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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07253519
Enrollment
100
Registered
2025-11-28
Start date
2025-11-20
Completion date
2025-11-30
Last updated
2025-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Brief summary

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.

Interventions

OTHERno intervention

no intervention

Sponsors

Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
Zarit Caregiver Burden Scale (ZCBS)BaselineMeasures the perceived caregiver burden related to physical, emotional, social, and financial strain. Score Range: 0-88 Higher scores indicate higher caregiver burden.

Secondary

MeasureTime frameDescription
Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A)BaselineEvaluates the presence and severity of anxiety symptoms in caregivers. Score Range: 0-21 Higher scores indicate more severe anxiety.
Hospital Anxiety and Depression Scale - Depression Subscale (HADS-D)BaselineAssesses depressive symptom severity in caregivers. Score Range: 0-21 Higher scores indicate more severe depression.
Insomnia Severity Index (ISI)BaselineAssesses the severity of insomnia symptoms experienced by caregivers. Score Range: 0-28 Higher scores indicate more severe insomnia.
Modified Barthel Index (MBI)BaselineMeasures independence in activities of daily living. Score Range: 0-100 Higher scores indicate greater independence.
Holden Functional Ambulation Classification (FAC)BaselineEvaluates ambulation ability and level of assistance required. Score Range: 0-5 Higher scores indicate more independent walking.
Modified Rankin Scale (mRS)BaselineClinician-rated scale assessing global disability in stroke patients. Score Range: 0-6 Higher scores indicate greater disability.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026