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临床试验/NCT07253519
NCT07253519尚未招募不适用

The Relationship Between Mood and Insomnia Severity and Caregiver Burden in Caregivers of Stroke Patients

Istanbul Physical Medicine Rehabilitation Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年11月20日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
Zarit Caregiver Burden Scale (ZCBS)

研究概览

简要总结

This study will include stroke patients aged 18-80 years and their caregivers. Demographic data such as age, height, weight, and comorbidities will be recorded, along with stroke-specific characteristics including duration of stroke, affected side, lesion location, and etiology. Patients' functional status will be assessed using the Modified Rankin Scale, Brunnstrom Stages, and the Modified Barthel Index, while ambulation status will be documented with the Holden Scale. Caregivers will complete the Insomnia Severity Index to assess the severity of sleep disturbances and the Hospital Anxiety and Depression Scale to evaluate anxiety and depressive symptoms. Caregiver burden will be measured using the Zarit Caregiver Burden Scale. The study aims to investigate the relationship between caregivers' mood, insomnia severity, and caregiver burden.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age 18-80 years.
  • •Clinical diagnosis of stroke (ischemic or hemorrhagic; first-ever or recurrent).
  • •Ability of both the patient and caregiver to communicate in Turkish and participate in evaluations (mRS, Brunnstrom, Modified Barthel Index, Holden).
  • •Caregiver must have been the primary caregiver for the patient for at least 1 month.
  • •Willingness of both the patient and caregiver to participate in the study.

排除标准

  • •History of subarachnoid hemorrhage.
  • •Inability to communicate effectively due to severe aphasia or severe cognitive impairment.
  • •Terminal illness (life expectancy < 6 months).
  • •Inability to reliably complete questionnaires due to a psychiatric disorder.

结局指标

主要结局

Zarit Caregiver Burden Scale (ZCBS)

时间窗: Baseline

Measures the perceived caregiver burden related to physical, emotional, social, and financial strain. Score Range: 0-88 Higher scores indicate higher caregiver burden.

次要结局

  • Holden Functional Ambulation Classification (FAC)(Baseline)
  • Modified Barthel Index (MBI)(Baseline)
  • Insomnia Severity Index (ISI)(Baseline)
  • Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)(Baseline)
  • Hospital Anxiety and Depression Scale - Depression Subscale (HADS-D)(Baseline)
  • Modified Rankin Scale (mRS)(Baseline)

研究者

发起方
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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