Reliability and Validity of the Turkish Version of General Sleep Disturbance Scale (GSDS-T) in Multiple Sclerosis

NCT ID: NCT06875908

Last Updated: 2025-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

126 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-15

Study Completion Date

2025-08-10

Brief Summary

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The GSDS-T was developed by Lee KA to assess difficulty falling asleep, waking up during sleep, sleep quality, and daytime alertnes. The Turkish validity and reliability of the scale have been conducted on stroke patients but not on multiple sclerosis patients. The aim of this study is to investigate the validity and reliability of the Turkish version of general sleep disturbance scale (GSDS-T) in patients with multiple sclerosis

Detailed Description

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The GSDS-T was developed by Lee KA to assess difficulty falling asleep, waking up during sleep, sleep quality, and daytime alertnes. The Turkish validity and reliability of the scale has been conducted on stroke patients but not on multiple sclerosis patients. The aim of this study is to investigate the validity and reliability of the Turkish version of general sleep disturbance scale (GSDS-T) in patients with multiple sclerosis. GSD has 21 questions. This study will be conducted on patients with multiple sclerosis (MS). 126 participants will be included in the study. In order to evaluate the validity of the GSDS-T, the Pittsburgh Sleep Quality Index (PSQI) which can evaluate sleep quality and has been validated in Turkish, will be used. Scales will be repeated after 15 days to assess test-retest reliability.

Conditions

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Multiple Sclerosis Sleep Disturbance

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patients with MS

Turkish Validity and Reliability of The GSDS-T in patients with multiple sclerosis The aim of this study is to investigate the validity and reliability of the Turkish version of general sleep disturbance scale (GSDS-T) in patients with multiple sclerosis. It has 21 questions. This study will be conducted on patients with multiple sclerosis. In order to evaluate the validity of the GSDS-T, the Pittsburgh Sleep Quality Index (PSQI) which can evaluate sleep quality and has been validated in Turkish, will be used. Scales will be repeated after 15 days to assess test-retest reliability.

Turkish Validity and Reliability of The GSDS-T in patients with multiple sclerosis

Intervention Type OTHER

The aim of this study is to investigate the validity and reliability of the Turkish version of general sleep disturbance scale (GSDS-T) in patients with multiple sclerosis. It has 21 questions. This study will be conducted on patients with multiple sclerosis. In order to evaluate the validity of the GSDS-T, the Pittsburgh Sleep Quality Index (PSQI) which can evaluate sleep quality and has been validated in Turkish, will be used. Scales will be repeated after 15 days to assess test-retest reliability.

Interventions

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Turkish Validity and Reliability of The GSDS-T in patients with multiple sclerosis

The aim of this study is to investigate the validity and reliability of the Turkish version of general sleep disturbance scale (GSDS-T) in patients with multiple sclerosis. It has 21 questions. This study will be conducted on patients with multiple sclerosis. In order to evaluate the validity of the GSDS-T, the Pittsburgh Sleep Quality Index (PSQI) which can evaluate sleep quality and has been validated in Turkish, will be used. Scales will be repeated after 15 days to assess test-retest reliability.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Individuals over the age of 18 who have been diagnosed with Multiple Sclerosis for at least two years,
* Those with an EDSS score \>2.
* Those without symptoms of insomnia according to the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) diagnostic criteria
* Individuals whose native language is Turkish and who have the ability to speak and understand.

Exclusion Criteria

* Those with severe spasticity,
* Those with vision and hearing problems,
* Those with a known mental illness (major depression, schizophrenia, psychosis, etc.),
* Those in an acute relapse phase,
* Those using dietary supplements,
* Those using tranquilizers or immunosuppressants.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Istanbul Medeniyet University

OTHER

Sponsor Role lead

Responsible Party

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Emel Mete

Assistant Professor, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Bağcılar Training and Research Hospital

Bağcılar, Istanbul, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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EMEL METE

Role: CONTACT

+905376096265

Facility Contacts

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EMEL METE

Role: primary

+905376096265

Other Identifiers

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MS-GSDS

Identifier Type: -

Identifier Source: org_study_id

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