[Sleep]: Aged 3-6 on Children's Sleeping Habits

Sponsor
Kilis 7 Aralik University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06012188
Collaborator
(none)
60
2
1

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: sleep toy
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
The Effect of Sleeping Companion Toy Given to Earthquake Victims Aged 3-6 on Children's Sleeping Habits
Anticipated Study Start Date :
Aug 30, 2023
Anticipated Primary Completion Date :
Sep 13, 2023
Anticipated Study Completion Date :
Sep 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental group

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

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.

No Intervention: Control group

No intervention will be made on the control group.

Outcome Measures

Primary Outcome Measures

  1. Children's Sleep Habits Scale [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Years to 6 Years
Sexes Eligible for Study:
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:
  • 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Kilis 7 Aralik University

Investigators

  • Principal Investigator: FATMA KURUDİREK, fsaban@atauni.edu.tr
  • Principal Investigator: Türkan KADİROĞLU, t.kadiroglu@atauni.edu.tr

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Elif Simay KOÇ, Lecturer, Kilis 7 Aralik University
ClinicalTrials.gov Identifier:
NCT06012188
Other Study ID Numbers:
  • Kilis7AralikU_E_S_KOÇ00
First Posted:
Aug 25, 2023
Last Update Posted:
Aug 25, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 25, 2023