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NCT Number: NCT07253519

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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Istanbul, Turkey (Türkiye)

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

No intervention

Other

no intervention

Primary outcomes

  1. Zarit Caregiver Burden Scale (ZCBS)

    Time frame: Baseline

    Measures the perceived caregiver burden related to physical, emotional, social, and financial strain.

    Score Range: 0-88

    Higher scores indicate higher caregiver burden.

Secondary outcomes

  1. Insomnia Severity Index (ISI)

    Time frame: Baseline

    Assesses the severity of insomnia symptoms experienced by caregivers. Score Range: 0-28

    Higher scores indicate more severe insomnia.

  2. Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)

    Time frame: Baseline

    Evaluates the presence and severity of anxiety symptoms in caregivers. Score Range: 0-21

    Higher scores indicate more severe anxiety.

  3. Hospital Anxiety and Depression Scale - Depression Subscale (HADS-D)

    Time frame: Baseline

    Assesses depressive symptom severity in caregivers. Score Range: 0-21

    Higher scores indicate more severe depression.

  4. Modified Rankin Scale (mRS)

    Time frame: Baseline

    Clinician-rated scale assessing global disability in stroke patients. Score Range: 0-6

    Higher scores indicate greater disability.

  5. Modified Barthel Index (MBI)

    Time frame: Baseline

    Measures independence in activities of daily living. Score Range: 0-100

    Higher scores indicate greater independence.

  6. Holden Functional Ambulation Classification (FAC)

    Time frame: Baseline

    Evaluates ambulation ability and level of assistance required. Score Range: 0-5

    Higher scores indicate more independent walking.

Sponsors and collaborators

Lead sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Nov 28, 2025
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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