Sleep ProblemsNCT07476612
Sleep Patterns in Children Aged 0-36 Months and Maternal Anxiety and Depression
An observational study of Sleep Problems and Maternal Anxiety, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
Trial summary
In this study, the investigators aimed to investigate the relationship between the sleep patterns of children aged 0-36 months hospitalized in the general pediatrics clinic and their mothers' anxiety and depression levels. Read more about this study
- Who is it for?
- Ages 1 month to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Sleep Problems, Maternal Anxiety
- How many people
- 110 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Oct 2025to 27 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: This study includes children aged 0-36 months and their mothers. Children's sleep patterns were assessed using the Brief Infant Sleep Questionnaire (BISQ). Mothers' anxiety and depression levels were assessed using validated questionnaires (The Beck Depression Inventory (BDI) and Beck Anxiety Inventory (BAI)). Participants were recruited from pediatric inpatient clinics.
Who may be able to join
- Children aged 0-36 months hospitalized in the general pediatrics clinic and their mothers
Who cannot join
- Outpatients,
- Newborns aged 0-29 days,
- Patients over 3 years of age,
- Infants diagnosed with chronic diseases,
- Infants diagnosed sleep disorders,
- Mothers diagnosed with psychiatric disorders,
- Mothers receiving regular medical treatment for anxiety and depression disorders
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Basaksehir Cam ve Sakura City Hospital
Başakşehir, İ̇stanbul, 34107
About this study
Official title: Maternal Anxiety and Depression and Their Association With Sleep Patterns in Children Aged 0-36 Months
In this study, the investigators aimed to investigate the relationship between the sleep patterns of children aged 0-36 months hospitalized in the general pediatrics clinic and their mothers' anxiety and depression levels.
Read the detailed description
Sleep problems during infancy and early childhood are common and may affect both child development and family well-being. Maternal psychological status, particularly anxiety and depression, may play an important role in shaping infant sleep patterns through behavioral and environmental mechanisms. Understanding this relationship may help identify families at risk and contribute to early supportive interventions.
This observational study aims to investigate the relationship between sleep patterns of children aged 0-36 months and maternal anxiety and depression levels. Infant sleep characteristics, including total sleep duration, number of night awakenings, and sleep quality, will be assessed using the Brief Infant Sleep Questionnaire-Revised (BISQ-R) completed by mothers.
Maternal psychological status will be evaluated using validated psychological assessment tools. Maternal depression will be assessed using the Beck Depression Inventory (BDI), while maternal anxiety levels will be assessed using the Beck Anxiety Inventory (BAI).
The association between infant sleep parameters and maternal anxiety and depression scores will be analyzed to evaluate the potential relationship between maternal psychological status and infant sleep patterns in children aged 0-36 months. The findings of this study are expected to improve understanding of factors influencing sleep during early childhood and may help inform early supportive strategies for families.
- Conditions
- Sleep Problems, Maternal Anxiety
- Keywords
- Early childhood, Sleep problems, Maternal anxiety, Depression, Maternal mental health
- Medical subject headings
- Parasomnias, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hospitalized infants (0-36 months) and mothers | Single cohort of mother-infant dyads with infants aged 0-36 months hospitalized in the pediatric inpatient ward. Maternal anxiety and depressive symptoms were assessed using the Beck Anxiety Inventory (BAI) and Beck Depression Inventory (BDI). Infant sleep characteristics were assessed using the Brief Infant Sleep Questionnaire (BISQ). No intervention was administered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spearman Correlation Between Maternal Anxiety and Infant Sleep Status
Spearman correlation (rho) between maternal Beck Anxiety Inventory (BAI) total score (0-63 points) and infant total sleep duration (hours) assessed by the Brief Infant Sleep Questionnaire (BISQ) at enrollment during inpatient hospitalization. Unit of measure: Spearman rho (correlation coefficient).
Measured: single assessment at enrollment during inpatient hospitalization
Secondary outcomes (3)
Correlation Between Maternal Depression and Infant Sleep Status
pearman correlation (rho) between maternal Beck Depression Inventory (BDI) total score (0-63 points) and infant total sleep duration (hours) assessed by BISQ at enrollment during inpatient hospitalization. Unit of measure: Spearman rho.
Measured: single assessment at enrollment during inpatient hospitalization
Maternal Anxiety Score by Infant Sleep Disorder Status
Comparison of maternal BAI total score (0-63 points) between infants with vs without BISQ-defined sleep disorder (>3 night awakenings OR >60 min nocturnal wakefulness OR <9 h total sleep duration) at enrollment during inpatient hospitalization. Unit of measure: BAI total scores.
Measured: Baseline (single assessment at enrollment during inpatient hospitalization)
Sleep Disorder Proportion by Maternal Sleep Satisfaction
Proportion of infants with BISQ-defined sleep disorder compared across maternal sleep satisfaction categories (very satisfied, moderately satisfied, not satisfied) assessed at enrollment during inpatient hospitalization. Unit of measure: % (proportion).
