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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06012188
Other study ID # Kilis7AralikU_E_S_KOÇ00
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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