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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey
    • Konyaaltı
      • Antalya, Konyaaltı, Turkey, 07058
        • Recruiting
        • Aysegul ISLER DALGIC
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.
No Intervention: Control Group
Children in the control group will continue their routine education at school.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Akdeniz University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 31, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 12, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 25, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 28, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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