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

• ClinicalTrials.gov Identifier: NCT03796754
• Recruitment Status: Active, not recruiting
• First Posted: January 8, 2019
• Last Update Posted: February 2, 2021
• Sponsor: Charite University, Berlin, Germany
• Information provided by (Responsible Party): Andreas Michalsen, Charite University, Berlin, Germany

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.

Condition or disease	Intervention/treatment	Phase
Stress, Psychological	Behavioral: YoBEKA	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 250 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Integration of the YoBEKA Program (Yoga, Movement, Relaxation, Concentration and Mindfulness) Into Elementary Schools in Germany
• Actual Study Start Date: January 21, 2019
• Actual Primary Completion Date: February 15, 2020
• Estimated Study Completion Date: December 31, 2022

Arms and Interventions

Arm	Intervention/treatment
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.
No Intervention: Control group

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. 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
2. 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
3. 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
4. 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
5. 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

Other Outcome Measures:

1. Heart rate variability [ Time Frame: Baseline, 4 months, 12 months ]
   Assessed with Faros 180 over 24 hours
2. Qualitative interviews [ Time Frame: 4 months, 12 months ]
   Semi-structured interviews in focus groups

Eligibility Criteria

• Ages Eligible for Study: 6 Years to 12 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Germany

Charite University

Berlin, Germany, 14109

Sponsors and Collaborators

Charite University, Berlin, Germany

More Information

• Responsible Party: Andreas Michalsen, Principal Investigator, Charite University, Berlin, Germany
• ClinicalTrials.gov Identifier: NCT03796754
• Other Study ID Numbers: YoBEKA
• First Posted: January 8, 2019
• Last Update Posted: February 2, 2021
• Last Verified: February 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Stress, Psychological; Behavioral Symptoms