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

Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02440997
• Other study ID #: IRB # 15010015
• Status: Completed
• Phase: N/A
• First received: April 22, 2015
• Last updated: April 7, 2017
• Start date: March 25, 2015
• Est. completion date: January 4, 2017

Study information

• Verified date: April 2017
• Source: Children's Mercy Hospital Kansas City
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: January 4, 2017
• Est. primary completion date: January 4, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Headache
• Headache
• Headache Disorders
• Migraine Disorders
• Migraine Headache

Intervention

Other:
• aromatherapy

• foot bath

Locations

Country	Name	City	State
United States	Children's Mercy Hospital	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City

Country where clinical trial is conducted

United States, 

References & Publications (31)

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* Note: There are 31 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	improvement in subjective and objective indicators of discomfort	pain and anxiety measured subjectively via VAS	30 minutes
Primary	improvement in subjective and objective indicators of discomfort	heart rate variability measured -10, 10 and 20 minutes	30 minutes
Secondary	number of Adverse Events	assessment of presence or absence of Adverse Events or Serious Adverse Events	30 minutes

External Links

•   Aromatherapy and Essential Oils (PDQ). National Cancer Institute at the National Institutes of Health
•   developing and delivering research-based, practical, and reliable tools and technologies
•   headache classification
•   Peppermint oil (Mentha x piperita L.). Natural Standard Database Web site.
•   Research Randomizer ©1997-2008 by Geoffery C. Urbaniak and Scott Plous Social Psychology Network