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RecruitingNCT07549048Updated Apr 23, 2026

Caregiver Burden in Caregivers of Patients With Multiple Sclerosis

An observational study in Multiple Sclerosis, sponsored by Istanbul Physical Medicine Rehabilitation Training and Research Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-04-23.

Sponsored by Istanbul Physical Medicine Rehabilitation Training and Research Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
50
Ages
18 Years to 80 Years
Sex
All
01

Study summary

Individuals aged 18-80 years who have been clinically diagnosed with multiple sclerosis and their caregivers will be included in the study.

Demographic data of the patients, including age, height, weight, and comorbidities, will be recorded. Disease-specific characteristics such as disease duration, presence of incontinence, ambulation status, and presence and severity of pain will be assessed. Functional status of the patients will be evaluated using the Expanded Disability Status Scale (EDSS) and the Multiple Sclerosis Impact Scale (MSIS). Symptoms related to depression and anxiety in patients will be assessed using the Hospital Anxiety and Depression Scale (HADS).

Subsequently, caregivers of the patients will be evaluated. The severity of insomnia will be assessed using the Insomnia Severity Index (ISI). Symptoms related to anxiety and depression will be evaluated using the Hospital Anxiety and Depression Scale (HADS). Caregiver burden will be assessed using the Zarit Caregiver Burden Scale.

02

Conditions studied

  • Multiple Sclerosis

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03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

Multiple sclerosis and caregivers

Inclusion criteria

  • Age 18-80 years
  • Clinically diagnosed with multiple sclerosis by a neurologist
  • Being followed in the physical therapy and rehabilitation clinics during the study period
  • Having a primary or regular caregiver (family member)
  • Both patient and caregiver able to read and understand Turkish and complete questionnaires
  • Willing to participate and provide written informed consent

Exclusion criteria

Exclusion Criteria:

  • Severe cognitive impairment or communication problems preventing questionnaire completion
  • Acute relapse or hospitalization due to exacerbation within the last month
  • Severe comorbid neurological, psychiatric, or systemic disease affecting assessments
  • Caregiver \<18 years old or not providing regular care
  • Paid professional caregiver
  • Caregiver with severe psychiatric, neurological, or primary sleep disorder
  • Refusal to participate
04

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
50 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes

Interventions

  • OtherNo intervention

    No intervention

05

What researchers measure

Primary outcomes

  1. Zarit Caregiver Burden Scale (Zarit Burden Interview, ZBI)

    Caregiver burden will be assessed using the Zarit Caregiver Burden Scale. Higher scores indicate greater caregiver burden.

    Time frame: Baseline

Secondary outcomes

  1. Insomnia Severity Index (ISI)

    The ISI evaluates the severity of insomnia symptoms. Total scores range from 0 to 28, with higher scores indicating more severe insomnia.

    Time frame: Baseline

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

    Scores range from 0 to 21, with higher scores indicating greater anxiety.

    Time frame: Baseline

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

    Scores range from 0 to 21, with higher scores indicating greater depressive symptoms.

    Time frame: Baseline

  4. Expanded Disability Status Scale (EDSS)

    The EDSS evaluates disability in multiple sclerosis patients, ranging from 0 (normal neurological exam) to 10 (death due to MS).

    Time frame: Baseline

  5. Multiple Sclerosis Impact Scale (MSIS)

    The MSIS assesses the physical and psychological impact of multiple sclerosis on daily life. Higher scores indicate greater impact.

    Time frame: Baseline

06

Study locations

1 of 1 sites recruiting
  • Istanbul Physical Medicine and Rehabilitation Trainig and Research Hospital
    Istanbul, Bahcelievler 34100, Turkey (Türkiye)
    • Büşra Ş Ahısha · Contact · bsrn080@gmail.com · +902124965000
    • · Contact · (0212) 856 27 40
    Recruiting
07

Registry details

Key details

Study ID
NCT07549048
Lead sponsor
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Responsible party
Fatma Nur Kesiktaş (Principal Investigator, Istanbul Physical Medicine Rehabilitation Training and Research Hospital) — Principal investigator
First posted
Apr 23, 2026
Start date
Apr 20, 2026 (estimated)
Primary completion
May 20, 2026 (estimated)
Completion
May 20, 2026 (estimated)
Last update
Apr 23, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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