Yoga for Chronic Headache in Adolescents

• Sponsor: Universität Duisburg-Essen (Other)
• Overall Status: Completed
• CT.gov ID: NCT02721849
• Collaborator: (none)
• Enrollment: 45
• Locations: 2
• Arms: 4
• Actual Duration (Months): 15
• Patients Per Site: 22.5
• Patients Per Site Per Month: 1.5

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• 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: Apr 1, 2016
• Actual Primary Completion Date: Mar 1, 2017
• Actual Study Completion Date: Jul 1, 2017

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Pain frequency adolescent [Week 12]

   Measurement of pain frequency after yoga intervention via headache diary

Secondary Outcome Measures

1. Pain frequency adolescent [Week 24]

   Measurement of pain frequency after follow-up period via headache diary

2. Pain duration adolescent [Week 12]

   Measurement of pain duration after yoga intervention via headache diary

3. Pain duration adolescent [Week 24]

   Measurement of pain duration after follow-up period via headache diary

4. Pain intensity adolescent [Week 12]

   Measurement of pain intensity after yoga intervention via headache diary

5. Pain intensity adolescent [Week 24]

   Measurement of pain intensity after follow-up period via headache diary

6. Quality of life adolescent self-assessment [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [Week 12]

    Measurement of Depression in self-assessment after yoga intervention via the Depressions Inventar für Kinder und Jugendliche (DIKJ)

17. Depression adolescent [Week 24]

    Measurement of Depression in self-assessment after follow-up period via the Depressions Inventar für Kinder und Jugendliche (DIKJ)

18. Stress adolescent [Week 12]

    Measurement of Stress in self-assessment after yoga intervention via the Problem Questionnaire (PQ)

19. Stress adolescent [Week 24]

    Measurement of Stress in self-assessment after follow-up period via the Problem Questionnaire (PQ)

20. Pain catastrophizing parents [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 [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 [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 [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 [Week 12]

    Measurement of parents depression in self-assessment by one parent after yoga intervention via the Beck-Depression-Inventar (BDI)

25. Depression parents [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 [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 [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 [Week 12]

    Adverse events within the yoga course period of adolescents

29. Adverse events parents [Week 12]

    Adverse events within the yoga course period of parents

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 16 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Elisabeth Krankenhaus	Essen		Germany
2	Kinderkrankenhaus St. Marien	Landshut		Germany

Sponsors and Collaborators

• Universität Duisburg-Essen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Holger Cramer, Research Director, Universität Duisburg-Essen
• ClinicalTrials.gov Identifier: NCT02721849
• Other Study ID Numbers: 15-6736
• First Posted: Mar 29, 2016
• Last Update Posted: Jul 26, 2017
• Last Verified: Jul 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Tension-Type Headache; Headache

Study Results

No Results Posted as of Jul 26, 2017