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Yoga for Chronic Headache in Adolescents

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ClinicalTrials.gov Identifier: NCT02721849
Recruitment Status : Completed
First Posted : March 29, 2016
Last Update Posted : July 26, 2017
Sponsor:
Information provided by (Responsible Party):
Holger Cramer, Universität Duisburg-Essen

Brief Summary:
A randomized controlled trial to investigate the efficacy of yoga on tension type headache and / or migraine in adolescents between 12 and 16 years, consisting of a four group design which includes an 12 week yoga course and a three-month follow-up period. Both adolescent and one parent will be randomized either to yoga or no treatment. Primary outcome will be pain frequency in adolescents considering pain catastrophizing of parents.

Condition or disease Intervention/treatment Phase
Tension Type Headache Migraine Behavioral: Yoga for adolescents Behavioral: Yoga for parents Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomisierte Kontrollierte Studie Zur Wirkung Von Yoga Bei Chronischen Kopfschmerzen im Jugendalter
Actual Study Start Date : April 2016
Actual Primary Completion Date : March 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Headache

Arm Intervention/treatment
Experimental: adolescent yoga / parent control
The adolescent will receive an 12 week yoga course, while one parent will only answer the questionnaires.
Behavioral: Yoga for adolescents
12 week hatha yoga course for adolescents

Experimental: adolescent waitlist / parent yoga
One parent will participate in an 12 week yoga course, while the adolescent will receive the intervention after the follow-up period.
Behavioral: Yoga for parents
12 week hatha yoga course

Experimental: adolescent yoga / parent yoga
Both adolescent and parent will participate in an 12 week yoga course at the same time.
Behavioral: Yoga for adolescents
12 week hatha yoga course for adolescents

Behavioral: Yoga for parents
12 week hatha yoga course

No Intervention: adolescent waitlist / parent control
The adolescent will receive the intervention after the follow-up period, while one parent will only answer the questionnaires.



Primary Outcome Measures :
  1. Pain frequency adolescent [ Time Frame: Week 12 ]
    Measurement of pain frequency after yoga intervention via headache diary


Secondary Outcome Measures :
  1. Pain frequency adolescent [ Time Frame: Week 24 ]
    Measurement of pain frequency after follow-up period via headache diary

  2. Pain duration adolescent [ Time Frame: Week 12 ]
    Measurement of pain duration after yoga intervention via headache diary

  3. Pain duration adolescent [ Time Frame: Week 24 ]
    Measurement of pain duration after follow-up period via headache diary

  4. Pain intensity adolescent [ Time Frame: Week 12 ]
    Measurement of pain intensity after yoga intervention via headache diary

  5. Pain intensity adolescent [ Time Frame: Week 24 ]
    Measurement of pain intensity after follow-up period via headache diary

  6. Quality of life adolescent self-assessment [ Time Frame: Week 12 ]
    Measurement of quality of life in self-assessment after yoga intervention via the kidscreen 27 questionnaire

  7. Quality of life adolescent self-assessment [ Time Frame: Week 24 ]
    Measurement of quality of life in self-assessment after follow-up period via the kidscreen 27 questionnaire

  8. Quality of life adolescent external assessment [ Time Frame: Week 12 ]
    Measurement of quality of life in external assessment by one parent after yoga intervention via the kidscreen 27 questionnaire

  9. Quality of life adolescent external assessment [ Time Frame: Week 24 ]
    Measurement of quality of life in external assessment by one parent after follow-up period via the kidscreen 27 questionnaire

  10. Pain disability adolescent self-assessment [ Time Frame: Week 12 ]
    Measurement of pain disability in self-assessment after yoga intervention via the paediatric pain disability index (P-PDI)

  11. Pain disability adolescent self-assessment [ Time Frame: Week 24 ]
    Measurement of pain disability in self-assessment after follow-up period via the paediatric pain disability index (P-PDI)

  12. Pain disability adolescent external assessment [ Time Frame: Week 12 ]
    Measurement of pain disability in external assessment by one parent after yoga intervention via the paediatric pain disability index (P-PDI)

