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

ConditionStroke
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorIstanbul Physical Medicine Rehabilitation Training and Research Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

stroke

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

  • no intervention

    Other intervention

    no intervention

Treatment groups

No treatment groups listed

Trial outcomes

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.

Time frame
Baseline

Secondary outcomes

1

Insomnia Severity Index (ISI)

Assesses the severity of insomnia symptoms experienced by caregivers. Score Range: 0-28 Higher scores indicate more severe insomnia.

Time frame
Baseline
2

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

Evaluates the presence and severity of anxiety symptoms in caregivers. Score Range: 0-21 Higher scores indicate more severe anxiety.

Time frame
Baseline
3

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

Assesses depressive symptom severity in caregivers. Score Range: 0-21 Higher scores indicate more severe depression.

Time frame
Baseline
4

Modified Rankin Scale (mRS)

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

Time frame
Baseline

Other outcomes

Sponsors and contacts

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