Yoga for Chronic Headache in Adolescents

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

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.

Study Overview

• Status: Completed
• Conditions: Migraine; Tension Type Headache
• Intervention / Treatment: Behavioral: Yoga for adolescents; Behavioral: Yoga for parents

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Essen, Germany
    • Elisabeth Krankenhaus
  • Landshut, Germany
    • Kinderkrankenhaus St. Marien

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universität Duisburg-Essen

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: March 17, 2016
• First Submitted That Met QC Criteria: March 22, 2016
• First Posted (Estimate): March 29, 2016

Study Record Updates

• Last Update Posted (Actual): July 26, 2017
• Last Update Submitted That Met QC Criteria: July 24, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Headache; Tension-Type Headache
• Other Study ID Numbers: 15-6736

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No