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Mind-Body Balance for Pediatric Migraine

N/A

Recruiting

Led By Scott Powers, PhD

Research Sponsored by Children's Hospital Medical Center, Cincinnati

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

PedMIDAS: PedMIDAS Disability Score > 4 and < 140, indicating at least mild disruption in daily activities and extreme disability that may require more comprehensive, multi-component therapy

Diagnosis: Migraine with or without aura or chronic migraine that meets the International Classification of Headache Disorders (ICHD) criteria

Must not have

Continuous migraine defined as unrelenting headache for a 28 day period

PedMIDAS Disability Score > 140, indicating extreme disability that may require more comprehensive, multi-component therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to post treatment (8 weeks post randomization)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a mind-body intervention delivered by a nurse, using different doses of three treatment components, to find the combination that works best to reduce the number of headache days.

Who is the study for?

This trial is for English-speaking individuals with migraines, experiencing 4 to 28 headache days per month. They should have a mild to severe impact on daily life but not be extremely disabled. Participants must be on stable migraine medication if used and agree not to overuse certain painkillers.

What is being tested?

The study tests a nurse-led mind-body intervention for reducing headache days in pediatric patients. It explores different combinations of treatment components: sessions lasting either 40 or 20 minutes, e-health home practice, handouts, and phone calls.

What are the potential side effects?

Since the interventions are non-medical (mind-body techniques), side effects may include discomfort during practice or increased awareness of symptoms initially; however, significant medical side effects are unlikely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My daily activities are mildly to extremely disrupted due to my condition.

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I have been diagnosed with migraine, following international headache guidelines.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a headache non-stop for 28 days.

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My migraine disability score is over 140, showing I have extreme disability.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to post treatment (8 weeks post randomization)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to post treatment (8 weeks post randomization)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to post treatment (8 weeks post randomization) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in number of headache days

Secondary study objectives

Change in absolute headache disability score on PedMIDAS

Other study objectives

Feasibility and adherence to the home practice component

Feasibility and adherence to the phone call component

Feasibility and adherence to the session time component

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

8Treatment groups

Experimental Treatment

Group I: 40 minute session, home practice handout, phone callExperimental Treatment3 Interventions

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.

Group II: 40 minute session, home practice handout, no phone callExperimental Treatment2 Interventions

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.

Group III: 40 minute session, home practice e-health, phone callExperimental Treatment3 Interventions

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.

Group IV: 40 minute session, home practice e-health, no phone callExperimental Treatment2 Interventions

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.

Group V: 20 minute session, home practice handout, phone callExperimental Treatment3 Interventions

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.

Group VI: 20 minute session, home practice handout, no phone callExperimental Treatment2 Interventions

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.

Group VII: 20 minute session, home practice e-health, phone callExperimental Treatment3 Interventions

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.

Group VIII: 20 minute session, home practice e-health, no phone callExperimental Treatment2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

phone call

2017

N/A

~290

0 / 4Eligibility criteria met