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Kinesiophobia, Physical Activity, Sleep, and Quality of Life in Women With Chronic Pelvic Pain

2026年9月21日 更新者:Esra BAYRAMOĞLU DEMİRDÖĞEN、Ahi Evran University Education and Research Hospital

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.

研究概览

地位

招聘中

详细说明

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.

研究类型

观察性的

注册 (估计的)

120

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 65年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

女性

取样方法

非概率样本

研究人群

women with chronic pelvic pain

描述

Inclusion Criteria:

  1. Being between 18-65 years of age
  2. Having a diagnosis of Chronic Pelvic Pain
  3. Having a pain score of 5 or higher on the visual analog scale
  4. Voluntary participation in the study

Exclusion Criteria:

  1. Not wanting to continue in the study
  2. Presence of neurological or orthopedic disease
  3. Active urinary tract infection or recurrent urinary tract infection (more than 5 recurrent infections in the last 12 months)
  4. Pregnancy
  5. History of surgery in the pelvic region
  6. Learning disability or other cognitive impairments.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:CASE_CONTROL
  • 时间观点:CROSS_SECTIONAL

队列和干预

团体/队列
干预/治疗
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

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
kinesiophobia
大体时间: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)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Esra BAYRAMOĞLU DEMİRDÖĞEN、Kırşehir Eğitim ve Araştırma Hastanesi

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年2月1日

初级完成 (估计的)

2026年10月10日

研究完成 (估计的)

2026年10月15日

研究注册日期

首次提交

2026年8月9日

首先提交符合 QC 标准的

2026年9月21日

首次发布 (实际的)

2026年9月22日

研究记录更新

最后更新发布 (实际的)

2026年9月22日

上次提交的符合 QC 标准的更新

2026年9月21日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

privacy of personal information

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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