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

April 16, 2026 updated by: Perran Boran, Marmara University

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
330

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye)
        • Recruiting
        • Marmara University School of Medicine, Department of Pediatrics, Division of Social Pediatrics
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

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)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Psychometric validation of the Turkish version of the Sleep Screening Scale for Children and Adolescents with Complex Chronic Conditions (SCAC)
Time Frame: 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
At enrollment (hospitalization)
Test-retest reliability of the Turkish version of the SCAC
Time Frame: 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
At least 4 weeks post-discharge from PICU
Prevalence and subtype distribution of sleep disturbances in children with Complex Chronic Conditions (CCC)
Time Frame: 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.
At enrollment (hospitalization)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Objective sleep parameters during PICU stay
Time Frame: 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.
During PICU hospitalization (up to 30 days)
Correlation of environmental and clinical factors with sleep efficiency (actigraphy and sleep diaries)
Time Frame: 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
From Day 1 of PICU admission through discharge (up to 30 days)
Comparison of home and hospital sleep patterns
Time Frame: 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.
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
Time Frame: 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.
Baseline (hospitalization),15 days, 1,2, 3 months post-discharge
Time to Return to Pre-Hospital Sleep-Wake Pattern
Time Frame: 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)
Baseline (hospitalization),15 days, 1,2, 3 months post-discharge
Correlation of clinical and environmental factors with delayed recovery of sleep-wake patterns
Time Frame: 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).
From hospital discharge through 90 days post-discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Marmara University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Başakşehir Çam & Sakura City Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 12, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 24, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 7, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 24.06.2025-73

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data may be shared upon reasonable request depending on ethical approvals, participant consent, and institutional policies. Any data sharing will follow strict guidelines to ensure confidentiality and data protection, especially due to the involvement of pediatric patients with complex medical conditions. Requests for sharing of individual participant data will be evaluated on a case-by-case basis. If researchers express interest (e.g., based on publications or institutional announcements), data sharing requests can be submitted through a formal application process.

IPD Sharing Time Frame

Available after study completion and publication, for at least 3 years

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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