Measured: Baseline (single assessment at enrollment during inpatient hospitalization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start22 Oct 2025
- Primary completion15 Jan 2026
- Study completion27 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ProblemsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Başakşehir Çam & Sakura City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Şeymanur Uçum, Başakşehir Çam & Sakura City Hospital
- Investigators
- Furkan ÇOLAK, Principal investigator, Basaksehir Cam and Sakura City Hospital, Istanbul, TurkeyŞeymanur UÇUM, MD, Principal investigator, Basaksehir Cam and Sakura City Hospital, Istanbul, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07476612
- Sponsor's protocol ID
- BCSSH-SBU-ŞU-12
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Anxiety and Depression and Their Association With Sleep Patterns in Children Aged 0-36 Months
- ClinicalTrials.gov ID
- NCT07476612
- Acronym / sponsor ID
- BCSSH-SBU-ŞU-12
- Conditions
- Sleep Problems, Maternal Anxiety
- Keywords
- Early childhood, Sleep problems, Maternal anxiety, Depression, Maternal mental health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Başakşehir Çam & Sakura City HospitalOther government
- Study start
- 22 Oct 2025 (actual)
- Primary completion
- 15 Jan 2026 (actual)
- Study completion
- 27 Feb 2026 (actual)
- First posted
- 17 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, the investigators aimed to investigate the relationship between the sleep patterns of children aged 0-36 months hospitalized in the general pediatrics clinic and their mothers' anxiety and depression levels.
Detailed description
Sleep problems during infancy and early childhood are common and may affect both child development and family well-being. Maternal psychological status, particularly anxiety and depression, may play an important role in shaping infant sleep patterns through behavioral and environmental mechanisms. Understanding this relationship may help identify families at risk and contribute to early supportive interventions.
This observational study aims to investigate the relationship between sleep patterns of children aged 0-36 months and maternal anxiety and depression levels. Infant sleep characteristics, including total sleep duration, number of night awakenings, and sleep quality, will be assessed using the Brief Infant Sleep Questionnaire-Revised (BISQ-R) completed by mothers.
Maternal psychological status will be evaluated using validated psychological assessment tools. Maternal depression will be assessed using the Beck Depression Inventory (BDI), while maternal anxiety levels will be assessed using the Beck Anxiety Inventory (BAI).
The association between infant sleep parameters and maternal anxiety and depression scores will be analyzed to evaluate the potential relationship between maternal psychological status and infant sleep patterns in children aged 0-36 months. The findings of this study are expected to improve understanding of factors influencing sleep during early childhood and may help inform early supportive strategies for families.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hospitalized infants (0-36 months) and mothers | – | –Single cohort of mother-infant dyads with infants aged 0-36 months hospitalized in the pediatric inpatient ward. Maternal anxiety and depressive symptoms were assessed using the Beck Anxiety Inventory (BAI) and Beck Depression Inventory (BDI). Infant sleep characteristics were assessed using the Brief Infant Sleep Questionnaire (BISQ). No intervention was administered. |
Who may qualify
- Ages
- 1 month to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- This study includes children aged 0-36 months and their mothers. Children's sleep patterns were assessed using the Brief Infant Sleep Questionnaire (BISQ). Mothers' anxiety and depression levels were assessed using validated questionnaires (The Beck Depression Inventory (BDI) and Beck Anxiety Inventory (BAI)). Participants were recruited from pediatric inpatient clinics.
Key inclusion criteria (1 listed)
- Children aged 0-36 months hospitalized in the general pediatrics clinic and their mothers
Key exclusion criteria (7 listed)
- Outpatients,
- Newborns aged 0-29 days,
- Patients over 3 years of age,
- Infants diagnosed with chronic diseases,
- Infants diagnosed sleep disorders,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Spearman Correlation Between Maternal Anxiety and Infant Sleep Status
Time frame: single assessment at enrollment during inpatient hospitalization
Spearman correlation (rho) between maternal Beck Anxiety Inventory (BAI) total score (0-63 points) and infant total sleep duration (hours) assessed by the Brief Infant Sleep Questionnaire (BISQ) at enrollment during inpatient hospitalization. Unit of measure: Spearman rho (correlation coefficient).
3 secondary outcomes
Correlation Between Maternal Depression and Infant Sleep Status
Time frame: single assessment at enrollment during inpatient hospitalization
Maternal Anxiety Score by Infant Sleep Disorder Status
Time frame: Baseline (single assessment at enrollment during inpatient hospitalization)
Sleep Disorder Proportion by Maternal Sleep Satisfaction
Time frame: Baseline (single assessment at enrollment during inpatient hospitalization)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Furkan ÇOLAK principal investigator
Basaksehir Cam and Sakura City Hospital, Istanbul, Turkey
Şeymanur UÇUM, MD principal investigator
Basaksehir Cam and Sakura City Hospital, Istanbul, Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Problems and Maternal Anxiety, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spearman Correlation Between Maternal Anxiety and Infant Sleep Status (time frame: single assessment at enrollment during inpatient hospitalization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.