Sleep Hygiene Education in Mothers With Preschool Children

Investigation of the Effectiveness of Sleep Hygiene Education in Mothers With Preschool Children: A Randomized Controlled Study

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

Study Overview

• Status: Completed
• Conditions: Sleep; Neurodevelopmental Disorders; Habits
• Intervention / Treatment: Behavioral: Sleep Training

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • İ̇stanbul
    • Istanbul, İ̇stanbul, Turkey, 34762
      • Bezmialem Vakıf University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start (Actual): June 5, 2023
• Primary Completion (Actual): August 15, 2023
• Study Completion (Actual): August 23, 2023

Study Registration Dates

• First Submitted: March 23, 2023
• First Submitted That Met QC Criteria: March 23, 2023
• First Posted (Actual): April 4, 2023

Study Record Updates

• Last Update Posted (Actual): August 24, 2023
• Last Update Submitted That Met QC Criteria: August 23, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Neurodevelopmental Disorders; Sleep Hygiene
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders
• Other Study ID Numbers: CORAKCİ-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: It will be shared with researchers who offer suggestions to improve the the study being carried out
• IPD Sharing Time Frame: 9 months
• IPD Sharing Access Criteria: Principal investigator will provide access.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No