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Evaluation of Yoga for the Treatment of Pediatric Headaches

Primary Purpose

Headache

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

8 weeks of Iyengar Yoga

About this trial

This is an interventional treatment trial for Headache focused on measuring Headache, Complementary and Alternative Medicine, Pediatric, Yoga

Eligibility Criteria

13 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

neck, spinal, or back injuries

Sites / Locations

Children's Hospital of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Arm Description

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

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

Outcomes

Primary Outcome Measures

Headache Pain

Secondary Outcome Measures

Yoga Attendance

Full Information

NCT ID

NCT00726843

First Posted

July 30, 2008

Last Updated

April 6, 2015

Sponsor

Medical College of Wisconsin

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT00726843

Brief Title

Evaluation of Yoga for the Treatment of Pediatric Headaches

Official Title

Evaluation of Yoga for the Treatment of Pediatric Headaches

Study Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Terminated

Why Stopped

Enrollment proceeded too slowly to conduct study as RCT.

Study Start Date

July 2008 (undefined)

Primary Completion Date

December 2008 (Actual)

Study Completion Date

December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical College of Wisconsin

Collaborators

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

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Headache

Keywords

Headache, Complementary and Alternative Medicine, Pediatric, Yoga

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

7 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

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

Arm Title

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

8 weeks of Iyengar Yoga

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

8 weeks of Iyengar Yoga

Intervention Description

Participants will provide headache frequency/intensity for 8 weeks, followed by 8 weekly, 75 min. yoga sessions

Primary Outcome Measure Information:

Title

Headache Pain

Time Frame

Pre; Post; Weekly

Secondary Outcome Measure Information:

Title

Yoga Attendance

Time Frame

weekly

10. Eligibility

Sex

All

Minimum Age & Unit of Time

13 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Keri R Hainsworth, Ph.D.

Organizational Affiliation

Medical College of Wisconsin

Official's Role

Principal Investigator

Facility Information:

Facility Name

Children's Hospital of Wisconsin

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53226

Country

United States

12. IPD Sharing Statement

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Evaluation of Yoga for the Treatment of Pediatric Headaches

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