- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Esra B. DEMİRDÖĞEN
- Numero di telefono: 05426961169
- Email: esra.bayramoglu@ahievran.edu.tr
Luoghi di studio
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Merkez
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Kırşehir, Merkez, Turchia (Türkiye), 40100
- Reclutamento
- Kırşehir Ahi Evran Üniversitesi
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Contatto:
- Esra BAYRAMOĞLU DEMİRDÖĞEN
- Numero di telefono: 05426961169
- Email: esra.bayramoglu@ahievran.edu.tr
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
women with chronic pelvic pain
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: CASE_CONTROL
- Prospettive temporali: CROSS_SECTIONAL
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
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 |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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kinesiophobia
Lasso di tempo: At baseline (single assessment)
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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)
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Collaboratori e investigatori
Investigatori
- Investigatore principale: Esra BAYRAMOĞLU DEMİRDÖĞEN, Kırşehir Eğitim ve Araştırma Hastanesi
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Dolore
- Manifestazioni neurologiche
- Malattie del sistema nervoso
- Disordini mentali
- Disturbi del sonno e della veglia
- Disturbi del sonno, intrinseci
- Dissonnie
- Disturbi fobici
- Disturbi d'ansia
- Condizioni patologiche, segni e sintomi
- Segni e sintomi
- Kinesiofobia
- Dolore cronico
- Disturbi dell'inizio e del mantenimento del sonno
- Dolore pelvico
- Qualità, accesso e valutazione dell'assistenza sanitaria
- Tecniche investigative
- Metodi epidemiologici
- Raccolta dei dati
- Meccanismi di valutazione dell'assistenza sanitaria
- Qualità dell'assistenza sanitaria
- Sanità pubblica
- Ambiente e salute pubblica
- Sondaggi e questionari
Altri numeri di identificazione dello studio
- KAEU-EBAYRAMOGLUD-007
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
privacy of personal information
Informazioni su farmaci e dispositivi, documenti di studio
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