Sleep Hygiene Education in Mothers With Preschool Children

Back to results

Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Sleep Training

About this trial

This is an interventional supportive care trial for Sleep focused on measuring Sleep Hygiene, Neurodevelopmental Disorders

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Bezmialem Vakıf University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

"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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT05798559

First Posted

March 23, 2023

Last Updated

August 23, 2023

Sponsor

Bezmialem Vakif University

1. Study Identification

Unique Protocol Identification Number

NCT05798559

Brief Title

Sleep Hygiene Education in Mothers With Preschool Children

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

June 5, 2023 (Actual)

Primary Completion Date

August 15, 2023 (Actual)

Study Completion Date

August 23, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Bezmialem Vakif University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sleep, Habits, Neurodevelopmental Disorders

Keywords

Sleep Hygiene, Neurodevelopmental Disorders

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

35 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention Group

Arm Type

Experimental

Arm Description

"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

Arm Title

Control Group

Arm Type

No Intervention

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Sleep Training

Intervention Description

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.

Primary Outcome Measure Information:

Title

The Children's Sleep Habits Questionnaire

Description

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.

Time Frame

1 month

Secondary Outcome Measure Information:

Title

Occupational Balance Questionnaire

Description

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.

Time Frame

1 month

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

To be a mother

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials: