PreschoolNCT05891691
THE EFFECTS OF THE YOGA-BASED PROGRAM ON THE SOCIAL EMOTIONAL AND PSYCHOLOGICAL HEALTH OF CHILDREN, SOCIAL SKILLS AND QUALITY OF LIFE
A study testing Music Activities, Yoga, Massage in people with Preschool and Yoga, run by Gazi University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 to 72 monthsHealthy volunteers can take part
- What is being tested?
- Music Activities, Yoga, Massage
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2023to 1 Mar 2024
- 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 60 to 72 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- She has a contraindication such as heart disease, wilms tumor that would prevent her from doing massage and yoga
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Preschool, Yoga, Massage, Psychological Well-Being, Quality of Life
- Being tested
- Music Activities, Yoga, Massage
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music Activities, Yoga, MassageBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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. Receives: Behavioral: Music Activities, Yoga, Massage |
| Control Group | No intervention | The teachers will continue their education within the program they have prepared. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social Emotional Wellbeing and Psychological Resilience Scale for Preschool Children
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.
Measured: Baseline, after the six week intervention.
Social Competence and Behavior Evaluation SCBE-30
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.
Measured: Baseline, after the six week intervention.
The Pediatric Quality of Life Inventory (PedsQL) (5-7 years)
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.
Measured: Baseline, after the six week intervention.
Secondary outcomes (4)
Qualitative Data on the Feasibility of Yoga Intervention Using Focus Group Discussions with Children
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.
Measured: After six weeks
Program Attendance Form
Will assess the number of school-based sessions each child attends to assess commitment to the program.
Measured: During the six-week intervention, before yoga-based practice classes
Self-Assessment Form for Children
A visual analog scale will be used to measure each child's satisfaction and comfort levels in the intervention group.
Measured: During the six-week intervention, after yoga-based practice classes
Parent and Child Descriptive Data Form
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start1 Oct 2023 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreschoolStudies of the same condition, open and under way.
- More trials run by Gazi 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gökçe Algül, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05891691
- Sponsor's protocol ID
- Gazi University-GokceAlgul-001
- Status last verified
- May 2023
- First submitted
- 18 May 2023
- Last updated
- 7 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05891691
- Acronym / sponsor ID
- Gazi University-GokceAlgul-001
- Conditions
- Preschool, Yoga, Massage, Psychological Well-Being, Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 7 Jun 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 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.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Music Activities, Yoga, MassageIn 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. |
| Control Group | No intervention | –The teachers will continue their education within the program they have prepared. |
Who may qualify
- Ages
- 60 to 72 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- She has a contraindication such as heart disease, wilms tumor that would prevent her from doing massage and yoga
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 |
|---|---|---|
| Music Activities, Yoga, MassageThe 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. | Behavioural | Intervention Group |
Primary outcome
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.
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.
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.
4 secondary outcomes
Qualitative Data on the Feasibility of Yoga Intervention Using Focus Group Discussions with Children
Time frame: After six weeks
Program Attendance Form
Time frame: 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
Parent and Child Descriptive Data Form
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Music Activities, Yoga, Massage in people with Preschool and Yoga, run by Gazi University.
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 6 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 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Gökçe Algül, Lecturer (03122026510, gokcealgul@gazi.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social Emotional Wellbeing and Psychological Resilience Scale for Preschool Children (time frame: Baseline, after the six week intervention.). 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 7 Jun 2023.