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YoBEKA Program (Yoga, Movement, Relaxation, Concentration and Mindfulness) in Elementary Schools

Primary Purpose

Stress, Psychological

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

YoBEKA

About this trial

This is an interventional prevention trial for Stress, Psychological

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion criteria:

Students from participating primary schools in Berlin aged 6-12 years
Written declaration of consent of the parent or legal guardian

Exclusion criteria:

Serious chronic or acute diseases
Immobility or serious restriction for gymnastic exercises due to orthopaedic, neurological or other medical causes
Participation in another study

Sites / Locations

Charite University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

YoBEKA Intervention

Control group

Arm Description

Outcomes

Primary Outcome Measures

Questionnaire on the assessment of stress and stress management in childhood and adolescence - Revision (SSKJ 3-8 R)

Filled out by students, assessing composite score (range 29-94): subscale 1 (stress-vulnerability [range 7-28]) summed with subscale 3 (stress symptoms and well-being [range 22-66]), lower score meaning a better outcome

Secondary Outcome Measures

Inventory of the quality of life of children and adolescents (KIDSCREEN-27 children)

Filled out by students, assessing full scale, range 27-135, lower score meaning a better outcome

Perceived Stress Scale (PSS)

Filled out by teachers, assessing full scale, range 0-40, lower score meaning a better outcome

Teacher anxiety and stress inventory (LASI)

Filled out by teachers, assessing LASI 2, range 46-230, higher score meaning a better outcome

Screening for somatoform disorders of childhood and adolescence (SOMS-E)

Filled out by parents, assessing full scale, range 55-110, lower score meaning a better outcome

Inventory of the quality of life of children and adolescents (KIDSCREEN-52 parents)

Filled out by parents, assessing full scale, range 27-135, lower score meaning a better outcome

Full Information

NCT ID

NCT03796754

First Posted

January 2, 2019

Last Updated

September 28, 2022

Sponsor

Charite University, Berlin, Germany

1. Study Identification

Unique Protocol Identification Number

NCT03796754

Brief Title

YoBEKA Program (Yoga, Movement, Relaxation, Concentration and Mindfulness) in Elementary Schools

Official Title

Integration of the YoBEKA Program (Yoga, Movement, Relaxation, Concentration and Mindfulness) Into Elementary Schools in Germany

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Completed

Study Start Date

January 21, 2019 (Actual)

Primary Completion Date

February 15, 2020 (Actual)

Study Completion Date

February 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Charite University, Berlin, Germany

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

The aim of this study is a first evaluation of the effectiveness of the YoBEKA Program (Yoga, Movement, Relaxation, Concentration and Mindfulness) to evaluate potential effects in stress reduction and concomitant psychological parameters.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stress, Psychological

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Non-Randomized

Enrollment

250 (Actual)

8. Arms, Groups, and Interventions

Arm Title

YoBEKA Intervention

Arm Type

Active Comparator

Arm Title

Control group

Arm Type

No Intervention

Intervention Type

Behavioral

Intervention Name(s)

YoBEKA

Intervention Description

The teachers and students of the YoBEKA study arm receive a guided YoBEKA practice from an experienced YoBEKA trainer during the regular 4 month intervention period. The YoBEKA program is based on a combination of different, easy to perform exercises appropriate to the school situation, consisting of postures, verses for speech, song and movement, affirmations in movement to promote balance and coordination, and various rest and silence exercises to promote body awareness and relaxation techniques. The teaching is ideologically neutral and without religious background. The participating teachers receive an initial two-hour YoBEKA introductory course. Every 2 weeks there is a one to two-hour training course. The pedagogical specialists are supported once a week by an experienced YoBEKA trainer. The teachers are encouraged to integrate the learned exercises independently and regularly into their everyday school life.

Primary Outcome Measure Information:

Title

Questionnaire on the assessment of stress and stress management in childhood and adolescence - Revision (SSKJ 3-8 R)

Description

Time Frame

Change baseline, 4 months

Secondary Outcome Measure Information:

Title

Inventory of the quality of life of children and adolescents (KIDSCREEN-27 children)

Description

Filled out by students, assessing full scale, range 27-135, lower score meaning a better outcome

Time Frame