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

NCT ID: NCT07210476

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 330 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2027-04-30

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Başakşehir Çam & Sakura City Hospital

OTHER_GOV

Sponsor Role: collaborator

Marmara University

OTHER

Sponsor Role: lead

Responsible Party

Perran Boran

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Elif Ozturk

Role: CONTACT

eozturk@marun.edu.tr

+905056584040

Facility Contacts

Perran Boran

Role: primary

drperran@gmail.com

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Other Identifiers

24.06.2025-73

Identifier Type: -

Identifier Source: org_study_id