- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05891691
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
Not yet recruiting
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Estimated)
68
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: Gökçe Algül, Lecturer
- Phone Number: 03122026510
- Email: gokcealgul@gazi.edu.tr
Study Contact Backup
- Name: Ebru Kılıçarslan Törüner, Professor
- Phone Number: 0 312 216 29 03
- Email: ebrutoruner@gazi.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:
- 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 |
Intervention / Treatment |
|---|---|
|
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.
|
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
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
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
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)
October 1, 2023
Primary Completion (Estimated)
December 1, 2023
Study Completion (Estimated)
March 1, 2024
Study Registration Dates
First Submitted
May 18, 2023
First Submitted That Met QC Criteria
May 26, 2023
First Posted (Actual)
June 7, 2023
Study Record Updates
Last Update Posted (Actual)
June 7, 2023
Last Update Submitted That Met QC Criteria
May 26, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Other Study ID 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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