Sleep Hygiene Education in Mothers With Preschool Children

NCT05798559 | Completed

• 1 other identifier: CORAKCİ-003
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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

Conditions

Sleep; Habits; Neurodevelopmental Disorders

Keywords

Sleep Hygiene; Neurodevelopmental Disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Occupational Balance Questionnaire

  1 month

Study Arms (2)

Intervention Group

EXPERIMENTAL

* "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

Control Group

NO INTERVENTION

No training will be provided note: "Sleep Training" will be given after the study is completed so that the control group is not victimized.

Interventions

Sleep Training BEHAVIORAL

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: To be a mother
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Having a neurological or psychiatric disease that prevents communication and cooperation

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakıf University

Istanbul, İ̇stanbul, 34762, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Habits; Neurodevelopmental Disorders; Sleep Hygiene

Condition Hierarchy (Ancestors)

Behavior; Mental Disorders; Health Behavior

Study Officials

• Kardelen Yıldırım, Lecturer

  Bezmialem Vakif University

  STUDY CHAIR

• Gülşah Zengin, Lecturer

  Bezmialem Vakif University

  STUDY DIRECTOR

• Sultan Akel, Lecturer

  Bezmialem Vakif University

  STUDY DIRECTOR

• Sümeyye Sarışahin, Researcher

  Bezmialem Vakif University

  PRINCIPAL INVESTIGATOR

• Beyzanur Demirci, Researcher

  Bezmialem Vakif University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: April 4, 2023
• Study Start: June 5, 2023
• Primary Completion: August 15, 2023
• Study Completion: August 23, 2023
• Last Updated: August 24, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 9 months
• Access Criteria: Principal investigator will provide access.

Locations

TU (1)