A Preliminary Investigation of the Efficacy of Aromatherapy in Reducing Discomfort in Youth With Chronic Headache
Completed · Not applicable
Conditions studied: Chronic Headache, Migraine Headache, Headache
In brief
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.
Key facts
- Study ID
- NCT02440997
- Run by
- Children's Mercy Hospital Kansas City
- People needed
- 46
- Starts
- 2015-03-25
- Expected to finish
- 2017-01-04
- Last updated by the study team
- 2017-04-10
Who can join
Age: 7 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- • 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
You may not qualify if…
- • 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
Where it is running
- Children's Mercy Hospital — Kansas City, Missouri, United States
Full record on ClinicalTrials.gov
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