Sleep Habits[Sleep]NCT06012188
Aged 3-6 on Children's Sleeping Habits
A study testing sleep toy in people with Sleep Habits and Child, run by Kilis 7 Aralik University.
Trial summary
One of the most important points in sleep health is the sleep habits of children. Natural disasters cause sleep problems in children, increase or decrease in sleep duration, change in sleep habits and adversely affect sleep quality. Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Habits, Child
- What is being tested?
- sleep toy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 30 Aug 2023to 30 Sep 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 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Ages ranging from 3 to 6
- Earthquake living
- Parents being literate
- Parents and children who accepted the study and gave voluntary consent
Who cannot join
- Being a 3-6 year old child who has previously had a sleep disorder finding
- Being visually, hearing or speech impaired
- Children aged 3-6 with mental disorders
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Sleeping Companion Toy Given to Earthquake Victims Aged 3-6 on Children's Sleeping Habits
One of the most important points in sleep health is the sleep habits of children. Natural disasters cause sleep problems in children, increase or decrease in sleep duration, change in sleep habits and adversely affect sleep quality. According to Erikson's theory of psychosocial development, children aged 3-6 are entrepreneurs. It is the period when children begin to learn and apply the rules, and independence efforts are developed in the child. Negative sleep behaviors and sleep problems are common during this period, but children can develop positive sleep habits if properly and consistently guided by their parents. Rituals such as fairy tales, lullabies, night lamps, toys can help children relax and calm down and gain sleep habits.
Read the detailed description
The research design is a randomized controlled experimental type study designed to evaluate the effect of sleeping companion toys given to earthquake survivors aged 3-6 years on children's sleep habits.The Children's Sleep Habits Scale will be used to determine the sleep habits of children in the earthquake area by pre-interviewing the parents of children aged 3-6. Children aged 3-6 with sleep problems will be divided into control and experimental groups according to their scale scores. The part up to this section constitutes the preliminary test of our research.
Children aged 3-6 years in the control group and their parents will not receive any intervention.
Families of the children in the experimental group will be given a sleep companion gift to give to their children. Children's sleep habits scale will be applied as a post-test to determine children's sleep problems 15 days after they receive a gift from their sleep friend. Then, sleep habits scale mean scores will be calculated and a comparison will be made between pretest and posttest mean scores.
- Conditions
- Sleep Habits, Child
- Being tested
- sleep toy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sleep toyOther
The parents of the children in the experimental group will be given a sleeping companion toy to present to their children. At the end of 15 days, the Children's Sleep Habits scale will be applied as a post-test to evaluate the effect of the sleep companion toy.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Children in the experimental group will be given a sleeping companion toy. Receives: Other: sleep toy |
| Control group | No intervention | No intervention will be made on the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's Sleep Habits Scale
The Children's Sleep Habits Scale will be used to determine children's sleep habits and sleep-related problems. Children's Sleep Habits Scale consists of 8 sub-dimensions and a total of 33 items.In grading the scale, parents are asked to respond as 1=rarely (0-1 times a week), 2=sometimes (2-4 times a week), and 3=usually (5-7 times a week). A minimum of 33 points and a maximum of 99 points are taken from the scale. The total test score is obtained by summing the scores obtained from the items one by one.
It is accepted that those who have a total score of 41 and above with CIAS have clinical sleep problems.
Measured: 15 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start30 Aug 2023 (estimated)
- Primary completion13 Sep 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep HabitsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kilis 7 Aralik University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Simay KOÇ, Kilis 7 Aralik University
- Investigators
- FATMA KURUDİREK, Principal investigator, fsaban@atauni.edu.trTürkan KADİROĞLU, Principal investigator, t.kadiroglu@atauni.edu.tr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06012188
- Sponsor's protocol ID
- Kilis7AralikU_E_S_KOÇ00
- Acronym
- [Sleep]
- Status last verified
- Aug 2023
- First submitted
- 21 Aug 2023
- Last updated
- 25 Aug 2023
- Results posted
- No
- Data monitoring committee
- 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 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sleeping Companion Toy Given to Earthquake Victims Aged 3-6 on Children's Sleeping Habits
- ClinicalTrials.gov ID
- NCT06012188
- Acronym / sponsor ID
- [Sleep] / Kilis7AralikU_E_S_KOÇ00
- Conditions
- Sleep Habits, Child
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kilis 7 Aralik UniversityUniversity, hospital or other
- Study start
- 30 Aug 2023 (estimated)
- Primary completion
- 13 Sep 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 25 Aug 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.
