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

NCT07210476 | Recruiting

• 1 other identifier: 24.06.2025-73
• Study Type: observational
• Target: 330
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

sleep; sleep disorder; child; chronic disease; actigraphy

Outcome Measures

Primary Outcomes (3)

• 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

  At enrollment (hospitalization)

• 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

  At least 4 weeks post-discharge from PICU

• 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.

  At enrollment (hospitalization)

Secondary Outcomes (6)

• Objective sleep parameters during PICU stay

  During PICU hospitalization (up to 30 days)

• 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)

• 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

• Change in SCAC Scores From Hospitalization to 3 Months Post-Discharge

  Baseline (hospitalization),15 days, 1,2, 3 months post-discharge

• Time to Return to Pre-Hospital Sleep-Wake Pattern

  Baseline (hospitalization),15 days, 1,2, 3 months post-discharge

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children aged 1 months-18 years with at least one complex chronic condition (defined by the 2014 CCC classification)

You may qualify if:

• 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

You may not qualify if:

• Parents with insufficient Turkish language proficiency to complete study materials

Sponsors & Collaborators

• Marmara University: lead
• Başakşehir Çam & Sakura City Hospital: collaborator

Study Sites (1)

Marmara University School of Medicine, Department of Pediatrics, Division of Social Pediatrics

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (16)

• Kubek LA, Claus B, Rostasy K, Bertolini A, Schimmel M, Fruhwald MC, Classen G, Zernikow B, Wager J. Development and preliminary validation of the Sleep Screening for Children and Adolescents with Complex Chronic Conditions (SCAC). J Sleep Res. 2023 Aug;32(4):e13881. doi: 10.1111/jsr.13881. Epub 2023 Mar 16.

  PMID: 36929532 BACKGROUND

• Comrey AL. Factor-analytic methods of scale development in personality and clinical psychology. J Consult Clin Psychol. 1988 Oct;56(5):754-61. doi: 10.1037//0022-006x.56.5.754. No abstract available.

  PMID: 3057010 BACKGROUND

• Kudchadkar SR, Aljohani OA, Punjabi NM. Sleep of critically ill children in the pediatric intensive care unit: a systematic review. Sleep Med Rev. 2014 Apr;18(2):103-10. doi: 10.1016/j.smrv.2013.02.002. Epub 2013 May 21.

  PMID: 23702219 BACKGROUND

• Knauert MP, Ayas NT, Bosma KJ, Drouot X, Heavner MS, Owens RL, Watson PL, Wilcox ME, Anderson BJ, Cordoza ML, Devlin JW, Elliott R, Gehlbach BK, Girard TD, Kamdar BB, Korwin AS, Lusczek ER, Parthasarathy S, Spies C, Sunderram J, Telias I, Weinhouse GL, Zee PC. Causes, Consequences, and Treatments of Sleep and Circadian Disruption in the ICU: An Official American Thoracic Society Research Statement. Am J Respir Crit Care Med. 2023 Apr 1;207(7):e49-e68. doi: 10.1164/rccm.202301-0184ST.

  PMID: 36999950 BACKGROUND

• Hybschmann J, Topperzer MK, Gjaerde LK, Born P, Mathiasen R, Sehested AM, Jennum PJ, Sorensen JL. Sleep in hospitalized children and adolescents: A scoping review. Sleep Med Rev. 2021 Oct;59:101496. doi: 10.1016/j.smrv.2021.101496. Epub 2021 Apr 26.

  PMID: 33984632 BACKGROUND

• Berger J, Zaidi M, Halferty I, Kudchadkar SR. Sleep in the Hospitalized Child: A Contemporary Review. Chest. 2021 Sep;160(3):1064-1074. doi: 10.1016/j.chest.2021.04.024. Epub 2021 Apr 22.

  PMID: 33895129 BACKGROUND

• Adavadkar PA, Brooks L, Pappalardo AA, Schwartz A, Rasinski K, Martin MA. Association between sleep disorders and health care utilization in children with chronic medical conditions: a Medicaid claims data analysis. J Clin Sleep Med. 2024 Apr 1;20(4):595-601. doi: 10.5664/jcsm.10936.

