A Preliminary Investigation of the Efficacy of Aromatherapy in Reducing Discomfort in Youth With Chronic Headache
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About
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.
Full description
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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• Male or female, children and adolescents age 7-17 years of age
- Diagnosed with status migrainosus or refractory chronic daily headache according to the International Headache Society (ICHD-II) criteria. (A debilitating migraine lasting for more than 72 hours or a headache that lasts hours or may be continuous occurring on > 15 days per month for > 3 months.)
- No prior history of aromatherapy / essential oil use
- Able to read, comprehend and complete study procedures. Capable of reading and completing all subjective measures in English
- Are sufficiently alert to be assessed and communicate
- Must be compliant with routine medical care and able to perform study-related procedures
- Provide written informed consent from parent/legal guardian and child assent in accordance with IRB regulations
Exclusion criteria
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• Known sensitivity to essential oils
- History of cardiac fibrillation
- History of G6PD deficiency
- History of uncontrolled asthma (current, active wheezing)
- History of diabetes, high blood pressure, epilepsy,
- Inflammatory or sensory limitations of lower extremities or concurrent lesions of the foot(s)
- Past or concurrent history of olfactory impairment
- Concomitant use of propanolol
- Tobacco use
- Hepatotoxicity
- Pregnancy
Trial design
Primary purpose
Allocation
Interventional model
Masking
46 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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