Aged 3-6 on Children's Sleeping Habits

NCT06012188 | Unknown

• 1 other identifier: Kilis7AralikU_E_S_KOÇ00
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sleep Habits; Child

Outcome Measures

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.

  15 day

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Other: sleep toy

Control group

NO INTERVENTION

No intervention will be made on the control group.

Interventions

sleep toy OTHER

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.

Experimental group

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kilis 7 Aralik University: lead

Study Officials

• FATMA KURUDİREK

  fsaban@atauni.edu.tr

  PRINCIPAL INVESTIGATOR

• Türkan KADİROĞLU

  t.kadiroglu@atauni.edu.tr

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elif Simay KOÇ

CONTACT

05071499746; elifsimay.koc@kilis.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: August 25, 2023
• Study Start: August 30, 2023
• Primary Completion: September 13, 2023
• Study Completion: September 30, 2023
• Last Updated: August 25, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share