Turkish Adaptation of a Sleep Screening Tool for Pediatric Complex Chronic Conditions

Not yet recruiting

• Conditions: Chronic Conditions; Pediatric Intensive Care; Sleep Disorder (Disorder); Sleep

• Registration Number: NCT07210476
• Lead Sponsor: Marmara University

Brief Summary

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).

Detailed Description

This multi-phase, prospective observational study is designed to evaluate sleep disturbances among children with complex chronic conditions (CCCs), focusing on both the hospital period-specifically pediatric intensive care units (PICUs)-and the post-discharge transition to home. The study incorporates both subjective (questionnaire-based) and objective (actigraphy-based) assessments and integrates a family-centered, developmentally appropriate, and biopsychosocial framework.

The first phase involves the cross-cultural adaptation and psychometric validation of the "Sleep Screening Tool for Children and Adolescents with Complex Chronic Conditions (SCAC)" into Turkish. This includes forward and backward translation, expert panel review, cognitive interviews with caregivers, and a pilot study. Validity (via exploratory factor analysis using principal components analysis with varimax rotation) and internal consistency (via Cronbach's alpha) will be tested. Test-retest reliability will be evaluated by re-administering the scale one month after discharge to 50 participants.

In the second phase, children admitted to one of the largest tertiary PICU in Türkiye will be recruited. During hospitalization, sleep-wake patterns will be continuously monitored using actigraphy, while environmental factors including noise and light exposure will be recorded using calibrated sensors placed at the bedside. Nurses will assist with administering tools and maintaining logs. Additional clinical variables such as medications, nighttime interventions, pain scores, and disease severity will also be recorded. The study setting enables inclusion of a high-volume and diverse pediatric population.

Following discharge, longitudinal follow-up will be conducted using the SCAC tool and sleep diaries at four time points: Day 15, Month 1, Month 2, and Month 3. Parental consent will include approval for follow-up via telephone and SMS reminders. One nurse-researcher will conduct structured phone interviews and provide diary reminders. Post-discharge sleep recovery will be evaluated based on comparison to PICU scores and pre-hospital baseline sleep as reported by parents.

This study is the first in Türkiye, to adapt and validate a sleep screening scale specifically designed for CCC. This research not only focuses on scale development but also aims to generate scientific data that could inform environmental improvements in hospital settings.

Study Timeline

• Study First Submitted: 2025-07-24
• Status Verified: 2025-08
• Study First Submitted QC: 2025-09-29
• Last Update Submitted: 2025-09-29
• Study Start: 2025-10-01
• Study First Posted: 2025-10-07
• Last Update Posted: 2025-10-07
• Primary Completion: 2026-10
• Study Completion: 2027-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

Age 1 month to 18 years At least one complex chronic condition (per 2014 CCC classification) Admission to a pediatric intensive care unit (PICU) Parents willing to participate Parents literate in Turkish

Exclusion Criteria

Parents with insufficient Turkish language proficiency to complete study materials

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Psychometric validation of the Turkish version of the Sleep Screening Scale for Children and Adolescents with Complex Chronic Conditions (SCAC)	At enrollment (hospitalization)	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	At least 4 weeks post-discharge from PICU	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)	At enrollment (hospitalization)	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 Outcome Measures

Name	Time	Method
Objective sleep parameters during PICU stay	During PICU hospitalization (up to 30 days)	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.
Comparison of home and hospital sleep patterns	Home baseline: parent-reported 7 days prior to admission; PICU: Day 7 of admission or at discharge if earlier	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.
Correlation of environmental and clinical factors with sleep efficiency (actigraphy and sleep diaries)	From Day 1 of PICU admission through discharge (up to 30 days)	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
Change in SCAC Scores From Hospitalization to 3 Months Post-Discharge	Baseline (hospitalization),15 days, 1,2, 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.
Time to Return to Pre-Hospital Sleep-Wake Pattern	Baseline (hospitalization),15 days, 1,2, 3 months post-discharge	Caregiver-completed sleep diaries and wake time logs will be used to monitor bedtime, wake time, and daytime napping patterns from hospitalization through 3 months post-discharge. Pre-hospital baseline is defined as the parent-reported sleep diary for the 7 days prior to admission. "Recovery" will be defined as the first date on which the sleep-wake schedule returns to the caregiver's perception of the child's typical pre-hospital pattern, based on diary entries. The primary reported value is the number of days from hospital discharge to recovery (censored at 90 days)
Correlation of clinical and environmental factors with delayed recovery of sleep-wake patterns	From hospital discharge through 90 days post-discharge	Delayed recovery is defined as return to the baseline sleep-wake pattern (caregiver-completed sleep diaries) occurring later than the median recovery time in the study cohort. The primary reported value will be time to recovery (days) after hospital discharge.; Correlation analyses will be conducted with the following predictors: Disease severity: Pediatric Logistic Organ Dysfunction-2 (PELOD-2) daily score,; Complex Chronic Condition (CCC) subtype: e.g., neurologic, cardiac, metabolic, other,; ICU length of stay: days,; Baseline sleep problems: SCAC total score (0-203),; Environmental stressors: Light exposure (lux; measured by actigraphy ambient light channel),; Sound exposure (dB; bedside calibrated sound level meter).

Trial Locations

Locations (1)

Marmara University School of Medicine, Department of Pediatrics, Division of Social Pediatrics; Istanbul, Turkey (Türkiye)