Aged 3-6 on Children's Sleeping Habits

NCT ID: NCT06012188

Last Updated: 2023-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-30

Study Completion Date

2023-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Sleep Habits Child

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Experimental group

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

Group Type EXPERIMENTAL

sleep toy

Intervention Type 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.

Control group

No intervention will be made on the control group.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kilis 7 Aralik University

OTHER

Sponsor Role lead

Responsible Party

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Elif Simay KOÇ

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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FATMA KURUDİREK

Role: PRINCIPAL_INVESTIGATOR

[email protected]

Türkan KADİROĞLU

Role: PRINCIPAL_INVESTIGATOR

[email protected]

Central Contacts

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Elif Simay KOÇ

Role: CONTACT

05071499746

Other Identifiers

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Kilis7AralikU_E_S_KOÇ00

Identifier Type: -

Identifier Source: org_study_id

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