Sleep Hygiene Education in Mothers With Preschool Children

• Sponsor: Bezmialem Vakif University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05798559
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 4
• Patients Per Site Per Month: 12.6

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Sleep; Habits; Neurodevelopmental Disorders	Behavioral: Sleep Training	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized Controlled Trial Mothers of children with neurodevelopmental disorders will be included in the study. Inclusion criteria for the study: 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 Intervention and study group will be formed by simple randomization.Randomized Controlled Trial Mothers of children with neurodevelopmental disorders will be included in the study.Inclusion criteria for the study: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 Intervention and study group will be formed by simple randomization.
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Investigation of the Effectiveness of Sleep Hygiene Education in Mothers With Preschool Children: A Randomized Controlled Study
• Anticipated Study Start Date: Apr 1, 2023
• Anticipated Primary Completion Date: Jun 1, 2023
• Anticipated Study Completion Date: Jul 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Group "Sleep Training" will be applied. With the training, examples will be presented to mothers that they can apply in their daily lives. 1 month will be followed	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.
No Intervention: Control Group No training will be provided note: "Sleep Training" will be given after the study is completed so that the control group is not victimized.

Outcome Measures

Primary Outcome Measures

1. The Children's Sleep Habits Questionnaire [1 month]

   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.

Secondary Outcome Measures

1. Occupational Balance Questionnaire [1 month]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bezmialem Vakıf University	Istanbul	İ̇stanbul	Turkey	34762

Sponsors and Collaborators

• Bezmialem Vakif University

Investigators

• Study Chair: Kardelen Yıldırım, Lecturer, Bezmialem Vakif University
• Study Director: Gülşah Zengin, Lecturer, Bezmialem Vakif University
• Study Director: Sultan Akel, Lecturer, Bezmialem Vakif University
• Principal Investigator: Sümeyye Sarışahin, Researcher, Bezmialem Vakif University
• Principal Investigator: Beyzanur Demirci, Researcher, Bezmialem Vakif University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zeynep Çorakcı Yazıcıoğlu, Principal Investigator, Bezmialem Vakif University
• ClinicalTrials.gov Identifier: NCT05798559
• Other Study ID Numbers: CORAKCİ-003
• First Posted: Apr 4, 2023
• Last Update Posted: Apr 4, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Zeynep Çorakcı Yazıcıoğlu, Principal Investigator, Bezmialem Vakif University: Sleep Hygiene; Neurodevelopmental Disorders
• Additional relevant MeSH terms: Neurodevelopmental Disorders

Study Results

No Results Posted as of Apr 4, 2023