THE EFFECTS OF THE YOGA-BASED PROGRAM ON THE SOCIAL EMOTIONAL AND PSYCHOLOGICAL HEALTH OF CHILDREN, SOCIAL SKILLS AND QUALITY OF LIFE

May 26, 2023 updated by: Gökçe Algül, Gazi University

THE EFFECTS OF A PROGRAM OF MOVING MUSIC ACTIVITIES, YOGA AND MASSAGE ON HEALTHY PRESCHOOL CHILDREN'S SOCIAL EMOTIONAL WELL-BEING AND PSYCHOLOGICAL RESILIENCE, SOCIAL SKILLS AND QUALITY OF LIFE

This study was planned to evaluate the effectiveness of a yoga-based psychosocial development program developed in line with the literature to improve the social, emotional and behavioral skills and quality of life of healthy preschool children. Watson's Human Care Model constitutes the theoretical framework of the study. The sample of the study, which will be conducted in a quasi-experimental design with a pre-test-post-test control group, consists of healthy children aged 60-72 months. The g*power 3.1.9.4 program was used to determine the sample size and it was determined that there should be at least 34 people in each group. The program consists of moving music activities, yoga postures accompanied by stories, breathing techniques and self-massage practices. The program will be implemented by the researcher, who has received specialty training in child yoga, for 30 minutes a day, two days a week for 6 weeks. Data will be collected using the Parent and Child Descriptive Data Form, Program Participation Form, Child Self-Assessment Form, Social Emotional Well-Being and Psychological Resilience Scale for Preschool Children, Social Competence and Behavior Rating Scale-30 and Pediatric Quality of Life Inventory. As a result of this study, positive effects are expected on the social, emotional, behavioral skills and quality of life of children to whom the psychosocial development program is applied.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet 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 years are a critical period in which children acquire physical, mental, emotional and social skills and development progresses rapidly. Psychosocial skills are one of the most important dimensions of development. It is emphasized that there is an important relationship between psychosocial skills and health and well-being. It is reported that socially competent and social-emotionally developed children are better able to cope with stressful situations, this skill increases school readiness, academic self-efficacy and academic success, and improves peer relations and coping skills with emotions. In the literature, school-based intervention programs that facilitate children's coping with stress, enable them to respond constructively to psychological and social difficulties, and help them develop emotion regulation skills are recommended from preschool onwards. The aim of this study was to determine the effects of a psychosocial development program that includes moving music activities, exercises including yoga postures accompanied by stories, breathing techniques and self-massage practices on social-emotional well-being and psychological resilience, social competence, behavior and quality of life of preschool children.

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 (Estimated)

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.
68

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

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:

  • 60-72 months
  • Do not have a health problem that would prevent them from actively participating in group games (attention deficit, hyperactivity, down syndrome, autism, etc.)
  • Who have not participated in a similar program before
  • Speak and understand Turkish
  • Volunteer to participate in the program
  • Children whose parents gave consent to participate in the study.

Exclusion Criteria:

  • She has a contraindication such as heart disease, wilms tumor that would prevent her from doing massage and yoga

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: Non-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: Intervention Group
In addition to the training program prepared by the classroom teacher, the initiative group will receive a program that includes music activities, yoga postures accompanied by stories, breathing techniques and massage exercises, 2 days a week, 30 minutes a day for 6 weeks.
Behavioral: Music Activities, Yoga, Massage
The program begins with music and dance movements using percussion instruments (rhythm stick, stone triangle, drum, cymbal, tambourine, maracas, etc.) and body percussion. In this phase, the children will follow the instructions of the researcher. The goal is to warm up the bodies and musically experience the beginning of the program After the warm-up, yoga postures are combined with breathing techniques that focus on developing awareness of body sensations and feelings.The daily program ends with massage. During the massage application, the children sit in a circle. The massage is performed by the children observing the movements of the researcher on their arms and legs and applying them on their own arms and legs.Yoga postures, breathing techniques, and massage practices are accompanied by stories to ensure children's active participation, encourage their development, and facilitate their acquisition of new approaches.
No Intervention: Control Group
The teachers will continue their education within the program they have prepared.

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
Social Emotional Wellbeing and Psychological Resilience Scale for Preschool Children
Time Frame: Baseline, after the six week intervention.
A 36 item scale validated with six sub-scales: Communicating / Social Performance, Self-Control / Thoughtfulness, Assertiveness, Emotional Stability / Coping with Stress, Task Orientation, Enjoyment of Exploration. The scale will be completed by teachers on behalf of the children to screen and monitor the response to the intervention.
Baseline, after the six week intervention.
Social Competence and Behavior Evaluation SCBE-30
Time Frame: Baseline, after the six week intervention.
A 30 item scale validated with three sub-scales: Competence, Anger-Aggression, and Anxiety-Introversion, with ten items in each dimension.The scale will be completed by teachers on behalf of the children to screen and monitor the response to the intervention.
Baseline, after the six week intervention.
The Pediatric Quality of Life Inventory (PedsQL) (5-7 years)
Time Frame: Baseline, after the six week intervention.
It consists of 23 items questioning physical and psychosocial (emotional, social and school functionality) functionality. The scale will be completed by parents on behalf of the children to screen and monitor the response to the intervention.
Baseline, after the six week intervention.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Qualitative Data on the Feasibility of Yoga Intervention Using Focus Group Discussions with Children
Time Frame: After six weeks
At the end of 6 weeks, a semi-structured qualitative interview will be conducted with a simple random method with 10 randomly selected children from the intervention group to evaluate the program. Children will be asked what they liked most and least about the program, what they learned from yoga, their favorite poses in yoga, how breathing exercises felt. Interviews with the children will be held in a quiet, uninterrupted, school-owned area to be directed by the school administration. In order for the children to feel more comfortable, the children will be interviewed in groups of two or three.
After six weeks
Program Attendance Form
Time Frame: During the six-week intervention, before yoga-based practice classes
Will assess the number of school-based sessions each child attends to assess commitment to the program.
During the six-week intervention, before yoga-based practice classes
Self-Assessment Form for Children
Time Frame: During the six-week intervention, after yoga-based practice classes
A visual analog scale will be used to measure each child's satisfaction and comfort levels in the intervention group.
During the six-week intervention, after yoga-based practice classes
Parent and Child Descriptive Data Form
Time Frame: Baseline
A total of 12 questions (age, sex, education level, monthly income, etc.) were asked about the child and parent's identifying information. The descriptive characteristics form was developed by the researchers based on the literature
Baseline

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.
Gazi 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 (Estimated)

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.
October 1, 2023

Primary Completion (Estimated)

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.
December 1, 2023

Study Completion (Estimated)

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.
March 1, 2024

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).
May 18, 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.
May 26, 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.
June 7, 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.
June 7, 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.
May 26, 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.
May 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.
  • Gazi University-GokceAlgul-001

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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