NCT05891691

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 7, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

June 7, 2023

Status Verified

May 1, 2023

Enrollment Period

2 months

First QC Date

May 18, 2023

Last Update Submit

May 26, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    Baseline, after the six week intervention.

Secondary Outcomes (4)

  • Qualitative Data on the Feasibility of Yoga Intervention Using Focus Group Discussions with Children

    After six weeks

  • Program Attendance Form

    During the six-week intervention, before yoga-based practice classes

  • Self-Assessment Form for Children

    During the six-week intervention, after yoga-based practice classes

  • Parent and Child Descriptive Data Form

    Baseline

Study Arms (2)

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.

Behavioral: Music Activities, Yoga, Massage

Control Group

NO INTERVENTION

The teachers will continue their education within the program they have prepared.

Interventions

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.

Intervention Group

Eligibility Criteria

Age60 Months - 72 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Psychological Well-Being

Interventions

YogaMassage

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy ModalitiesTherapy, Soft TissueMusculoskeletal ManipulationsRehabilitation

Central Study Contacts

Gökçe Algül, Lecturer

CONTACT

Ebru Kılıçarslan Törüner, Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

May 18, 2023

First Posted

June 7, 2023

Study Start

October 1, 2023

Primary Completion

December 1, 2023

Study Completion

March 1, 2024

Last Updated

June 7, 2023

Record last verified: 2023-05