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

NCT07253519 | Not Yet Recruiting

• 1 other identifier: istftrrrr
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Zarit Caregiver Burden Scale (ZCBS)

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

  Baseline

Secondary Outcomes (6)

• 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

• Modified Barthel Index (MBI)

  Baseline

Interventions

no intervention OTHER

no intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

stroke

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul Physical Medicine Rehabilitation Training and Research Hospital: lead

Study Sites (1)

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: November 28, 2025
• Study Start: November 20, 2025
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: November 28, 2025

Record last verified: 2025-11

Locations

TU (1)