NCT02721849

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 29, 2016

Completed
3 days until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

July 26, 2017

Status Verified

July 1, 2017

Enrollment Period

11 months

First QC Date

March 17, 2016

Last Update Submit

July 24, 2017

Conditions

Tension Type HeadacheMigraine

Outcome Measures

Primary Outcomes (1)

  • Pain frequency adolescent

    Measurement of pain frequency after yoga intervention via headache diary

    Week 12

Secondary Outcomes (29)

  • Pain frequency adolescent

    Week 24

  • Pain duration adolescent

    Week 12

  • Pain duration adolescent

    Week 24

  • Pain intensity adolescent

    Week 12

  • Pain intensity adolescent

    Week 24

  • +24 more secondary outcomes

Study Arms (4)

adolescent yoga / parent control

EXPERIMENTAL

The adolescent will receive an 12 week yoga course, while one parent will only answer the questionnaires.

Behavioral: Yoga for adolescents

adolescent waitlist / parent yoga

EXPERIMENTAL

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

adolescent yoga / parent yoga

EXPERIMENTAL

Both adolescent and parent will participate in an 12 week yoga course at the same time.

Behavioral: Yoga for adolescentsBehavioral: Yoga for parents

adolescent waitlist / parent control

NO INTERVENTION

The adolescent will receive the intervention after the follow-up period, while one parent will only answer the questionnaires.

Interventions

Yoga for adolescentsBEHAVIORAL

12 week hatha yoga course for adolescents

adolescent yoga / parent controladolescent yoga / parent yoga
Yoga for parentsBEHAVIORAL

12 week hatha yoga course

adolescent waitlist / parent yogaadolescent yoga / parent yoga

Eligibility Criteria

Age12 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • pregnancy or lactation
  • attending a yoga class within the last 3 months prior to the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Elisabeth Krankenhaus

Essen, Germany

Location

Kinderkrankenhaus St. Marien

Landshut, Germany

Location

MeSH Terms

Conditions

Tension-Type HeadacheMigraine Disorders

Interventions

Yoga

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Director

Study Record Dates

First Submitted

March 17, 2016

First Posted

March 29, 2016

Study Start

April 1, 2016

Primary Completion

March 1, 2017

Study Completion

July 1, 2017

Last Updated

July 26, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

DE(2)