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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05828290
Other study ID # KAEK-34
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 31, 2023
Est. completion date June 2023

Study information

Verified date April 2023
Source Akdeniz University
Contact Aysegul I Dalgic, Prof.
Phone 02423106124
Email aisler@akdeniz.edu.tr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 36
Est. completion date June 2023
Est. primary completion date May 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 5 Years to 6 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Child Yoga
The children's yoga consists of compositions such as playing, stories, postures, breathing exercises, imitations things in nature, memory games, music, dance and daydreaming.

Locations

Country Name City State
Turkey Aysegul ISLER DALGIC Antalya Konyaalti

Sponsors (1)

Lead Sponsor Collaborator
Akdeniz University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Children's Sleep Habits Questionnaire (CSHQ) 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
Primary Children's Sleep Habits Questionnaire (CSHQ) 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
Primary Children's Sleep Habits Questionnaire (CSHQ) 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
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