  13. Pain disability adolescent external assessment [ Time Frame: Week 24 ]
    Measurement of pain disability in external assessment by one parent after follow-up period via the paediatric pain disability index (P-PDI)

  14. Pain coping adolescent [ Time Frame: Week 12 ]
    Measurement of pain coping in self-assessment after yoga intervention via the Paediatric Pain Coping Inventory Revise (PPCI-R)

  15. Pain coping adolescent [ Time Frame: Week 24 ]
    Measurement of pain coping in self-assessment after follow-up period via the Paediatric Pain Coping Inventory Revise (PPCI-R)

  16. Depression adolescent [ Time Frame: Week 12 ]
    Measurement of Depression in self-assessment after yoga intervention via the Depressions Inventar für Kinder und Jugendliche (DIKJ)

  17. Depression adolescent [ Time Frame: Week 24 ]
    Measurement of Depression in self-assessment after follow-up period via the Depressions Inventar für Kinder und Jugendliche (DIKJ)

  18. Stress adolescent [ Time Frame: Week 12 ]
    Measurement of Stress in self-assessment after yoga intervention via the Problem Questionnaire (PQ)

  19. Stress adolescent [ Time Frame: Week 24 ]
    Measurement of Stress in self-assessment after follow-up period via the Problem Questionnaire (PQ)

  20. Pain catastrophizing parents [ Time Frame: Week 12 ]
    Measurement of parents pain catastrophizing in self-assessment by one parent after follow-up period via the Pain Catastrophizing Scale for Parents (PCS-P)

  21. Pain catastrophizing parents [ Time Frame: Week 24 ]
    Measurement of parents pain catastrophizing in self-assessment by one parent after follow-up period via the Pain Catastrophizing Scale for Parents (PCS-P)

  22. Quality of life parents [ Time Frame: Week 12 ]
    Measurement of parents quality of life in self-assessment by one parent after yoga intervention via the WHO Quality of Life Bref questionnaire (WHOQol-Bref)

  23. Quality of life parents [ Time Frame: Week 24 ]
    Measurement of parents quality of life in self-assessment by one parent after follow-up period via the WHO Quality of Life Bref questionnaire (WHOQol-Bref)

  24. Depression parents [ Time Frame: Week 12 ]
    Measurement of parents depression in self-assessment by one parent after yoga intervention via the Beck-Depression-Inventar (BDI)

  25. Depression parents [ Time Frame: Week 24 ]
    Measurement of parents depression in self-assessment by one parent after follow-up period via the Beck-Depression-Inventar (BDI)

  26. Stress parents [ Time Frame: Week 12 ]
    Measurement of parents stress in self-assessment by one parent after yoga intervention via the Cohen's Perceived Stress Scale (PSS-10)

  27. Stress parents [ Time Frame: Week 24 ]
    Measurement of parents stress in self-assessment by one parent after follow-up period via the Cohen's Perceived Stress Scale (PSS-10)

  28. Adverse events adolescent [ Time Frame: Week 12 ]
    Adverse events within the yoga course period of adolescents

  29. Adverse events parents [ Time Frame: Week 12 ]
    Adverse events within the yoga course period of parents



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Adolescent:

  • tension type headache and/or migraine minimum at 4 days per month
  • willingness to participate at least 10 out of 12 yoga sessions
  • physical and cognitive ability to participate in light physical, breathing and relaxation exercises
  • good german language

Parents:

  • willingness to participate at least 10 out of 12 yoga sessions
  • physical and cognitive ability to participate in light physical, breathing and relaxation exercises
  • good german language

Exclusion Criteria:

  • pregnancy or lactation
  • attending a yoga class within the last 3 months prior to the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02721849


Locations
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Germany
Elisabeth Krankenhaus
Essen, Germany
Kinderkrankenhaus St. Marien
Landshut, Germany
Sponsors and Collaborators
Universität Duisburg-Essen
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Responsible Party: Holger Cramer, Research Director, Universität Duisburg-Essen
ClinicalTrials.gov Identifier: NCT02721849    
Other Study ID Numbers: 15-6736
First Posted: March 29, 2016    Key Record Dates
Last Update Posted: July 26, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Tension-Type Headache
Headache
Pain
Neurologic Manifestations
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases