Evaluation of Yoga for the Treatment of Pediatric Headaches

April 6, 2015 updated by: Keri Hainsworth, Medical College of Wisconsin
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Children's Hospital of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 13-17 years
  • patient seen in the headache clinic at Children's Hospital of Wisconsin

Exclusion Criteria:

  • neck, spinal, or back injuries

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
8 weeks of Yoga, followed by 8 weeks of follow-up
Other: 8 weeks of Iyengar Yoga
Participants will attend 8 weekly, 75 min. yoga sessions, followed by 8 weeks of follow-up (will provide headache frequency/intensity)
Other: 8 weeks of Iyengar Yoga
Participants will provide headache frequency/intensity for 8 weeks, followed by 8 weekly, 75 min. yoga sessions
Active Comparator: 2
8 weeks of follow-up, followed by 8 weeks of yoga
Other: 8 weeks of Iyengar Yoga
Participants will attend 8 weekly, 75 min. yoga sessions, followed by 8 weeks of follow-up (will provide headache frequency/intensity)
Other: 8 weeks of Iyengar Yoga
Participants will provide headache frequency/intensity for 8 weeks, followed by 8 weekly, 75 min. yoga sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Headache Pain
Time Frame: Pre; Post; Weekly
Pre; Post; Weekly

Secondary Outcome Measures

Outcome Measure
Time Frame
Yoga Attendance
Time Frame: weekly
weekly

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical College of Wisconsin

Collaborators

Children's Hospital and Health System Foundation, Wisconsin
Santosh Yoga LLC

Investigators

  • Principal Investigator: Keri R Hainsworth, Ph.D., Medical College of Wisconsin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

July 30, 2008

First Submitted That Met QC Criteria

July 30, 2008

First Posted (Estimate)

August 1, 2008

Study Record Updates

Last Update Posted (Estimate)

April 7, 2015

Last Update Submitted That Met QC Criteria

April 6, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 85067-3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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