SleepNCT05798559
Sleep Hygiene Education in Mothers With Preschool Children
A study testing Sleep Training in people with Sleep and Habits, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to gain importance of sleep routine and environment in mothers have children with neurodevelopmental disorders. The main questions it aims to answer are: What is the importance of sleep routine and environment in children with neurodevelopmental disorders? What kind of an effect does… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sleep, Habits, Neurodevelopmental Disorders
- What is being tested?
- Sleep Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jun 2023to 23 Aug 2023
- Phase
- Interventional
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Having a child with a neurodevelopmental disorder
- Be over 18 years old and literate
- Having a child(s) of pre-school age (3-6 years old)
- Communicating and collaborating
Who cannot join
- Having a neurological or psychiatric disease that prevents communication and cooperation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bezmialem Vakıf University
Istanbul, İ̇stanbul, 34762
About this study
Official title: Investigation of the Effectiveness of Sleep Hygiene Education in Mothers With Preschool Children: A Randomized Controlled Study
The goal of this clinical trial is to gain importance of sleep routine and environment in mothers have children with neurodevelopmental disorders. The main questions it aims to answer are:
- What is the importance of sleep routine and environment in children with neurodevelopmental disorders?
- What kind of an effect does the awareness that mothers gain through sleep trainings have?
Read more
Participants will:
- Evaluations will be applied to all participants
- Divided into intervention and control groups
- The intervention group will be given "Sleep Training" and followed up for about 1 month.
- The results between the two groups will be compared
Researchers will compare intervention and control groups to see if turning a healthy sleep routine into a life habit
- Conditions
- Sleep, Habits, Neurodevelopmental Disorders
- Being tested
- Sleep Training
- Keywords
- Sleep Hygiene, Neurodevelopmental Disorders
- Medical subject headings
- Habits, Neurodevelopmental Disorders, Sleep Hygiene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep TrainingBehavioural
These are the trainings given by the researchers in order to regulate the sleep routine and environment. Content will be presented to improve sleep processes by arranging living habits.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | * "Sleep Training" will be applied.
* With the training, examples will be presented to mothers that they can apply in their daily lives.
* 1 month will be followed Receives: Behavioral: Sleep Training |
| Control Group | No intervention | No training will be provided note: "Sleep Training" will be given after the study is completed so that the control group is not victimized. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Children's Sleep Habits Questionnaire
Questionnaire that has been used in a number of studies to examine sleep behavior in young children. The Questionnaire includes items relating to a number of key sleep domains that encompass the major presenting clinical sleep complaints in this age group: bedtime behavior and sleep onset; sleep duration; anxiety around sleep; behavior occurring during sleep and night wakings; sleep-disordered breathing; parasomnias; and morning waking/daytime sleepiness.
Measured: 1 month
Secondary outcomes (1)
Occupational Balance Questionnaire
The purpose of the questionnaire is to measure satisfaction according to the amount and variety of daily activities of the individual and to define their occupational balance according to the obtained results.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study start5 Jun 2023
- Primary completion15 Aug 2023
- Study completion23 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial Mothers of children with neurodevelopmental disorders will be included in the study. Inclusion criteria for the study: * Having a child with a neurodevelopmental disorder * Be over 18 years old and literate * Having a child(s) of pre-school age (3-6 years old) * Communicating and collaborating Intervention and study group will be formed by simple randomization.
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Çorakcı Yazıcıoğlu, Bezmialem Vakif University
- Investigators
- Kardelen Yıldırım, Lecturer, Study chair, Bezmialem Vakif UniversityGülşah Zengin, Lecturer, Study director, Bezmialem Vakif UniversitySultan Akel, Lecturer, Study director, Bezmialem Vakif UniversitySümeyye Sarışahin, Researcher, Principal investigator, Bezmialem Vakif UniversityBeyzanur Demirci, Researcher, Principal investigator, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05798559
- Sponsor's protocol ID
- CORAKCİ-003
- Status last verified
- Aug 2023
- First submitted
- 23 Mar 2023
- Last updated
- 24 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: It will be shared with researchers who offer suggestions to improve the the study being carried out
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of Sleep Hygiene Education in Mothers With Preschool Children: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05798559
- Acronym / sponsor ID
- CORAKCİ-003
- Conditions
- Sleep, Habits, Neurodevelopmental Disorders
- Keywords
- Sleep Hygiene, Neurodevelopmental Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 5 Jun 2023 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 23 Aug 2023 (actual)
- First posted
- 4 Apr 2023 (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.
The goal of this clinical trial is to gain importance of sleep routine and environment in mothers have children with neurodevelopmental disorders. The main questions it aims to answer are:
- What is the importance of sleep routine and environment in children with neurodevelopmental disorders?
- What kind of an effect does the awareness that mothers gain through sleep trainings have?
Participants will:
- Evaluations will be applied to all participants
- Divided into intervention and control groups
- The intervention group will be given "Sleep Training" and followed up for about 1 month.
- The results between the two groups will be compared
Researchers will compare intervention and control groups to see if turning a healthy sleep routine into a life habit
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial Mothers of children with neurodevelopmental disorders will be included in the study. Inclusion criteria for the study: * Having a child with a neurodevelopmental disorder * Be over 18 years old and literate * Having a child(s) of pre-school age (3-6 years old) * Communicating and collaborating Intervention and study group will be formed by simple randomization.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Sleep Training* "Sleep Training" will be applied. * With the training, examples will be presented to mothers that they can apply in their daily lives. * 1 month will be followed |
| Control Group | No intervention | –No training will be provided note: "Sleep Training" will be given after the study is completed so that the control group is not victimized. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Having a child with a neurodevelopmental disorder
- Be over 18 years old and literate
- Having a child(s) of pre-school age (3-6 years old)
- Communicating and collaborating
Key exclusion criteria (1 listed)
- Having a neurological or psychiatric disease that prevents communication and cooperation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep TrainingThese are the trainings given by the researchers in order to regulate the sleep routine and environment. Content will be presented to improve sleep processes by arranging living habits. | Behavioural | Intervention Group |
Primary outcome
The Children's Sleep Habits Questionnaire
Time frame: 1 month
Questionnaire that has been used in a number of studies to examine sleep behavior in young children. The Questionnaire includes items relating to a number of key sleep domains that encompass the major presenting clinical sleep complaints in this age group: bedtime behavior and sleep onset; sleep duration; anxiety around sleep; behavior occurring during sleep and night wakings; sleep-disordered breathing; parasomnias; and morning waking/daytime sleepiness.
1 secondary outcome
Occupational Balance Questionnaire
Time frame: 1 month
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 24 Aug 2023.
- Individual participant dataSharing planned: Yes. It will be shared with researchers who offer suggestions to improve the the study being carried out
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Healthy Adult Participants
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.
Kardelen Yıldırım, Lecturer study chair
Bezmialem Vakif University
Gülşah Zengin, Lecturer study director
Bezmialem Vakif University
Sultan Akel, Lecturer study director
Bezmialem Vakif University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Training in people with Sleep and Habits, run by Bezmialem Vakif University 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 4 inclusion and 1 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 24 Aug 2023. 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?
The Children's Sleep Habits Questionnaire (time frame: 1 month). 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 24 Aug 2023.