Evaluation of Yoga for the Treatment of Pediatric Headaches

This study has been terminated.

( Enrollment proceeded too slowly to conduct study as RCT. )

First Received on July 30, 2008. Last Updated on September 3, 2010 History of Changes

Sponsor:	Medical College of Wisconsin
Collaborators:	Children's Hospital and Health System Foundation, Wisconsin Santosh Yoga LLC
Information provided by:	Medical College of Wisconsin
ClinicalTrials.gov Identifier:	NCT00726843

Purpose

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.

Condition	Intervention
Headache	Other: 8 weeks of Iyengar Yoga

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Evaluation of Yoga for the Treatment of Pediatric Headaches

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Headache

U.S. FDA Resources

Further study details as provided by Medical College of Wisconsin:

Primary Outcome Measures:

Headache Pain [ Time Frame: Pre; Post; Weekly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Yoga Attendance [ Time Frame: weekly ] [ Designated as safety issue: No ]

Enrollment:	7
Study Start Date:	July 2008
Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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)
Active Comparator: 2 8 weeks of follow-up, followed by 8 weeks of yoga	Other: 8 weeks of Iyengar Yoga Participants will provide headache frequency/intensity for 8 weeks, followed by 8 weekly, 75 min. yoga sessions

Eligibility

Ages Eligible for Study:	13 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

neck, spinal, or back injuries

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00726843

Locations

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

Sponsors and Collaborators

Medical College of Wisconsin

Children's Hospital and Health System Foundation, Wisconsin

Santosh Yoga LLC

Investigators

Principal Investigator:

Keri R Hainsworth, Ph.D.

Medical College of Wisconsin

More Information

No publications provided

Responsible Party:	Keri R. Hainsworth, PhD, Research Psychologist, Medical College of Wisconsin
ClinicalTrials.gov Identifier:	NCT00726843 History of Changes
Other Study ID Numbers:	85067-3
Study First Received:	July 30, 2008
Last Updated:	September 3, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by Medical College of Wisconsin:

Headache
Complementary and Alternative Medicine
Pediatric
Yoga

Additional relevant MeSH terms:

Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on February 09, 2012