Aged 3-6 on Children's Sleeping Habits

Child Clinical Trial

— [Sleep]  

Official title:

The Effect of Sleeping Companion Toy Given to Earthquake Victims Aged 3-6 on Children's Sleeping Habits

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06012188
• Other study ID #: Kilis7AralikU_E_S_KOÇ00
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 30, 2023
• Est. completion date: September 30, 2023

Study information

• Verified date: August 2023
• Source: Kilis 7 Aralik University
• Contact: Elif Simay KOÇ
• Phone: 05071499746
• Email: elifsimay.koc[@]kilis.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: September 30, 2023
• Est. primary completion date: September 13, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 6 Years

Eligibility

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:

• 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

Related Conditions & MeSH terms

• Child
• Sleep Habits

Intervention

Other:
• sleep 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kilis 7 Aralik University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	15 day