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

September 28, 2022 updated by: Andreas Michalsen, Charite University, Berlin, Germany

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

250

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 Locations

  • Germany
      • Berlin, Germany, 14109
        • Charite University

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

6 years to 12 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control group
ACTIVE_COMPARATOR: YoBEKA Intervention
Behavioral: YoBEKA
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Questionnaire on the assessment of stress and stress management in childhood and adolescence - Revision (SSKJ 3-8 R)
Time Frame: Change baseline, 4 months
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
Change baseline, 4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inventory of the quality of life of children and adolescents (KIDSCREEN-27 children)
Time Frame: Change Baseline, 4 months, 12 months
Filled out by students, assessing full scale, range 27-135, lower score meaning a better outcome
Change Baseline, 4 months, 12 months
Perceived Stress Scale (PSS)
Time Frame: Change Baseline, 4 months, 12 months
Filled out by teachers, assessing full scale, range 0-40, lower score meaning a better outcome
Change Baseline, 4 months, 12 months
Teacher anxiety and stress inventory (LASI)
Time Frame: Change Baseline, 4 months, 12 months
Filled out by teachers, assessing LASI 2, range 46-230, higher score meaning a better outcome
Change Baseline, 4 months, 12 months
Screening for somatoform disorders of childhood and adolescence (SOMS-E)
Time Frame: Change Baseline, 4 months, 12 months
Filled out by parents, assessing full scale, range 55-110, lower score meaning a better outcome
Change Baseline, 4 months, 12 months
Inventory of the quality of life of children and adolescents (KIDSCREEN-52 parents)
Time Frame: Change Baseline, 4 months, 12 months
Filled out by parents, assessing full scale, range 27-135, lower score meaning a better outcome
Change Baseline, 4 months, 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate variability
Time Frame: Baseline, 4 months, 12 months
Assessed with Faros 180 over 24 hours
Baseline, 4 months, 12 months
Qualitative interviews
Time Frame: 4 months, 12 months
Semi-structured interviews in focus groups
4 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

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 (ACTUAL)

January 21, 2019

Primary Completion (ACTUAL)

February 15, 2020

Study Completion (ACTUAL)

February 15, 2020

Study Registration Dates

First Submitted

January 2, 2019

First Submitted That Met QC Criteria

January 7, 2019

First Posted (ACTUAL)

January 8, 2019

Study Record Updates

Last Update Posted (ACTUAL)

September 29, 2022

Last Update Submitted That Met QC Criteria

September 28, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YoBEKA

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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