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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

Tracking Information
First Submitted Date  ICMJE March 17, 2016
First Posted Date  ICMJE March 29, 2016
Last Update Posted Date July 26, 2017
Actual Study Start Date  ICMJE April 2016
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 22, 2016)
Pain frequency adolescent [ Time Frame: Week 12 ]
Measurement of pain frequency after yoga intervention via headache diary
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 22, 2016)
  • Pain frequency adolescent [ Time Frame: Week 24 ]
    Measurement of pain frequency after follow-up period via headache diary
  • Pain duration adolescent [ Time Frame: Week 12 ]
    Measurement of pain duration after yoga intervention via headache diary
  • Pain duration adolescent [ Time Frame: Week 24 ]
    Measurement of pain duration after follow-up period via headache diary
  • Pain intensity adolescent [ Time Frame: Week 12 ]
    Measurement of pain intensity after yoga intervention via headache diary
  • Pain intensity adolescent [ Time Frame: Week 24 ]
    Measurement of pain intensity after follow-up period via headache diary
  • 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
  • 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
  • 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
  • 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
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • Depression adolescent [ Time Frame: Week 12 ]
    Measurement of Depression in self-assessment after yoga intervention via the Depressions Inventar für Kinder und Jugendliche (DIKJ)
  • 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)
  • Stress adolescent [ Time Frame: Week 12 ]
    Measurement of Stress in self-assessment after yoga intervention via the Problem Questionnaire (PQ)
  • Stress adolescent [ Time Frame: Week 24 ]
    Measurement of Stress in self-assessment after follow-up period via the Problem Questionnaire (PQ)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • Adverse events adolescent [ Time Frame: Week 12 ]
    Adverse events within the yoga course period of adolescents
  • Adverse events parents [ Time Frame: Week 12 ]
    Adverse events within the yoga course period of parents
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Yoga for Chronic Headache in Adolescents
Official Title  ICMJE Randomisierte Kontrollierte Studie Zur Wirkung Von Yoga Bei Chronischen Kopfschmerzen im Jugendalter
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Tension Type Headache
  • Migraine
Intervention  ICMJE
  • Behavioral: Yoga for adolescents
    12 week hatha yoga course for adolescents
  • Behavioral: Yoga for parents
    12 week hatha yoga course
Study Arms  ICMJE
  • Experimental: adolescent yoga / parent control
    The adolescent will receive an 12 week yoga course, while one parent will only answer the questionnaires.
    Intervention: Behavioral: Yoga 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.
    Intervention: Behavioral: Yoga for parents
  • Experimental: adolescent yoga / parent yoga
    Both adolescent and parent will participate in an 12 week yoga course at the same time.
    Interventions:
    • Behavioral: Yoga for adolescents
    • Behavioral: Yoga for parents
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 24, 2017)
45
Original Estimated Enrollment  ICMJE
 (submitted: March 22, 2016)
80
Actual Study Completion Date  ICMJE July 2017
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02721849
Other Study ID Numbers  ICMJE 15-6736
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Holger Cramer, Universität Duisburg-Essen
Study Sponsor  ICMJE Universität Duisburg-Essen
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Universität Duisburg-Essen
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP