A Preliminary Investigation of the Efficacy of Aromatherapy in Reducing Discomfort in Youth With Chronic Headache

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Preliminary Investigation of the Efficacy of Aromatherapy in Reducing Discomfort in Youth With Chronic Headache

Conditions
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Headache, Chronic Headache, Migraine Headache

Intervention / Treatment
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* Other: aromatherapy
* Other: foot bath


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: foot bath only<br>10 minute foot bath with addition of jojoba only | Other: foot bath<br> <br> |
| Experimental: foot bath and aromatherapy<br>10 minute foot bath with addition of jojoba with added Mentha piperita | Other: aromatherapy<br> <br> * Other names: Mentha piperita;Other: foot bath<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of Adverse Events | assessment of presence or absence of Adverse Events or Serious Adverse Events | 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aromatherapy, peppermint