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

Официальное название

Turkish Adaptation and Psychometric Evaluation of the Sleep Screening Tool for Children and Adolescents With Complex Chronic Conditions

Обзор

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).

Подробное описание

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.

Первичные конечные точки

• Psychometric validation of the Turkish version of the Sleep Screening Scale for Children and Adolescents with Complex Chronic Conditions (SCAC) [Срок оценки: At enrollment (hospitalization)]
• Test-retest reliability of the Turkish version of the SCAC [Срок оценки: At least 4 weeks post-discharge from PICU]
• Prevalence and subtype distribution of sleep disturbances in children with Complex Chronic Conditions (CCC) [Срок оценки: At enrollment (hospitalization)]

Вторичные конечные точки (6)

• Objective sleep parameters during PICU stay [Срок оценки: During PICU hospitalization (up to 30 days)]
• Correlation of environmental and clinical factors with sleep efficiency (actigraphy and sleep diaries) [Срок оценки: From Day 1 of PICU admission through discharge (up to 30 days)]
• Comparison of home and hospital sleep patterns [Срок оценки: 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 [Срок оценки: Baseline (hospitalization),15 days, 1,2, 3 months post-discharge]
• Time to Return to Pre-Hospital Sleep-Wake Pattern [Срок оценки: Baseline (hospitalization),15 days, 1,2, 3 months post-discharge]
• Correlation of clinical and environmental factors with delayed recovery of sleep-wake patterns [Срок оценки: From hospital discharge through 90 days post-discharge]

Критерии участия

Критерии включения

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

Критерии исключения

Parents with insufficient Turkish language proficiency to complete study materials

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Turkey (Türkiye) · 1 центр

• Marmara University School of Medicine, Department of Pediatrics, Division of Social Pediat — Istanbul

Публикации

• 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
• 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
• 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
• 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 PMID 36999950
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT07210476 · 24.06.2025-73

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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