Mind-Body Balance for Pediatric Migraine

Recruiting at 1 trial location

Overseen By LeighAnn Chamberlin, MEd

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital Medical Center, Cincinnati

Must be taking: Nutraceuticals, Anti-migraine

Disqualifiers: Continuous migraine, Severe psychiatric disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 8 weeks

260 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find the best way to help kids and teens reduce migraine headaches using mind-body skills. Participants will try different combinations of short or long sessions (20-minute or 40-minute sessions) and will either use an online portal or a handout at home, with some receiving follow-up phone calls. Kids or teens who experience migraines at least four times a month and are already using certain migraine medications or supplements might be a good fit.

As an unphased trial, this study offers a unique opportunity for participants to explore innovative approaches to managing migraines.

Do I need to stop my current medications to join the trial?

You can continue taking your current prescribed nutraceuticals and preventive anti-migraine medications during the study, as long as you are on a stable dose. However, you should not take non-specific acute medications like ibuprofen more than 3 times a week or migraine-specific medications like triptans more than 6 times a month.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research on similar mind-body treatments, such as relaxation training and biofeedback, shows they are generally safe for children. These methods can help reduce headaches and are usually well-tolerated. Various studies report few serious side effects. The focus on teaching coping skills typically doesn't cause harm.

Mind-body therapies have been used with children and teenagers in many settings and maintain a good safety record. These treatments are non-invasive, meaning they don't involve surgery or medication, which reduces risks.

Overall, evidence suggests that mind-body balance sessions, whether 20 or 40 minutes long, should be safe. Participants mainly engage in activities like focused breathing or relaxation exercises, making them a low-risk option for managing pediatric migraines. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these migraine management techniques because they focus on mind-body skills, which offer a unique approach compared to traditional medications. Unlike standard treatments that often rely on drugs like triptans and beta-blockers, these methods involve short introductory sessions and daily home practices using either an interactive online portal or a handout. Another standout feature is the personalized follow-up phone calls for some participants, designed to boost adherence to the practice routine. This holistic approach is being explored for its potential to empower children to manage their migraines more effectively without medication.

What evidence suggests that this trial's treatments could be effective for pediatric migraine?

Research has shown that mind-body therapies, such as relaxation training, can significantly reduce headaches in children. This trial will explore various mind-body balance interventions, including 20-minute and 40-minute sessions, combined with home practice components and optional follow-up phone calls. One study found that a relaxation program at school reduced headache activity by more than half in children with chronic tension headaches. Another review found that techniques like progressive muscle relaxation reduced the number of headache days by over 50% for half of the participants. Although the quality of evidence varies, these findings suggest that mind-body methods might effectively manage migraines in children. ^{1 2 5 6 7}

Who Is on the Research Team?

Scott Powers, PhD

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

Language: English speaking, able to complete interviews and questionnaires in English

I have headaches between 4 to 28 days in a month.

Exclusion Criteria

Pregnancy in youth, or sexually active individuals not using a medically accepted form of contraception

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

I agree to limit my use of pain and migraine medications as required.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a mind body skill introduction session and engage in home practice for headache management, with some receiving follow-up phone calls

8 weeks

1 session (in-person), ongoing home practice

Follow-up

Participants are monitored for changes in headache days and adherence to intervention components

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 20 minute session
• 40 minute session
• home practice e-health
• home practice handout
• phone call

Trial Overview 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.

How Is the Trial Designed?

Group I: 40 minute session, home practice handout, phone call Experimental Treatment 3 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 call Experimental Treatment 2 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 call Experimental Treatment 3 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 call Experimental Treatment 2 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 call Experimental Treatment 3 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 call Experimental Treatment 2 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 call Experimental Treatment 3 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 call Experimental Treatment 2 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.

20 minute session is already approved in United States for the following indications:

Approved in United States as Mind Body Balance for:

• Pediatric Migraine

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials

844

Recruited

6,566,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Published Research Related to This Trial

In a study involving 30 children aged 7 to 18 with migraine headaches, both skin temperature biofeedback combined with autogenic training and autogenic training alone significantly reduced headache frequency and duration compared to a waiting list control group.

After 6 months, 80% of children in the biofeedback group were symptom-free, compared to 50% in the autogenic training group and none in the control group, highlighting the effectiveness of biofeedback as a treatment for childhood headaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of childhood migraine with autogenic training and skin temperature biofeedback: a component analysis. Labbé, EE.[2019]

Mind-body therapies, such as biofeedback, clinical hypnosis, guided imagery, meditation, and yoga, are widely used by both adults and children, and there is increasing evidence supporting their effectiveness and safety in pediatric care.

