Yoga for Chronic Headache in Adolescents

Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02721849
• Other study ID #: 15-6736
• Status: Completed
• Phase: N/A
• First received: March 17, 2016
• Last updated: July 24, 2017
• Start date: April 2016
• Est. completion date: July 2017

Study information

• Verified date: July 2017
• Source: Universität Duisburg-Essen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: July 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Headache
• Migraine
• Tension Type Headache
• Tension-Type Headache

Intervention

Behavioral:
• Yoga for adolescents
12 week hatha yoga course for adolescents
• Yoga for parents
12 week hatha yoga course

Locations

Country	Name	City	State
Germany	Elisabeth Krankenhaus	Essen
Germany	Kinderkrankenhaus St. Marien	Landshut

Sponsors (1)

Lead Sponsor	Collaborator
Universität Duisburg-Essen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain frequency adolescent	Measurement of pain frequency after yoga intervention via headache diary	Week 12
Secondary	Pain frequency adolescent	Measurement of pain frequency after follow-up period via headache diary	Week 24
Secondary	Pain duration adolescent	Measurement of pain duration after yoga intervention via headache diary	Week 12
Secondary	Pain duration adolescent	Measurement of pain duration after follow-up period via headache diary	Week 24
Secondary	Pain intensity adolescent	Measurement of pain intensity after yoga intervention via headache diary	Week 12
Secondary	Pain intensity adolescent	Measurement of pain intensity after follow-up period via headache diary	Week 24
Secondary	Quality of life adolescent self-assessment	Measurement of quality of life in self-assessment after yoga intervention via the kidscreen 27 questionnaire	Week 12
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Pain coping adolescent	Measurement of pain coping in self-assessment after yoga intervention via the Paediatric Pain Coping Inventory Revise (PPCI-R)	Week 12
Secondary	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
Secondary	Depression adolescent	Measurement of Depression in self-assessment after yoga intervention via the Depressions Inventar für Kinder und Jugendliche (DIKJ)	Week 12
Secondary	Depression adolescent	Measurement of Depression in self-assessment after follow-up period via the Depressions Inventar für Kinder und Jugendliche (DIKJ)	Week 24
Secondary	Stress adolescent	Measurement of Stress in self-assessment after yoga intervention via the Problem Questionnaire (PQ)	Week 12
Secondary	Stress adolescent	Measurement of Stress in self-assessment after follow-up period via the Problem Questionnaire (PQ)	Week 24
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Depression parents	Measurement of parents depression in self-assessment by one parent after yoga intervention via the Beck-Depression-Inventar (BDI)	Week 12
Secondary	Depression parents	Measurement of parents depression in self-assessment by one parent after follow-up period via the Beck-Depression-Inventar (BDI)	Week 24
Secondary	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
Secondary	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
Secondary	Adverse events adolescent	Adverse events within the yoga course period of adolescents	Week 12
Secondary	Adverse events parents	Adverse events within the yoga course period of parents	Week 12