About this trial
This study aims to adapt the Sleep Screening Scale for Children and Adolescents with Complex Chronic Conditions (SCAC) into Turkish and test its reliability and validity for this population. Children and adolescents with complex chronic conditions (CCC) often have ongoing and multiple health problems. These children often face a high risk of sleep problems, but there are no screening tools in Turkish designed specifically for them.
The main goal is to confirm that the Turkish version of the SCAC is accurate and reliable. The study will also look at how common different types of sleep problems are in children with CCC, and how these problems are related to factors such as diagnosis, age, sex, and other medical conditions.
Another goal is to compare children's sleep at home with their sleep during a stay in the pediatric intensive care unit (PICU). The study will also examine how environmental factors (such as light and noise) and medical factors (such as pain, medications, and devices) affect sleep in the hospital. After discharge, sleep recovery will be followed for up to 3 months using sleep diaries and actigraphy (a wearable device that measures movement during sleep).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
Children aged 1 months-18 years with at least one complex chronic condition (defined by the 2014 CCC classification)
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Psychometric validation of the Turkish version of the Sleep Screening Scale for Children and Adolescents with Complex Chronic Conditions (SCAC)
Description: The primary outcome is the psychometric validation of the Sleep Screening Scale for Children and Adolescents with Complex Chronic Conditions (SCAC), originally developed by Larissa Alice Kubek and adapted into Turkish (Kronik Karmaşık Durumu Olan Çocuklar ve Ergenler İçin Uyku Tarama Anketi; KUBA) through forward-backward translation. The scale consists of 29 items grouped into four factors based on the International Classification of Sleep Disorders - Third Edition (ICSD-3) diagnostic categories: Sleep initiation and maintenance (7 items) Sleep-related breathing and arousals (9 items) Daytime sleepiness (7 items) Sleep-related movements (6 items) Each item is rated for the frequency of symptoms in the past 7 days, with higher scores indicating a greater presence of sleep-related problems. The total score ranges from 0 to 203, and subscale scores range from 0 to 63 depending on the number of items in each factor. Internal consistency will be assessed using Cronbach's
Test-retest reliability of the Turkish version of the SCAC
Test-retest reliability will be assessed in a subgroup of participants by re-administering the SCAC at least four weeks after discharge from the pediatric intensive care unit (PICU). Reliability will be calculated using intraclass correlation coefficients (ICCs) for the total and subscale scores
Prevalence and subtype distribution of sleep disturbances in children with Complex Chronic Conditions (CCC)
Sleep disturbances will be assessed using the SCAC Scale. The questionnaire has 29 items; each item is rated for frequency of occurrence in the past 7 days (0 = never, 7 = every day). Four subscale scores are calculated based on the SCAC domains: (1) Sleep initiation and maintenance (7 items, score range 0-49), (2) Sleep-related breathing and arousals (9 items, score range 0-63), (3) Daytime sleepiness (7 items, score range 0-49), and (4) Sleep-related movements (6 items, score range 0-42). The total score ranges from 0 to 203, with higher scores indicating greater presence of sleep-related problems.
Secondary outcomes
Objective sleep parameters during PICU stay
Objective sleep will be assessed using wrist actigraphy, placed on Day 1 of PICU admission in participants for whom actigraphy is feasible, and corroborated with sleep diaries and nursing observation logs. The primary reported metric will be sleep efficiency, calculated as total sleep time ÷ total sleep opportunity × 100% per night and averaged across the PICU stay. Higher percentages indicate better sleep efficiency. Additional exploratory parameters (total sleep time, number of awakenings, longest uninterrupted sleep period) will be collected to characterize sleep patterns and for quality checks, but not as separate outcome measures.
Correlation of environmental and clinical factors with sleep efficiency (actigraphy and sleep diaries)
The primary outcome will be sleep efficiency measured using actigraphy and daily sleep diaries. Sleep efficiency will be calculated as: total sleep time ÷ total sleep opportunity × 100%, and averaged across the PICU stay. Correlation analyses will be conducted between sleep efficiency and: Light exposure (lux; actigraphy ambient light channel), Sound exposure (dB; bedside calibrated sound level meter), Nighttime nursing interventions (nursing observation logs), Pain (Face, Legs, Activity, Cry, Consolability scale, (0-10) ; Numeric Rating Scale (0-10)) Disease severity (Pediatric Logistic Organ Dysfunction-2 daily score) Medication exposure (yes/no, for sedatives, and related medications). Exploratory sleep parameters will also be derived from actigraphy and diaries, including: Total sleep time (minutes/night), Number of awakenings (count/night), Longest uninterrupted sleep period (minutes/night). These will be reported for descriptive analyses but not as separate outcome measures
Comparison of home and hospital sleep patterns
Sleep patterns will be assessed with the SCAC in Complex chronic conditions. Parents will report the home baseline sleep over the previous 7 days before admission, and the SCAC will be administered in the PICU on Day 7 of admission or at discharge whichever comes first. The outcome will be the change in SCAC scores. SCAC total scores range from 0-203; higher scores indicate greater sleep-related problems.
Change in SCAC Scores From Hospitalization to 3 Months Post-Discharge
Sleep problems will be assessed with the SCAC after discharge. SCAC will be administered at Day 15, Month 1, Month 2, and Month 3 post-discharge. The primary reported value is the change in SCAC scores from hospitalization to Month 3. SCAC total score range: 0-203; higher scores indicate worse sleep-related problems.
Sponsors and contacts
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Marmara University
Lead sponsor
Başakşehir Çam & Sakura City Hospital
Collaborator