A Preliminary Investigation of the Efficacy of Aromatherapy in Reducing Discomfort in Youth With Chronic Headache
| Status: | Recruiting |
|---|---|
| Conditions: | Migraine Headaches, Migraine Headaches |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 7 - 17 |
| Updated: | 4/2/2016 |
| Start Date: | April 2015 |
| End Date: | December 2016 |
| Contact: | Rae A Kingsley, MSN, APRN |
| Email: | rakingsley@cmh.edu |
| Phone: | 816-983-6721 |
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.
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.
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.
Inclusion Criteria:
- • 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:
- • 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
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