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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05798559
Other study ID # CORAKCI-003
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 5, 2023
Est. completion date August 23, 2023

Study information

Verified date August 2023
Source Bezmialem Vakif University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this clinical trial is to gain importance of sleep routine and environment in mothers have children with neurodevelopmental disorders. The main questions it aims to answer are: - What is the importance of sleep routine and environment in children with neurodevelopmental disorders? - What kind of an effect does the awareness that mothers gain through sleep trainings have? Participants will: - Evaluations will be applied to all participants - Divided into intervention and control groups - The intervention group will be given "Sleep Training" and followed up for about 1 month. - The results between the two groups will be compared Researchers will compare intervention and control groups to see if turning a healthy sleep routine into a life habit


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date August 23, 2023
Est. primary completion date August 15, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - Having a child with a neurodevelopmental disorder - Be over 18 years old and literate - Having a child(s) of pre-school age (3-6 years old) - Communicating and collaborating Exclusion Criteria: - Having a neurological or psychiatric disease that prevents communication and cooperation

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Sleep Training
These are the trainings given by the researchers in order to regulate the sleep routine and environment. Content will be presented to improve sleep processes by arranging living habits.

Locations

Country Name City State
Turkey Bezmialem Vakif University Istanbul I?stanbul

Sponsors (1)

Lead Sponsor Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary The Children's Sleep Habits Questionnaire Questionnaire that has been used in a number of studies to examine sleep behavior in young children. The Questionnaire includes items relating to a number of key sleep domains that encompass the major presenting clinical sleep complaints in this age group: bedtime behavior and sleep onset; sleep duration; anxiety around sleep; behavior occurring during sleep and night wakings; sleep-disordered breathing; parasomnias; and morning waking/daytime sleepiness. 1 month
Secondary Occupational Balance Questionnaire The purpose of the questionnaire is to measure satisfaction according to the amount and variety of daily activities of the individual and to define their occupational balance according to the obtained results. 1 month
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