Yoga for Chronic Headache in Adolescents

Study Overview
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Brief Summary
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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.

Official Title
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Randomisierte Kontrollierte Studie Zur Wirkung Von Yoga Bei Chronischen Kopfschmerzen im Jugendalter

Conditions
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Tension Type Headache, Migraine

Intervention / Treatment
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* Behavioral: Yoga for adolescents
* Behavioral: Yoga for parents


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: adolescent yoga / parent control<br>The adolescent will receive an 12 week yoga course, while one parent will only answer the questionnaires. | Behavioral: Yoga for adolescents<br>* 12 week hatha yoga course for adolescents<br>|
| Experimental: adolescent waitlist / parent yoga<br>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<br>* 12 week hatha yoga course<br>|
| Experimental: adolescent yoga / parent yoga<br>Both adolescent and parent will participate in an 12 week yoga course at the same time. | Behavioral: Yoga for adolescents<br>* 12 week hatha yoga course for adolescents<br>Behavioral: Yoga for parents<br>* 12 week hatha yoga course<br>|
| No Intervention: adolescent waitlist / parent control<br>The adolescent will receive the intervention after the follow-up period, while one parent will only answer the questionnaires. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain frequency adolescent | Measurement of pain frequency after yoga intervention via headache diary | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain frequency adolescent | Measurement of pain frequency after follow-up period via headache diary | Week 24 | 
| Pain duration adolescent | Measurement of pain duration after yoga intervention via headache diary | Week 12 | 
| Pain duration adolescent | Measurement of pain duration after follow-up period via headache diary | Week 24 | 
| Pain intensity adolescent | Measurement of pain intensity after yoga intervention via headache diary | Week 12 | 
| Pain intensity adolescent | Measurement of pain intensity after follow-up period via headache diary | Week 24 | 
| Quality of life adolescent self-assessment | Measurement of quality of life in self-assessment after yoga intervention via the kidscreen 27 questionnaire | Week 12 | 
| Quality of life adolescent self-assessment | Measurement of quality of life in self-assessment after follow-up period via the kidscreen 27 questionnaire | Week 24 | 
| Quality of life adolescent external assessment | Measurement of quality of life in external assessment by one parent after yoga intervention via the kidscreen 27 questionnaire | Week 12 | 
| Quality of life adolescent external assessment | Measurement of quality of life in external assessment by one parent after follow-up period via the kidscreen 27 questionnaire | Week 24 | 
| Pain disability adolescent self-assessment | Measurement of pain disability in self-assessment after yoga intervention via the paediatric pain disability index (P-PDI) | Week 12 | 
| Pain disability adolescent self-assessment | Measurement of pain disability in self-assessment after follow-up period via the paediatric pain disability index (P-PDI) | Week 24 | 
| Pain disability adolescent external assessment | Measurement of pain disability in external assessment by one parent after yoga intervention via the paediatric pain disability index (P-PDI) | Week 12 | 
| Pain disability adolescent external assessment | Measurement of pain disability in external assessment by one parent after follow-up period via the paediatric pain disability index (P-PDI) | Week 24 | 
| Pain coping adolescent | Measurement of pain coping in self-assessment after yoga intervention via the Paediatric Pain Coping Inventory Revise (PPCI-R) | Week 12 | 
| Pain coping adolescent | Measurement of pain coping in self-assessment after follow-up period via the Paediatric Pain Coping Inventory Revise (PPCI-R) | Week 24 | 
| Depression adolescent | Measurement of Depression in self-assessment after yoga intervention via the Depressions Inventar für Kinder und Jugendliche (DIKJ) | Week 12 | 
| Depression adolescent | Measurement of Depression in self-assessment after follow-up period via the Depressions Inventar für Kinder und Jugendliche (DIKJ) | Week 24 | 
| Stress adolescent | Measurement of Stress in self-assessment after yoga intervention via the Problem Questionnaire (PQ) | Week 12 | 
| Stress adolescent | Measurement of Stress in self-assessment after follow-up period via the Problem Questionnaire (PQ) | Week 24 | 
| Pain catastrophizing parents | Measurement of parents pain catastrophizing in self-assessment by one parent after follow-up period via the Pain Catastrophizing Scale for Parents (PCS-P) | Week 12 | 
| Pain catastrophizing parents | Measurement of parents pain catastrophizing in self-assessment by one parent after follow-up period via the Pain Catastrophizing Scale for Parents (PCS-P) | Week 24 | 
| Quality of life parents | 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) | Week 12 | 
| Quality of life parents | 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) | Week 24 | 
| Depression parents | Measurement of parents depression in self-assessment by one parent after yoga intervention via the Beck-Depression-Inventar (BDI) | Week 12 | 
| Depression parents | Measurement of parents depression in self-assessment by one parent after follow-up period via the Beck-Depression-Inventar (BDI) | Week 24 | 
| Stress parents | Measurement of parents stress in self-assessment by one parent after yoga intervention via the Cohen's Perceived Stress Scale (PSS-10) | Week 12 | 
| Stress parents | Measurement of parents stress in self-assessment by one parent after follow-up period via the Cohen's Perceived Stress Scale (PSS-10) | Week 24 | 
| Adverse events adolescent | Adverse events within the yoga course period of adolescents | Week 12 | 
| Adverse events parents | Adverse events within the yoga course period of parents | Week 12 |