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- Klinische proef NCT07833280
Kinesiophobia, Physical Activity, Sleep, and Quality of Life in Women With Chronic Pelvic Pain
The Relationship Between Kinesiophobia and Physical Activity, Sleep Quality, and Quality of Life in Women With Chronic Pelvic Pain
The study will include women who present to the Obstetrics and Gynecology outpatient clinic of Kırşehir Ahi Evran Training and Research Hospital with complaints of pelvic pain and are diagnosed with PCAS after a detailed examination, as well as healthy women. All included women will be administered the Tampa Kinesiophobia Scale (TKS), the International Physical Activity Questionnaire (Short), the Pittsburgh Sleep Quality Questionnaire (PSQI), and the Short Form 36 (p-36). The control group will consist of women who meet the inclusion and exclusion criteria but are not diagnosed with PCAS.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
This study is designed as an observational, controlled, cross-sectional study to investigate the relationship between kinesiophobia, physical activity, sleep quality, and health-related quality of life in women with PCAS compared with healthy women.
Women presenting to the Obstetrics and Gynecology outpatient clinic of Kırşehir Ahi Evran Training and Research Hospital with complaints of pelvic pain will undergo a detailed clinical evaluation by an obstetrician-gynecologist. Participants diagnosed with PCAS following clinical assessment and meeting the eligibility criteria will be included in the PCAS group. The control group will consist of healthy women without a diagnosis of PCAS who meet the study's eligibility criteria.
All participants will be informed about the study objectives and procedures, and written informed consent will be obtained before enrollment. Demographic and relevant clinical characteristics will be recorded using a standardized data collection form.
Participants in both groups will undergo a comprehensive assessment using the following validated questionnaires:
Tampa Scale of Kinesiophobia (TSK): To assess fear of movement and fear of injury or reinjury associated with physical activity.
International Physical Activity Questionnaire-Short Form (IPAQ-SF): To evaluate participants' physical activity levels.
Pittsburgh Sleep Quality Index (PSQI): To assess subjective sleep quality and sleep disturbances.
36-Item Short Form Health Survey (SF-36): To evaluate health-related quality of life across physical and mental health domains.
All questionnaires will be administered during a single assessment session. No therapeutic intervention will be provided as part of the study, and participants will continue to receive routine clinical care as appropriate.
The primary objective is to compare kinesiophobia levels between women with PCAS and healthy controls. Secondary objectives are to compare physical activity levels, sleep quality, and health-related quality of life between the groups and to examine the relationships between kinesiophobia and these variables.
The findings are expected to contribute to a better understanding of the physical and psychosocial factors associated with PCAS and may provide a basis for future rehabilitation strategies addressing movement-related fear, physical inactivity, and reduced quality of life.
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: Esra B. DEMİRDÖĞEN
- Telefoonnummer: 05426961169
- E-mail: esra.bayramoglu@ahievran.edu.tr
Studie Locaties
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Merkez
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Kırşehir, Merkez, Turkije (Türkiye), 40100
- Werving
- Kırşehir Ahi Evran Üniversitesi
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Contact:
- Esra BAYRAMOĞLU DEMİRDÖĞEN
- Telefoonnummer: 05426961169
- E-mail: esra.bayramoglu@ahievran.edu.tr
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
women with chronic pelvic pain
Beschrijving
Inclusion Criteria:
- Being between 18-65 years of age
- Having a diagnosis of Chronic Pelvic Pain
- Having a pain score of 5 or higher on the visual analog scale
- Voluntary participation in the study
Exclusion Criteria:
- Not wanting to continue in the study
- Presence of neurological or orthopedic disease
- Active urinary tract infection or recurrent urinary tract infection (more than 5 recurrent infections in the last 12 months)
- Pregnancy
- History of surgery in the pelvic region
- Learning disability or other cognitive impairments.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: CASE_CONTROL
- Tijdsperspectieven: CROSS_SECTIONAL
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
chronic pelvic pain syndrome
This cohort will consist of women diagnosed with chronic pelvic pain syndrome (CPPS) following a detailed clinical evaluation by an obstetrician-gynecologist at Kırşehir Ahi Evran Training and Research Hospital. Eligible participants will undergo a single assessment using the Tampa Scale of Kinesiophobia (TSK), International Physical Activity Questionnaire-Short Form (IPAQ-SF), Pittsburgh Sleep Quality Index (PSQI), and 36-Item Short Form Health Survey (SF-36) to evaluate kinesiophobia, physical activity, sleep quality, and health-related quality of life, respectively. No study-specific therapeutic intervention will be administered. |
evaluation |
|
Healthy
This cohort will consist of healthy women without a diagnosis of chronic pelvic pain syndrome (CPPS) who meet the study's eligibility criteria. Participants will undergo a single assessment using the Tampa Scale of Kinesiophobia (TSK), International Physical Activity Questionnaire-Short Form (IPAQ-SF), Pittsburgh Sleep Quality Index (PSQI), and 36-Item Short Form Health Survey (SF-36) to evaluate kinesiophobia, physical activity, sleep quality, and health-related quality of life, respectively. No study-specific therapeutic intervention will be administered. |
evaluation |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
kinesiophobia
Tijdsspanne: At baseline (single assessment)
|
Kinesiophobia will be assessed using the Tampa Scale for Kinesiophobia (TSK). The scale consists of 17 items rated on a 4-point Likert scale. The total score ranges from 17 to 68, with higher scores indicating greater levels of kinesiophobia. |
At baseline (single assessment)
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Esra BAYRAMOĞLU DEMİRDÖĞEN, Kırşehir Eğitim ve Araştırma Hastanesi
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Pijn
- Neurologische manifestaties
- Ziekten van het zenuwstelsel
- Psychische aandoening
- Slaap-waakstoornissen
- Slaapstoornissen, intrinsiek
- Dyssomnieën
- Fobische stoornissen
- Angst stoornissen
- Pathologische aandoeningen, tekenen en symptomen
- Tekenen en symptomen
- Kinesiofobie
- Chronische pijn
- Slaapinitiatie en -onderhoudsstoornissen
- Bekkenpijn
- Kwaliteit, toegang en evaluatie van de gezondheidszorg
- Onderzoekstechnieken
- Epidemiologische methoden
- Gegevensverzameling
- Evaluatiemechanismen voor gezondheidszorg
- Kwaliteit van de gezondheidszorg
- Volksgezondheid
- Milieu en volksgezondheid
- Enquêtes en vragenlijsten
Andere studie-ID-nummers
- KAEU-EBAYRAMOGLUD-007
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
privacy of personal information
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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