Mind Body Balance for Pediatric Migraine

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Children's Hospital Medical Center, Cincinnati
Study ID
NCT04715685
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
10 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • 40 minute session — BEHAVIORAL
    The 40 minute session will include all of the content contained in the 20 minute session, but will include a greater explanation of each of the mind and body skills, followed by in vivo practice of each skill with the nurse. Sessions will also include review of home practice for each group.
  • 20 minute session — BEHAVIORAL
    For participants randomized to the 20 minute session, content will include pain education, followed by brief explanations of each of the mind and body skills, in vivo diaphragmatic breathing practice and demonstration of use of biofeedback card. Sessions will also include review of home practice for each group.
  • home practice e-health — BEHAVIORAL
    Participants will be provided and instructed on access to a migraine-specific interactive web portal, Migraine e-Health. This web-based tool actively guides participants in practicing evidence-based mind and body skills. Use of the Migraine -e-Health application for the high dose capitalizes on teaching participants mind and body skills while increasing accessibility due to implementation on mobile devices.
  • home practice handout — BEHAVIORAL
    Participants will be given a handout of commercially available free apps relevant to the mind body skills introduced.
  • phone call — BEHAVIORAL
    The dose of phone call will occur about 4 weeks following the face-to-face mind and body introduction session and will last approximately 5-10 minutes. The phone call will be used to promote adherence to home-practice and answer questions related to skill use/home practice completion.

Study Details

This study uses a factorial research design to evaluate a nurse delivered mind body intervention using different doses of 3 treatment components to determine the optimized treatment for headache day reduction.

Key Dates

Start date
Mar 9, 2021
Status verified
Mar 2026
Primary completion
May 1, 2026
Completion
May 31, 2026

Study Design

Enrollment
260 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Experimental: 40 minute session, home practice e-health, phone call
    This intervention arm consists of mind body skill introduction session that is 40 minutes in duration. The daily home practice component for headache management will utilize a migraine specific interactive web portal, Migraine e-health portal. This arm will also receive a follow up phone call 4 weeks after the introductory session to promote adherence to home practice.
  • Experimental: 40 minute session, home practice e-health, no phone call
    This intervention arm consists of mind body skill introduction session that is 40 minutes in duration. The daily home practice component for headache management will utilize a migraine specific interactive web portal, Migraine e-health portal. This arm will not receive a follow up phone call 4 weeks after the introductory session to promote adherence to home practice.
  • Experimental: 40 minute session, home practice handout, phone call
    This intervention arm consists of mind body skill introduction session that is 40 minutes in duration. The daily home practice component for headache management will utilize a handout with explanations of mind body skills and a home practice plan. This arm will also receive a follow up phone call 4 weeks after the introductory session to promote adherence to home practice.
  • Experimental: 40 minute session, home practice handout, no phone call
    This intervention arm consists of mind body skill introduction session that is 40 minutes in duration. The daily home practice component for headache management will utilize a handout with explanations of mind body skills and a home practice plan. This arm will not receive a follow up phone call 4 weeks after the introductory session to promote adherence to home practice.
  • Experimental: 20 minute session, home practice e-health, phone call
    This intervention arm consists of mind body skill introduction session that is 20 minutes in duration. The daily home practice component for headache management will utilize a migraine specific interactive web portal, Migraine e-health portal. This arm will also receive a follow up phone call 4 weeks after the introductory session to promote adherence to home practice.
  • Experimental: 20 minute session, home practice e-health, no phone call
    This intervention arm consists of mind body skill introduction session that is 20 minutes in duration. The daily home practice component for headache management will utilize a migraine specific interactive web portal, Migraine e-health portal. This arm will not receive a follow up phone call 4 weeks after the introductory session to promote adherence to home practice.
  • Experimental: 20 minute session, home practice handout, phone call
    This intervention arm consists of mind body skill introduction session that is 20 minutes in duration. The daily home practice component for headache management will utilize a handout with explanations of mind body skills and a home practice plan. This arm will also receive a follow up phone call 4 weeks after the introductory session to promote adherence to home practice.
  • Experimental: 20 minute session, home practice handout, no phone call
    This intervention arm consists of mind body skill introduction session that is 20 minutes in duration. The daily home practice component for headache management will utilize a handout with explanations of mind body skills and a home practice plan. This arm will not receive a follow up phone call 4 weeks after the introductory session to promote adherence to home practice.

Primary Outcome Measure

Change in number of headache days [ Time Frame: baseline to post treatment (8 weeks post randomization) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Colorado/Children's Hospital ColoradoAuroraColorado80045-
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229
Leigh Ann Chamberlin
[email protected]
513-636-9737

Find similar trials in Aurora, CO

By condition
Migraine
By specialty
Neurology
By research site
University of Colorado/Children's Hospital Colorado· Aurora, COCincinnati Children's Hospital Medical Center· Cincinnati, OH

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