One of the most important points in sleep health is the sleep habits of children. Natural disasters cause sleep problems in children, increase or decrease in sleep duration, change in sleep habits and adversely affect sleep quality. According to Erikson's theory of psychosocial development, children aged 3-6 are entrepreneurs. It is the period when children begin to learn and apply the rules, and independence efforts are developed in the child. Negative sleep behaviors and sleep problems are common during this period, but children can develop positive sleep habits if properly and consistently guided by their parents. Rituals such as fairy tales, lullabies, night lamps, toys can help children relax and calm down and gain sleep habits.
Detailed description
The research design is a randomized controlled experimental type study designed to evaluate the effect of sleeping companion toys given to earthquake survivors aged 3-6 years on children's sleep habits.The Children's Sleep Habits Scale will be used to determine the sleep habits of children in the earthquake area by pre-interviewing the parents of children aged 3-6. Children aged 3-6 with sleep problems will be divided into control and experimental groups according to their scale scores. The part up to this section constitutes the preliminary test of our research.
Children aged 3-6 years in the control group and their parents will not receive any intervention.
Families of the children in the experimental group will be given a sleep companion gift to give to their children. Children's sleep habits scale will be applied as a post-test to determine children's sleep problems 15 days after they receive a gift from their sleep friend. Then, sleep habits scale mean scores will be calculated and a comparison will be made between pretest and posttest mean scores.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: sleep toyChildren in the experimental group will be given a sleeping companion toy. |
| Control group | No intervention | –No intervention will be made on the control group. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Ages ranging from 3 to 6
- Earthquake living
- Parents being literate
- Parents and children who accepted the study and gave voluntary consent
Key exclusion criteria (3 listed)
- Being a 3-6 year old child who has previously had a sleep disorder finding
- Being visually, hearing or speech impaired
- Children aged 3-6 with mental disorders
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 toyThe parents of the children in the experimental group will be given a sleeping companion toy to present to their children. At the end of 15 days, the Children's Sleep Habits scale will be applied as a post-test to evaluate the effect of the sleep companion toy. | Other | Experimental group |
Primary outcome
Children's Sleep Habits Scale
Time frame: 15 day
The Children's Sleep Habits Scale will be used to determine children's sleep habits and sleep-related problems. Children's Sleep Habits Scale consists of 8 sub-dimensions and a total of 33 items.In grading the scale, parents are asked to respond as 1=rarely (0-1 times a week), 2=sometimes (2-4 times a week), and 3=usually (5-7 times a week). A minimum of 33 points and a maximum of 99 points are taken from the scale. The total test score is obtained by summing the scores obtained from the items one by one. It is accepted that those who have a total score of 41 and above with CIAS have clinical sleep problems.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for Sleep Habits
Recruiting
Tiny Tummies - A Milk Study
Gut Microbiome, Neurocognitive Correlates of Eating Habits
Recruiting
Physical Activity, Sleep Quality, and Respiratory Function in Obstructive Sleep Apnea
Obstructive Sleep Apnea, Sleep Quality
Active, not recruiting
StandUPTV Habits: Feasibility Trial for Maintaining Reductions in Sedentary Screen Time
Sedentary Behaviors, Screen Time
Not yet recruiting
Impact of Lifestyle on Health Maintenance: A Randomized Controlled Trial
Metabolic Syndrome, Inactivity/Low Levels of Exercise
Recruiting
Circadian Intervention to Improve Cardiometabolic Health
Cardiometabolic Syndrome, Type 2 Diabetes
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.
FATMA KURUDİREK principal investigator
fsaban@atauni.edu.tr
Türkan KADİROĞLU principal investigator
t.kadiroglu@atauni.edu.tr
Questions about this trial
What is this clinical trial studying?
A study testing sleep toy in people with Sleep Habits and Child, run by Kilis 7 Aralik University.
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 3 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: status not confirmed, as of the sponsor's last update on 25 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elif Simay KOÇ (05071499746, elifsimay.koc@kilis.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children's Sleep Habits Scale (time frame: 15 day). 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 25 Aug 2023.