Mind-Body Balance for Pediatric Migraine
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen byScott Powers, PhD
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Children's Hospital Medical Center, Cincinnati
Must be taking: Nutraceuticals, Anti-migraine
Disqualifiers: Continuous migraine, Severe psychiatric disease, others
No Placebo Group
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.
12345Is 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.
35678How 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.
12346Eligibility 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.
+2 more
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.
+2 more
Trial 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
Participant Groups
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.
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.
20 minute session is already approved in United States for the following indications:
🇺🇸 Approved in United States as Mind Body Balance for:
- Pediatric Migraine
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Cincinnati Children's Hospital Medical CenterCincinnati, OH
University of Colorado/Children's Hospital ColoradoAurora, CO
Loading ...
Who Is Running the Clinical Trial?
Children's Hospital Medical Center, CincinnatiLead Sponsor
National Center for Complementary and Integrative Health (NCCIH)Collaborator
References
Mind-Body Therapies in Children and Youth. [2018]Mind-body therapies are popular and are ranked among the top 10 complementary and integrative medicine practices reportedly used by adults and children in the 2007-2012 National Health Interview Survey. A growing body of evidence supports the effectiveness and safety of mind-body therapies in 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 and practices, including biofeedback, clinical hypnosis, guided imagery, meditation, and yoga. The report is intended to help health care professionals guide their patients to nonpharmacologic approaches to improve concentration, help decrease pain, control discomfort, or ease anxiety.
Mind-Body Medicine in Pediatrics. [2020]The primary goals of this Special Issue are to encourage readers to become more familiar with the range of mind-body therapies and to explore their application in the pediatric clinical setting. The Special Issue includes a deliberate mix of case studies and practical clinical guidance, with the dual goals of piquing curiosity and providing resources for clinicians interested in pursuing further training.
A school-based, nurse-administered relaxation training for children with chronic tension-type headache. [2019]Compared the efficacy of a school-based, nurse-administered relaxation training intervention to a no-treatment control condition for children (10-15 years old) with chronic tension-type headache and the outcome at posttreatment and a 6-month follow-up. The study was conducted in a controlled between-group design including 26 schoolchildren who were randomly assigned to the two treatment conditions. Results showed that headache activity in the children treated with relaxation training was significantly more reduced than among those in the no-treatment control group at posttreatment as well as the 6-month follow-up. At these evaluations, 69% and 73% of the pupils, respectively, treated with relaxation had achieved a clinically significant headache improvement (at least a 50% improvement) as compared to 8% and 27% of the pupils, respectively, in the no-treatment control group. Thus, a school-based, nurse-administered relaxation training program seems to be a viable treatment approach for children with chronic tension-type headaches.
Perspectives on Technology-Assisted Relaxation Approaches to Support Mind-Body Skills Practice in Children and Teens: Clinical Experience and Commentary. [2020]It has been well-established that a variety of mind-body (MB) techniques, including yoga, mental imagery, hypnosis, biofeedback, and meditation, are effective at addressing symptoms such as pain, anxiety, nausea, and insomnia, as well as helping with a wide variety of medical, emotional, and behavioral issues in pediatric populations. In addition, MB skills can also be health promoting in the long-term, and with regular practice, could potentially contribute to longer attention spans, social skills, emotional regulation, and enhanced immune system functioning. Importantly, the benefits accrued from MB skills are largely dose dependent, meaning that individuals who practice with some consistency tend to benefit the most, both in the short- and long-term. However, clinical experience suggests that for busy patients, the regular practice of MB skills can be challenging and treatment adherence commonly becomes an issue. This commentary reviews the concept of technology assisted relaxation as an engaging and effective option to enhance treatment adherence (i.e., daily practice) for pediatric patients, for whom MB skills have been recommended to address physical and mental health challenges.
[Relaxation and biofeedback in the treatment of chronic headache in children and adolescents. A status report.]. [2021]The first studies on psychological treatment of pediatric headache appeared about 10 years ago; most of them were published in Anglo-American journals. This review focuses on relaxation training and biofeedback (EMG and hand temperature feedback) as the psychological interventions most often used in pediatric migraine and tension headaches. The results of randomized group studies, which were mostly well-controlled, on the efficacy of relaxation therapy (n=12) now allow a rather optimistic prognosis on the feasibility of this intervention. Most studies demonstrate clinically relevant reductions of headache frequency after training. Biofeedback studies are methodologically less well controlled and although positive effects have been observed, e.g., in single case studies, the relative usefulness of biofeedback has yet to be determined. Deficits in research on the psychological treatment of headache in children and adolescents are described, new research issues are discussed and recommendations for more systematic research are given.
Biofeedback and relaxation-response training in the treatment of pediatric migraine. [2019]To assess the efficacy of electromyographic biofeedback, relaxation-response training and pain behavior management as a treatment for pediatric migraine, we studied 18 children between the ages of eight and 12 years (mean = 10 X 1) in a prospective, randomized, controlled investigation. Six patients received all three treatment procedures, six received relaxation-response training and pain behavior management, and the remaining six constituted a waiting-list control group. All patients kept a record of their headaches for the 15-week study period and then for four weeks one year later. Following four weeks of baseline, the treatment groups completed nine one-hour treatment sessions in 11 weeks. Both treatment groups experienced a significant reduction in headache symptoms and were significantly improved compared to the waiting-list control group by the end of treatment. The treatment groups did not differ from each other in any of these comparisons. The reduction in headache symptoms in the treatment groups was maintained one year after treatment ended. These results suggest that relaxation-response training, with or without biofeedback training, combined with pain behavior management, is an effective alternative treatment for pediatric migraine.
Relaxation treatment administered by school nurses to adolescents with recurrent headaches. [2009]To study the outcome of two different forms of relaxation training administered by school nurses to adolescents suffering from recurrent headaches in an effectiveness study.
Treatment of childhood migraine with autogenic training and skin temperature biofeedback: a component analysis. [2019]Using a controlled group outcome design, skin temperature biofeedback with autogenic training and autogenic training only was compared to a waiting list as a treatment for childhood headache. Thirty children with migraine headaches, ages 7 to 18 years were randomly assigned to one of the three conditions. Statistical analyses of headache activity indicated that children in the treatment groups improved in headache frequency and duration but not intensity as compared to the waiting list control group. These findings were consistent through a 6 month follow-up. In terms of clinical improvement, 80% of the biofeedback group, 50% of the autogenics group, and none of the waiting list control group were symptom-free. These findings were discussed in relation to past childhood headache studies and implications for current treatment of children with headaches.