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

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment Mind-Body Balance for Pediatric Migraine?

Research shows that mind-body therapies, like relaxation training and biofeedback, can effectively reduce headache frequency in children. A study found that nurse-administered relaxation training significantly reduced headache activity in children with chronic tension-type headaches, suggesting similar approaches could help with pediatric migraines. ^{1 2 3 4 5}

Is Mind-Body Balance for Pediatric Migraine safe for children?

Research on similar treatments like relaxation training and biofeedback for children with headaches shows they are generally safe and can reduce headache symptoms. These methods have been used in various studies without reports of harmful effects, suggesting they are safe for children. ^{3 5 6 7 8}

How does the Mind-Body Balance treatment for pediatric migraine differ from other treatments?

The Mind-Body Balance treatment for pediatric migraine is unique because it involves mind-body therapies like relaxation training, which are non-drug approaches that help manage pain and anxiety through techniques such as meditation and guided imagery. This treatment is delivered in short sessions and can be administered by nurses, making it accessible and practical for children, especially in settings like schools. ^{1 2 3 4 6}

Research Team

Scott Powers, PhD

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

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

2. Switzerland pubmed.ncbi.nlm.nih.gov

Mind-Body Medicine in Pediatrics. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

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

4. Switzerland 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. [2020]

5. Germany pubmed.ncbi.nlm.nih.gov

[Relaxation and biofeedback in the treatment of chronic headache in children and adolescents. A status report.]. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Biofeedback and relaxation-response training in the treatment of pediatric migraine. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Relaxation treatment administered by school nurses to adolescents with recurrent headaches. [2009]

8. United States pubmed.ncbi.nlm.nih.gov

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