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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03796754
Other study ID # YoBEKA
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 21, 2019
Est. completion date February 15, 2020

Study information

Verified date September 2022
Source Charite University, Berlin, Germany
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 250
Est. completion date February 15, 2020
Est. primary completion date February 15, 2020
Accepts healthy volunteers No
Gender All
Age group 6 Years to 12 Years
Eligibility 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 Design


Related Conditions & MeSH terms


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.

Locations

Country Name City State
Germany Charite University Berlin

Sponsors (1)

Lead Sponsor Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Other Heart rate variability Assessed with Faros 180 over 24 hours Baseline, 4 months, 12 months
Other Qualitative interviews Semi-structured interviews in focus groups 4 months, 12 months
Primary 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 Change baseline, 4 months
Secondary 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 Change Baseline, 4 months, 12 months
Secondary Perceived Stress Scale (PSS) Filled out by teachers, assessing full scale, range 0-40, lower score meaning a better outcome Change Baseline, 4 months, 12 months
Secondary Teacher anxiety and stress inventory (LASI) Filled out by teachers, assessing LASI 2, range 46-230, higher score meaning a better outcome Change Baseline, 4 months, 12 months
Secondary 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 Change Baseline, 4 months, 12 months
Secondary 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 Change Baseline, 4 months, 12 months
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