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NCT Number: NCT07842744

Multiple Sclerosis Severity and Caregiver Health Outcomes

This cross-sectional observational study aims to investigate the associations between multiple sclerosis (MS) severity and caregivers' sleep quality, physical activity, body awareness, perceived stress, and caregiver burden. A total of 68 caregivers of patients with MS will be recruited from Başkent University Hospital. MS severity will be assessed using the Expanded Disability Status Scale (EDSS), while caregiver health outcomes will be evaluated using validated questionnaires. The findings are expected to provide insight into the multidimensional impact of MS severity on caregiver health and well-being.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Behavior Behavioral Symptoms Caregiver Burden Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Dyssomnias Immune System Diseases Mental Disorders Motor Activity Nervous System Diseases Physical Activity Psychological Stress Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Quality Sleep Wake Disorders Stress, Psychological

Sex eligibility

All sexes

Study type

Observational

Primary location

Atılım University

Ankara, Turkey (Türkiye)

About this study

This cross-sectional observational study aims to investigate the associations between multiple sclerosis (MS) severity and caregivers' sleep quality, physical activity, body awareness, perceived stress, and caregiver burden.

A total of 68 caregivers of individuals with MS will be included. Disease severity will be assessed using the Expanded Disability Status Scale (EDSS). Caregiver outcomes will be evaluated using the Pittsburgh Sleep Quality Index (PSQI), International Physical Activity Questionnaire-Short Form (IPAQ-SF), Body Awareness Questionnaire (BAQ), Perceived Stress Scale (PSS), and Zarit Burden Interview (ZBI).

The study will examine the relationships between MS severity and caregiver health outcomes within the framework of the International Classification of Functioning, Disability and Health (ICF). No therapeutic intervention will be administered.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Being 18 years of age or older.
  • Providing regular care to an individual diagnosed with multiple sclerosis for at least six months.
  • Volunteering to participate in the study.

Exclusion criteria

  • Having a cognitive impairment that prevents completion of the assessments.
  • Having a severe physical or psychiatric condition that may interfere with study assessments.
  • Being unable to complete the questionnaires.

Treatment and study plan

Primary outcomes

  1. Caregiver Burden (Zarit Burden Interview)

    Time frame: Baseline

    Caregiver burden will be assessed using the Zarit Burden Interview (ZBI). Higher scores indicate greater perceived caregiver burden.

Secondary outcomes

  1. Sleep Quality (Pittsburgh Sleep Quality Index)

    Time frame: Baseline

    Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). Total scores range from 0 to 21, with higher scores indicating poorer sleep quality. Scores above 5 indicate poor sleep quality.

  2. Physical Activity (IPAQ-SF)

    Time frame: Baseline

    Physical activity will be assessed using the International Physical Activity Questionnaire-Short Form (IPAQ-SF). Total physical activity will be expressed in MET-minutes per week based on activities performed during the previous seven days.

  3. Body Awareness (Body Awareness Questionnaire)

    Time frame: Baseline

    Body awareness will be assessed using the 18-item Body Awareness Questionnaire (BAQ). Higher scores indicate greater awareness of internal bodily sensations.

  4. Perceived Stress (Perceived Stress Scale)

    Time frame: Baseline

    Perceived stress will be assessed using the 10-item Perceived Stress Scale (PSS-10). Total scores range from 0 to 40, with higher scores indicating greater perceived stress.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Süleyman Korkusuz

Other

Registry information

Official study title

Associations Between Multiple Sclerosis Severity and Caregivers' Sleep Quality, Physical Activity, Body Awareness, Psychosocial Status, and Caregiver Burden: An ICF-Based Cross-Sectional Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 25, 2026
Registry last updated
Sep 25, 2026

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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