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Mind-Body Balance for Pediatric Migraine

Q: Is the age cap for this trial set at 85 years old?

Eligible participants for this research must be aged between 10 and 17 years.

Q: Are enrollment opportunities still open for this research project?

Affirmative. Clinicaltrials.gov shows that this investigation, which was initially posted on March 15th 2021, is actively recruiting individuals for participation. Two hundred patients from 2 sites are needed to complete the study.

Q: What sort of individuals is this trial ideally suited for?

This clinical trial looks to recruit 200 minors aged 10-17 suffering from migraines. To be eligible, they must fulfil the ICHD criteria for <a href="https://www.withpower.com/clinical-trials/migraine">migraine</a> with/without aura; have a PedMIDAS disability score between 4 and 140; use one or more of the listed preventive medications in stable doses prior to randomisation; be English-speaking and able to understand questionnaires.

Q: What is the total enrollment of this research project?

Indeed, the data on clinicaltrials.gov suggests that this investigation is currently searching for participants. The trial was initially made public on March 15th 2021 and has been refreshed as of February 7th 2022. A total of 200 candidates need to be acquired from two distinct medical facilities.

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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

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

Select...

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in number of headache days

Secondary outcome measures

Change in absolute headache disability score on PedMIDAS

Other outcome measures

Feasibility and adherence to the home practice component

Feasibility and adherence to the phone call component

Feasibility and adherence to the session time component

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor

815 Previous Clinical Trials

6,531,391 Total Patients Enrolled

6 Trials studying Migraine

2,103 Patients Enrolled for Migraine

National Center for Complementary and Integrative Health (NCCIH)NIH

832 Previous Clinical Trials

668,773 Total Patients Enrolled

11 Trials studying Migraine

1,276 Patients Enrolled for Migraine

Scott Powers, PhDPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati

3 Previous Clinical Trials

775 Total Patients Enrolled

3 Trials studying Migraine

775 Patients Enrolled for Migraine

Media Library

20 minute session Clinical Trial Eligibility Overview. Trial Name: NCT04715685 — N/A

Migraine Research Study Groups: 40 minute session, home practice e-health, phone call, 40 minute session, home practice e-health, no phone call, 40 minute session, home practice handout, phone call, 40 minute session, home practice handout, no phone call, 20 minute session, home practice e-health, phone call, 20 minute session, home practice e-health, no phone call, 20 minute session, home practice handout, phone call, 20 minute session, home practice handout, no phone call

Migraine Clinical Trial 2023: 20 minute session Highlights & Side Effects. Trial Name: NCT04715685 — N/A

20 minute session 2023 Treatment Timeline for Medical Study. Trial Name: NCT04715685 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age cap for this trial set at 85 years old?

"Eligible participants for this research must be aged between 10 and 17 years."

Answered by AI

Are enrollment opportunities still open for this research project?

"Affirmative. Clinicaltrials.gov shows that this investigation, which was initially posted on March 15th 2021, is actively recruiting individuals for participation. Two hundred patients from 2 sites are needed to complete the study."

Answered by AI

What sort of individuals is this trial ideally suited for?

"This clinical trial looks to recruit 200 minors aged 10-17 suffering from migraines. To be eligible, they must fulfil the ICHD criteria for migraine with/without aura; have a PedMIDAS disability score between 4 and 140; use one or more of the listed preventive medications in stable doses prior to randomisation; be English-speaking and able to understand questionnaires."

Answered by AI

What is the total enrollment of this research project?

"Indeed, the data on clinicaltrials.gov suggests that this investigation is currently searching for participants. The trial was initially made public on March 15th 2021 and has been refreshed as of February 7th 2022. A total of 200 candidates need to be acquired from two distinct medical facilities."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Mind Body Balance for Pediatric Migraine

2021. "Mind Body Balance for Pediatric Migraine". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04715685.

All > Chronic Daily Headache > Migraine