These therapies can serve as valuable nonpharmacologic options for healthcare professionals to help children improve concentration, reduce pain, manage discomfort, and alleviate anxiety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mind-Body Therapies in Children and Youth. [2018]

A school-based, nurse-administered relaxation training program significantly reduced headache activity in children aged 10-15 with chronic tension-type headaches compared to a no-treatment control group, with improvements observed at both posttreatment and 6-month follow-up.

At the follow-up, 73% of children who received relaxation training reported a clinically significant improvement in their headaches (at least a 50% reduction), compared to only 27% in the control group, highlighting the efficacy of this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A school-based, nurse-administered relaxation training for children with chronic tension-type headache. Larsson, B., Carlsson, J.[2019]

Relaxation training has shown promising results in reducing the frequency of pediatric migraines and tension headaches, with 12 well-controlled studies supporting its efficacy.

Biofeedback techniques, while showing some positive effects in individual cases, lack robust methodological support, and further research is needed to clarify their effectiveness compared to relaxation training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Relaxation and biofeedback in the treatment of chronic headache in children and adolescents. A status report.]. Kröner-Herwig, B., Ehlert, U.[2021]

In a study of 18 children aged 8 to 12, both electromyographic biofeedback combined with relaxation-response training and pain behavior management significantly reduced migraine symptoms compared to a waiting-list control group over a 15-week period.

The benefits of the treatments were sustained for up to one year after the sessions ended, indicating that these methods are effective long-term alternatives for managing pediatric migraines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biofeedback and relaxation-response training in the treatment of pediatric migraine. Fentress, DW., Masek, BJ., Mehegan, JE., et al.[2019]

Mind-body techniques like yoga and meditation are effective in treating various symptoms such as pain and anxiety in children, and they can promote long-term health benefits like improved attention and emotional regulation.

Regular practice of these techniques is crucial for maximizing benefits, but adherence can be difficult for busy patients; technology-assisted relaxation may help improve consistency in practice among pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perspectives on Technology-Assisted Relaxation Approaches to Support Mind-Body Skills Practice in Children and Teens: Clinical Experience and Commentary. Culbert, T.[2020]

This Special Issue aims to enhance understanding of various mind-body therapies and their potential use in pediatric healthcare settings.

It combines case studies with practical guidance to inspire clinicians and provide resources for further training in these therapeutic approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mind-Body Medicine in Pediatrics. McClafferty, H.[2020]

Relaxation training administered by school nurses showed some effectiveness in reducing headache activity and increasing headache-free days in adolescents, but did not significantly outperform a control group of untreated subjects.

Only 19% of treated adolescents experienced at least a 50% improvement in their headaches, suggesting that the current training for school nurses may not be sufficient for achieving significant clinical outcomes, and further training is needed before implementing this as a standard treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relaxation treatment administered by school nurses to adolescents with recurrent headaches. Fichtel, A., Larsson, B.[2009]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6462122/

Relaxation training for management of paediatric headache The quality of evidence on the effectiveness of relaxation training for paediatric headaches across all outcomes was very low.

2. withpower.com withpower.com/trial/phase-migraine-without-aura-2-2021-75b1d

Mind-Body Balance for Pediatric Migraine A school-based, nurse-administered relaxation training program significantly reduced headache activity in children aged 10-15 with chronic tension-type ...

3. aafp.org aafp.org/pubs/afp/issues/2007/1115/p1518.html

Mind-Body Therapies for Headache High effect sizes (more than 50 percent headache reduction) were found in patients with migraine and tension headaches compared with control ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8807374/

Psychological Interventions for Pediatric Headache Disorders This review summarizes key findings from recent investigations of psychological interventions for pediatric headache disorders and discusses important avenues ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/ene.16414

Behavioral therapy in migraine: Expanding the therapeutic ... Mind–body techniques with progressive muscle relaxation exercises were also studied, with a reduction of >50% in headache days in 50% of the ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04715685/mind-body-balance-for-pediatric-migraine?activelyRecruiting=false&page=803&id=45&slug=chronic-pain

Mind Body Balance for Pediatric Migraine This study uses a factorial research design to evaluate a nurse delivered mind body intervention using different doses of 3 treatment components ...

7. publications.aap.org publications.aap.org/pediatrics/article/138/3/e20161896/52650/Mind-Body-Therapies-in-Children-and-Youth

Mind-Body Therapies in Children and Youth | Pediatrics This clinical report outlines popular mind-body therapies for children and youth and examines the best-available evidence for a variety of mind-body therapies ...