  PMID: 38217477 BACKGROUND

• Namisango E, Bristowe K, Allsop MJ, Murtagh FEM, Abas M, Higginson IJ, Downing J, Harding R. Symptoms and Concerns Among Children and Young People with Life-Limiting and Life-Threatening Conditions: A Systematic Review Highlighting Meaningful Health Outcomes. Patient. 2019 Feb;12(1):15-55. doi: 10.1007/s40271-018-0333-5.

  PMID: 30361884 BACKGROUND

• Dreier LA, Zernikow B, Stening K, Wager J. Insights into the Frequency and Distinguishing Features of Sleep Disorders in Pediatric Palliative Care Incorporating a Systematic Sleep Protocol. Children (Basel). 2021 Jan 17;8(1):54. doi: 10.3390/children8010054.

  PMID: 33477321 BACKGROUND

• Shelton AR, Malow B. Neurodevelopmental Disorders Commonly Presenting with Sleep Disturbances. Neurotherapeutics. 2021 Jan;18(1):156-169. doi: 10.1007/s13311-020-00982-8. Epub 2021 Jan 5.

  PMID: 33403472 BACKGROUND

• Blackmer AB, Feinstein JA. Management of Sleep Disorders in Children With Neurodevelopmental Disorders: A Review. Pharmacotherapy. 2016 Jan;36(1):84-98. doi: 10.1002/phar.1686.

  PMID: 26799351 BACKGROUND

• Bai G, Herten MH, Landgraf JM, Korfage IJ, Raat H. Childhood chronic conditions and health-related quality of life: Findings from a large population-based study. PLoS One. 2017 Jun 2;12(6):e0178539. doi: 10.1371/journal.pone.0178539. eCollection 2017.

  PMID: 28575026 BACKGROUND

• Xavier WDS, Abreu MP, Nunes MDR, Silva-Rodrigues FM, da Silva LF, de Araujo BBM, De Bortoli PS, Neris RR, Nascimento LC. The Sleep Patterns of Children and Adolescents with Chronic Conditions and Their Families: An Integrative Literature Review. Children (Basel). 2024 Feb 6;11(2):207. doi: 10.3390/children11020207.

  PMID: 38397320 BACKGROUND

• Feudtner C, Feinstein JA, Zhong W, Hall M, Dai D. Pediatric complex chronic conditions classification system version 2: updated for ICD-10 and complex medical technology dependence and transplantation. BMC Pediatr. 2014 Aug 8;14:199. doi: 10.1186/1471-2431-14-199.

  PMID: 25102958 BACKGROUND

• Oliveira PV, Enes CC, Nucci LB. How are children with medical complexity being identified in epidemiological studies? A systematic review. World J Pediatr. 2023 Oct;19(10):928-938. doi: 10.1007/s12519-022-00672-9. Epub 2022 Dec 27.

  PMID: 36574212 BACKGROUND

• Marcus KL, Kao PC, Ma C, Wolfe J, DeCourcey DD. Symptoms and Suffering at End of Life for Children With Complex Chronic Conditions. J Pain Symptom Manage. 2022 Jan;63(1):88-97. doi: 10.1016/j.jpainsymman.2021.07.010. Epub 2021 Jul 24.

  PMID: 34311060 BACKGROUND

MeSH Terms

Conditions

Chronic Disease; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Mental Disorders

Central Study Contacts

Elif Ozturk

CONTACT

+905056584040; eozturk@marun.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics, Division of Social Pediatrics, Marmara University School of Medicine, Department of Pediatrics

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: October 7, 2025
• Study Start: March 12, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Available after study completion and publication, for at least 3 years
• Access Criteria: Researchers with methodologically sound proposals may request access by contacting the corresponding author. Data will be shared in accordance with ethical approval and institutional policies.

Locations

TU (1)