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Not yet recruitingNCT06012188[Sleep]Updated Aug 25, 2023

Aged 3-6 on Children's Sleeping Habits

An interventional study of sleep toy in Sleep Habits and Child, sponsored by Kilis 7 Aralik University. Not yet recruiting. Open to participants aged 3 Years to 6 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-25.

Sponsored by Kilis 7 Aralik University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Sep 2023, 3 years ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
3 Years to 6 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Sleep Habits
  • Child
03

In context

Lead sponsor

Kilis 7 Aralik University is the lead sponsor of 19 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 6 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Ages ranging from 3 to 6
  • Earthquake living
  • Parents being literate
  • Parents and children who accepted the study and gave voluntary consent

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Experimental group

    Children in the experimental group will be given a sleeping companion toy.

    Other: sleep toy

  • No intervention
    Control group

    No intervention will be made on the control group.

Interventions

  • Othersleep toy

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 15 day

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 25, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06012188
Lead sponsor
Kilis 7 Aralik University
Responsible party
Elif Simay KOÇ (Lecturer, Kilis 7 Aralik University) — Principal investigator
First posted
Aug 25, 2023
Start date
Aug 30, 2023 (estimated)
Primary completion
Sep 13, 2023 (estimated)
Completion
Sep 30, 2023 (estimated)
Last update
Aug 25, 2023

Study contacts

Elif Simay KOÇ
Contact
elifsimay.koc@kilis.edu.tr
05071499746
FATMA KURUDİREK
principal investigator · fsaban@atauni.edu.tr
Türkan KADİROĞLU
principal investigator · t.kadiroglu@atauni.edu.tr

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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