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

April 7, 2017 updated by: Children's Mercy Hospital Kansas City
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Children's Mercy Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: foot bath only
10 minute foot bath with addition of jojoba only
Other: foot bath
Experimental: foot bath and aromatherapy
10 minute foot bath with addition of jojoba with added Mentha piperita
Other: foot bath
Other: aromatherapy
Other Names:
  • Mentha piperita

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
improvement in subjective and objective indicators of discomfort
Time Frame: 30 minutes
pain and anxiety measured subjectively via VAS
30 minutes
improvement in subjective and objective indicators of discomfort
Time Frame: 30 minutes
heart rate variability measured -10, 10 and 20 minutes
30 minutes

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Mercy Hospital Kansas City

Investigators

  • Principal Investigator: Rae A Kingsley, MSN, APRN, Children's Mercy Hospital Kansas City

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 25, 2015

Primary Completion (Actual)

January 4, 2017

Study Completion (Actual)

January 4, 2017

Study Registration Dates

First Submitted

April 22, 2015

First Submitted That Met QC Criteria

May 7, 2015

First Posted (Estimate)

May 12, 2015

Study Record Updates

Last Update Posted (Actual)

April 10, 2017

Last Update Submitted That Met QC Criteria

April 7, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB # 15010015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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