NCT00726843

Brief Summary

This study will examine the feasibility and acceptability of yoga for adolescents seen by a medical practitioner for their headaches. The study will also examine whether yoga decreases anxiety and improves quality of life. We hypothesize that yoga will be both acceptable and feasible with a pediatric population. We also hypothesize that yoga will decrease anxiety and improve quality of life.

Trial Health

57
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Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2008

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

July 30, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 1, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

April 7, 2015

Status Verified

April 1, 2015

Enrollment Period

5 months

First QC Date

July 30, 2008

Last Update Submit

April 6, 2015

Conditions

Headache

Keywords

HeadacheComplementary and Alternative MedicinePediatricYoga

Outcome Measures

Primary Outcomes (1)

  • Headache Pain

    Pre; Post; Weekly

Secondary Outcomes (1)

  • Yoga Attendance

    weekly

Study Arms (2)

1

ACTIVE COMPARATOR

8 weeks of Yoga, followed by 8 weeks of follow-up

Other: 8 weeks of Iyengar Yoga

2

ACTIVE COMPARATOR

8 weeks of follow-up, followed by 8 weeks of yoga

Other: 8 weeks of Iyengar Yoga

Interventions

8 weeks of Iyengar YogaOTHER

Participants will attend 8 weekly, 75 min. yoga sessions, followed by 8 weeks of follow-up (will provide headache frequency/intensity)

1

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • years
  • patient seen in the headache clinic at Children's Hospital of Wisconsin

You may not qualify if:

  • neck, spinal, or back injuries

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Headache

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Keri R Hainsworth, Ph.D.

    Medical College of Wisconsin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 30, 2008

First Posted

August 1, 2008

Study Start

July 1, 2008

Primary Completion

December 1, 2008

Study Completion

December 1, 2009

Last Updated

April 7, 2015

Record last verified: 2015-04

Locations

US(1)