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The purpose of this study is to preliminarily establish the extent to which a brief aromatherapy intervention incrementally improves subjective and objective indicators of discomfort (pain, anxiety, and heart rate variability) beyond passive relaxation in youth with chronic headaches. A secondary objective is to establish the safety of using aromatherapy as a treatment strategy in youth with chronic headache. The investigators hypothesize that children randomized to the aromatherapy condition will demonstrate a greater improvement in pain, anxiety, and objectively measured distress (heart rate variability) than comparable children receiving only a passive relaxation treatment (a foot bath). The investigators further hypothesize that the aromatherapy intervention will be safe and well-tolerated by study participants.
Complementary and alternative therapies play an increasing role in the multidisciplinary treatment of primary pediatric headache disorders. Every pediatric headache patient needs to have a personalized and tailored program of education, psychological strategies, pharmacotherapy and complementary medicine choices. This particular study may prove desirable for parents of children and adolescents with chronic headache. As documented by Termine, C., Ferrari, Ginevra, O., D'Arrigo, S., Rossi, M., & Lanzi, G. (2005), parents are often uncertain and fearful of submitting their children to treatment with traditional drugs, adolescents can use alternative therapies as a way of affirming their independence, and there are fewer drugs available to treat headache in children. Moreover, there is a 30-40% placebo response in headache sufferers (Mauskop, 2001). Children and adolescents should not be prevented from using alternative treatments, specifically essential oils, provided that the intervention is not harmful or costly. It is hoped this study will contribute to the scant research that exists and help define the indications, effects and limitations of aromatherapy use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| foot bath only | Placebo Comparator | 10 minute foot bath with addition of jojoba only |
|
| foot bath and aromatherapy | Experimental | 10 minute foot bath with addition of jojoba with added Mentha piperita |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aromatherapy | Other |
|
| |
| foot bath |
| Measure | Description | Time Frame |
|---|---|---|
| improvement in subjective and objective indicators of discomfort | pain and anxiety measured subjectively via VAS | 30 minutes |
| improvement in subjective and objective indicators of discomfort | heart rate variability measured -10, 10 and 20 minutes | 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| number of Adverse Events | assessment of presence or absence of Adverse Events or Serious Adverse Events | 30 minutes |
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Inclusion Criteria:
• Male or female, children and adolescents age 7-17 years of age
Exclusion Criteria:
• Known sensitivity to essential oils
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| Name | Affiliation | Role |
|---|---|---|
| Rae A Kingsley, MSN, APRN | Children's Mercy Hospital Kansas City | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Mercy Hospital | Kansas City | Missouri | 64108 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Battaiglia, S. (2003). The complete guide to aromatherapy (2nd edition). Brisbane, Australia: The International Centre of Holistic Aromatherapy | ||
| 23204398 | Background | Blume HK. Pediatric headache: a review. Pediatr Rev. 2012 Dec;33(12):562-76. doi: 10.1542/pir.33-12-562. No abstract available. | |
| 10484830 |
| Label | URL |
|---|---|
| developing and delivering research-based, practical, and reliable tools and technologies | View source |
Not provided
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| ID | Term |
|---|---|
| D020773 | Headache Disorders |
| D008881 | Migraine Disorders |
| D006261 | Headache |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D051270 | Headache Disorders, Primary |
Not provided
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| ID | Term |
|---|---|
| D019341 | Aromatherapy |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D008517 | Phytotherapy |
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| Other |
|
| Background |
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| headache classification | View source |
| Aromatherapy and Essential Oils (PDQ). National Cancer Institute at the National Institutes of Health | View source |
| Peppermint oil (Mentha x piperita L.). Natural Standard Database Web site. | View source |
| Research Randomizer ©1997-2008 by Geoffery C. Urbaniak and Scott Plous Social Psychology Network | View source |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D026421 |
| Sensory Art Therapies |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |