- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05828290
The Effect of Yoga on Gaining Sleep Habits in Children (YPK)
April 27, 2023 updated by: Ayşegül İşler Dalgıç, Akdeniz University
The Effect of the Little Yogis do Yoga Program on Sleeping Habits in Pre-school Children: Randomized Controlled Trial
This study was planned to determine the effect of the "Little Yogis Doing Yoga" Program, which will be created within the scope of the research, on getting children aged 5-6 years old to sleep habits.
This study was planned in a pretest, posttest design, follow-up, randomized controlled study.
The sample of the study will consist of 36 children (18 children in the intervention group, 18 children in the control group) in the 5-6 age group in Antalya between 15 March and 15 June 2023.
The "Little Yogis Doing Yoga" Program, which was created within the scope of the research, will be applied to the children in the intervention group in two groups, two days a week, for 4 weeks, 30 minutes each, by the researcher who received child yoga specialization training.
Data will be collected with Child and Family Information Form and Child Sleep Habits Questionnaire-CSHQ). CSHQ, T0-Pretest (Before the Program "Little Yogis Doing Yoga"), T1-Interim follow-up (after the program ends) and T2-Posttest (1 month after the program is completed) will be filled by the parents.
Statistical Package for the Social Sciences (SPSS) 24.0 package program will be used in the analysis of the data.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Preschool (three-six years) is a period in which the physical, psychomotor, social-emotional, cognitive and language development of the child is completed to a large extent.
In this period when the growth-development process is very important, healthy and regular sleep plays an active role in many developmental areas of children, especially in brain development.
For this reason, examining and arranging the sleep habits of children in the preschool period is of great importance for the healthy completion of the process.
The aim of this study is to determine the sleep habits of children in the 5-6 age group and to determine the effect of children's yoga on these habits.
This study was planned to determine the effect of the "Little Yogis Doing Yoga" Program, which will be created within the scope of the research, on instilling sleep habits in children aged 5-6 years.
Study Type
Interventional
Enrollment (Anticipated)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Aysegul I Dalgic, Prof.
- Phone Number: 02423106124
- Email: aisler@akdeniz.edu.tr
Study Contact Backup
- Name: Fatma Nur Ünver, RN
- Phone Number: 05079706574
- Email: unvernur16@gmail.com
Study Locations
-
-
Konyaaltı
-
Antalya, Konyaaltı, Turkey, 07058
- Recruiting
- Aysegul ISLER DALGIC
-
Contact:
- Aysegul ISLER DALGIC, Prof. Dr.
- Phone Number: 6124 +90 242 310 6103
- Email: aisler@akdeniz.edu.tr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 5-6 years old
- No school attendance problems
- Those who have the cognitive ability to carry out the commands given during child yoga.
- Having no physical problems that may prevent active participation in children's yoga
- Children who do not have an obstacle to communication (sight, hearing problems, etc.) and whose parents' consent to participate in the study are approved
Exclusion Criteria:
- Children who are actively attending any children's yoga program
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Yoga Group
The "Little Yogis Doing Yoga" Program was started to be implemented by the researcher for 4 weeks, 2 days a week for 30 minutes, separately for each group, in a way to form 2 groups.
|
The children's yoga consists of compositions such as playing, stories, postures, breathing exercises, imitations things in nature, memory games, music, dance and daydreaming.
|
|
No Intervention: Control Group
Children in the control group will continue their routine education at school.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Children's Sleep Habits Questionnaire (CSHQ)
Time Frame: CSHQ score will evaluate at baseline
|
To gain children the ability to sleep habits.
The Children's Sleep Habits Questionnaire (CSHQ)- Abbreviated Form developed by Owens et al. consists of 33 items in total.
In the scale, bedtime resistance (1,3,4,5,6,8 items), delay in falling asleep (2nd item), sleep duration (9,10,11 items), sleep anxiety (5,7,8, 21st items), night awakenings (items 16,24,25), parasomnias (12,13,14,15,17,22,23), disruption of breathing during sleep (items 18,19,20), day Eight subscales were defined as sleepiness (items 26,27,28,29,30,31,32,33).
A total of 41 points is considered the cutoff point, and values above this are considered 'clinically significant'.
|
CSHQ score will evaluate at baseline
|
|
Children's Sleep Habits Questionnaire (CSHQ)
Time Frame: CSHQ score will evaluate one month later
|
To gain children the ability to sleep habits.
The Children's Sleep Habits Questionnaire (CSHQ)- Abbreviated Form developed by Owens et al. consists of 33 items in total.
In the scale, bedtime resistance (1,3,4,5,6,8 items), delay in falling asleep (2nd item), sleep duration (9,10,11 items), sleep anxiety (5,7,8, 21st items), night awakenings (items 16,24,25), parasomnias (12,13,14,15,17,22,23), disruption of breathing during sleep (items 18,19,20), day Eight subscales were defined as sleepiness (items 26,27,28,29,30,31,32,33).
A total of 41 points is considered the cutoff point, and values above this are considered 'clinically significant'.
|
CSHQ score will evaluate one month later
|
|
Children's Sleep Habits Questionnaire (CSHQ)
Time Frame: CSHQ score will evaluate two month later
|
To gain children the ability to sleep habits.
The Children's Sleep Habits Questionnaire (CSHQ)- Abbreviated Form developed by Owens et al. consists of 33 items in total.
In the scale, bedtime resistance (1,3,4,5,6,8 items), delay in falling asleep (2nd item), sleep duration (9,10,11 items), sleep anxiety (5,7,8, 21st items), night awakenings (items 16,24,25), parasomnias (12,13,14,15,17,22,23), disruption of breathing during sleep (items 18,19,20), day Eight subscales were defined as sleepiness (items 26,27,28,29,30,31,32,33).
A total of 41 points is considered the cutoff point, and values above this are considered 'clinically significant'.
|
CSHQ score will evaluate two month later
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Fatma Nur Ünver, RN, Akdeniz University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 31, 2023
Primary Completion (Anticipated)
May 1, 2023
Study Completion (Anticipated)
June 1, 2023
Study Registration Dates
First Submitted
April 12, 2023
First Submitted That Met QC Criteria
April 12, 2023
First Posted (Actual)
April 25, 2023
Study Record Updates
Last Update Posted (Actual)
April 28, 2023
Last Update Submitted That Met QC Criteria
April 27, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- KAEK-34
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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