physical Activity, Kinesiophobia and Body Image: A Cross-Sectional Comparative Study. Reprod Sci. 2024 Oct;31(10):3122-3131. doi: 10.1007/s43032-024-01644-2. Epub 2024 Jul 9.
PubMed 38981994
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Sexual Function, Body Image, Kinesiophobia and Physical Activity Level in Women With and Without Pregnancy-related Pelvic Girdle Pain''
- ClinicalTrials.gov ID
- NCT05990361
- Acronym / sponsor ID
- 18.04.2023-90204
- Conditions
- Pregnancy-Related Pelvic Girdle Pain
- Keywords
- pelvic girdle pain, sexual function, body image, fear of movement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Muş Alparslan UniversityUniversity, hospital or other
- Study start
- 24 Apr 2023 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 14 Aug 2023 (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.
This study compares sexual function, body image, kinesiophobia and physical activity level in women with and without pregnancy-related pelvic girdle pain.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| women with pelvic girdle pain | – | Diagnostic Test: clinical diagnostic testThe 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. |
| women without pelvic girdle pain | – | Diagnostic Test: clinical diagnostic testThe 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women with and without pregnancy-related pelvic girdle pain
Key inclusion criteria (3 listed)
- Being between 18 and 40 years-old,
- Being second or third trimester of pregnancy
- Being literate in Turkish
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clinical diagnostic testThe 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. | Diagnostic test | women with pelvic girdle pain, women without pelvic girdle pain |
Primary outcome
Pregnancy Sexual Response Inventory-Turkish version
Time frame: immediately before the clinical diagnostic tests will be applied the questionnaire
to assess sexual functions in pregnant women with and without PGP
Body Image in Pregnancy Scale (BIPS-Turkish)
Time frame: immediately before the clinical diagnostic tests will be applied the questionnaire
to evaluate body image perceptions of Turkish pregnant women with and without PGP
Tampa Scale for Kinesiophobia-Turkish version
Time frame: immediately before the clinical diagnostic tests will be applied the questionnaire
to evaluate level of kinesiophobia of Turkish pregnant women with and without PGP
Pregnancy Physical Activity Questionnaire-Turkish version
Time frame: immediately before the clinical diagnostic tests will be applied the questionnaire
To evaluate the physical activity level of pregnant women with and without PGP
1 secondary outcome
Pelvic Girdle Questionnaire Pelvic Girdle Questionnaire-Turkish version
Time frame: immediately after the clinical diagnostic tests for PGP will be applied the questionnaire
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 28 Nov 2023.
- Derived from this study: PubMed 38981994Yenisehir S, Karakaya IC, Ozbey G. Sexual Function of Women with and without Pregnancy-Related Pelvic Girdle Pain and its Relationship with Physical Activity, Kinesiophobia and Body Image: A Cross-Sectional Comparative Study. Reprod Sci. 2024 Oct;31(10):3122-3131. doi: 10.1007/s43032-024-01644-2. Epub 2024 Jul 9.
- Individual participant dataSharing planned: No
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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.
SEMİHA YENİŞEHİR principal investigator
Muş Alparslan University
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 Pregnancy-Related Pelvic Girdle Pain, run by Muş Alparslan 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 3 inclusion and 5 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 28 Nov 2023. 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?
Pregnancy Sexual Response Inventory-Turkish version (time frame: immediately before the clinical diagnostic tests will be applied the questionnaire). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05990361, which also lists 1 linked publication.
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 28 Nov 2023.