Health TrialsbyHealthPanel

Multiple Sclerosis Severity and Caregiver Health Outcomes

ConditionsMultiple SclerosisCaregiver BurdenSleep QualityPhysical ActivityPsychological Stress
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorSüleyman Korkusuz

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

The study population will consist of 68 adult caregivers of individuals diagnosed with multiple sclerosis who receive care at Başkent University Hospital. Caregivers will be recruited to evaluate the associations between MS severity and caregiver health outcomes.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

68 Participants
are grouped into 1 trial group
Group A: Caregivers of Patients With Multiple Sclerosis

Trial outcomes

Primary outcomes

1

Caregiver Burden (Zarit Burden Interview)

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

Time frame
Baseline

Secondary outcomes

1

Sleep Quality (Pittsburgh Sleep Quality Index)

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.

Time frame
Baseline
2

Physical Activity (IPAQ-SF)

Physical activity will be assessed using the International Physical Activity Questionnaire-Short Form (IPAQ-SF). Total physical activity will be expressed as metabolic equivalent of task minutes per week (MET-min/week) based on activities performed during the previous seven days. Total MET-min/week is calculated as the sum of walking (3.3 METs × minutes × days), moderate-intensity activity (4.0 METs × minutes × days), and vigorous-intensity activity (8.0 METs × minutes × days). The minimum possible value is 0 MET-min/week; there is no fixed maximum score. Higher MET-min/week values indicate a higher level of physical activity and therefore a better outcome.

Time frame
Baseline
3

Body Awareness (Body Awareness Questionnaire)

Body awareness will be assessed using the 18-item Body Awareness Questionnaire (BAQ). Each item is rated on a 7-point Likert scale from 1 to 7, yielding a total score ranging from 18 to 126. Higher scores indicate greater body awareness and therefore a better outcome

Time frame
Baseline
4

Perceived Stress (Perceived Stress Scale)

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.

Time frame
Baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Süleyman Korkusuz

Lead sponsor

Atılım University

Sponsor institution

Source ClinicalTrials.gov

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