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

Not Applicable

Completed

• Conditions: Chronic Headache; Migraine Headache; Headache
• Interventions: Other: aromatherapy; Other: foot bath

• Registration Number: NCT02440997
• Lead Sponsor: Children's Mercy Hospital Kansas City

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2015-03-25
• Study First Submitted: 2015-04-22
• Study First Submitted QC: 2015-05-07
• Study First Posted: 2015-05-12
• Primary Completion: 2017-01-04
• Study Completion: 2017-01-04
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-07
• Last Update Posted: 2017-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
foot bath and aromatherapy	aromatherapy	10 minute foot bath with addition of jojoba with added Mentha piperita
foot bath only	foot bath	10 minute foot bath with addition of jojoba only
foot bath and aromatherapy	foot bath	10 minute foot bath with addition of jojoba with added Mentha piperita

Primary Outcome Measures

Name	Time	Method
improvement in subjective and objective indicators of discomfort	30 minutes	heart rate variability measured -10, 10 and 20 minutes

Secondary Outcome Measures

Name	Time	Method
number of Adverse Events	30 minutes	assessment of presence or absence of Adverse Events or Serious Adverse Events

Trial Locations

Locations (1)

Children's Mercy Hospital; 🇺🇸 Kansas City, Missouri, United States