YogaNCT05828290
The Effect of Yoga on Gaining Sleep Habits in Children
A study testing Child Yoga in people with Yoga and Preschool Children, run by Akdeniz University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 5 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Yoga, Preschool Children, Sleep Habit
- What is being tested?
- Child Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Mar 2023to Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Children who are actively attending any children's yoga program
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Aysegul ISLER DALGIC
Antalya, Konyaaltı, 07058
Aysegul ISLER DALGIC, Prof. Dr., +90 242 310 6103 ext. 6124, aisler@akdeniz.edu.tr
About this study
Official title: 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.
Read the 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.
- Conditions
- Yoga, Preschool Children, Sleep Habit
- Being tested
- Child Yoga
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Child YogaBehavioural
The children's yoga consists of compositions such as playing, stories, postures, breathing exercises, imitations things in nature, memory games, music, dance and daydreaming.
| Study group | Role | What they receive |
|---|---|---|
| Yoga Group | Experimental | 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. Receives: Behavioral: Child Yoga |
| Control Group | No intervention | Children in the control group will continue their routine education at school. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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'.
Measured: CSHQ score will evaluate at baseline
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'.
Measured: CSHQ score will evaluate one month later
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'.
Measured: CSHQ score will evaluate two month later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start31 Mar 2023
- Primary completionMay 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for YogaStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- pretest, posttest design, follow-up, randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşegül İşler Dalgıç, Akdeniz University
- Investigators
- Fatma Nur Ünver, RN, Study chair, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05828290
- Sponsor's protocol ID
- KAEK-34
- Status last verified
- Apr 2023
- First submitted
- 12 Apr 2023
- Last updated
- 28 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Little Yogis do Yoga Program on Sleeping Habits in Pre-school Children: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05828290
- Acronym / sponsor ID
- KAEK-34
- Conditions
- Yoga, Preschool Children, Sleep Habit
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 31 Mar 2023 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 25 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- pretest, posttest design, follow-up, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Yoga Group | Experimental | Behavioral: Child YogaThe "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. |
| Control Group | No intervention | –Children in the control group will continue their routine education at school. |
Who may qualify
- Ages
- 5 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Children who are actively attending any children's yoga program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Child YogaThe children's yoga consists of compositions such as playing, stories, postures, breathing exercises, imitations things in nature, memory games, music, dance and daydreaming. | Behavioural | Yoga Group |
Primary outcome
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'.
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'.
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'.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2023.
- Individual participant dataSharing planned: No
Related trials for Yoga
Recruiting
Yoga vs. Stretching-Strengthening: Physical Fitness in Sedentary Young Adults
Sedentary Lifestlye, Exercise
Not yet recruiting
Mind-Body Chair Yoga for Functional Mobility in Individuals With Lipedema
Lipedema
Recruiting
Trauma-Informed Yoga Intervention in Young Women
Trauma, Young Adult Females
Recruiting
Prenatal Yoga Intervention in Pregnant Women
Pregnant Women, Prenatal Yoga
Not yet recruiting
Integrated Core Stability Exercises and Yoga Program on Premenstrual Syndrome
Premenstrual Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fatma Nur Ünver, RN study chair
Akdeniz University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Child Yoga in people with Yoga and Preschool Children, run by Akdeniz University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aysegul I Dalgic, Prof. (02423106124, aisler@akdeniz.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children's Sleep Habits Questionnaire (CSHQ) (time frame: CSHQ score will evaluate at baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2023.