Reliability and Validity of the Turkish Version of General Sleep Disturbance Scale (GSDS-T) in Multiple Sclerosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorIstanbul Medeniyet University
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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,
Trial population
Patients with Multiple sclerosis who are aged 18-65 years with EDSS score \> 2 and able to speak and read Turkish.
Trial design
Design model
Other
Time perspective
Cross-sectional
Treatments tested in this trial
Turkish Validity and Reliability of The GSDS-T in patients with multiple sclerosis
Other interventionThe 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.
Treatment groups
126 Participants
are divided into 1 treatment groupGroup A: Patients with MS1 intervention
Trial outcomes
Primary outcomes
1
Sleep disturbances
Sleep disturbances will be assessed with the general sleep disturbance scale (GSDS). It consists of 21 items in total. Each item is scored on a scale of 0-7 includes six sub-categories: Difficulty falling asleep, waking up from sleep; sleep quality; sleep duration; daytime sleepiness; and taking supplements to help sleep. The total score is the calculated sum of 21 items. The minimum score is "0" while the maximum score is "147" points. Higher scores indicate more sleep disturbances.
Time frame
baseline2
Sleep quality
Sleep quality will be assessed with the Pittsburgh Sleep Quality Index (PSQI). The PSQI consists of 24 questions in total. The scale has 7 components: sleep quality (component 1), sleep latency (component 2), sleep duration (component 3), habitual sleep efficiency (component 4), sleep disturbance (component 5), use of sleeping pills (component 6), and daytime sleep dysfunction (component 7). Each component is evaluated on a 0-3 scale. The sum of these 7 component scores gives the total PSQI score. The total PSQI score varies between 0-21. While the sleep quality of individuals with a total score of 5 and below is evaluated as "good," the sleep quality of individuals with a score above 5 is evaluated as "poor."
Time frame
baselineSponsors and contacts
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Source ClinicalTrials.gov