- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Esra B. DEMİRDÖĞEN
- 전화번호: 05426961169
- 이메일: esra.bayramoglu@ahievran.edu.tr
연구 장소
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Merkez
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Kırşehir, Merkez, 터키 (Türkiye), 40100
- 모병
- Kırşehir Ahi Evran Üniversitesi
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연락하다:
- Esra BAYRAMOĞLU DEMİRDÖĞEN
- 전화번호: 05426961169
- 이메일: esra.bayramoglu@ahievran.edu.tr
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-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
women with chronic pelvic pain
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: CASE_CONTROL
- 시간 관점: CROSS_SECTIONAL
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
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 |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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kinesiophobia
기간: 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)
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Esra BAYRAMOĞLU DEMİRDÖĞEN, Kırşehir Eğitim ve Araştırma Hastanesi
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- KAEU-EBAYRAMOGLUD-007
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
privacy of personal information
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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