We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02440997
Recruitment Status : Completed
First Posted : May 12, 2015
Last Update Posted : April 10, 2017
Sponsor:
Information provided by (Responsible Party):
Children's Mercy Hospital Kansas City

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Chronic Headache Migraine Headache Headache Other: aromatherapy Other: foot bath Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Preliminary Investigation of the Efficacy of Aromatherapy in Reducing Discomfort in Youth With Chronic Headache
Actual Study Start Date : March 25, 2015
Actual Primary Completion Date : January 4, 2017
Actual Study Completion Date : January 4, 2017

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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: aromatherapy
Other Name: Mentha piperita

Other: foot bath


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. improvement in subjective and objective indicators of discomfort [ Time Frame: 30 minutes ]
    pain and anxiety measured subjectively via VAS

  2. improvement in subjective and objective indicators of discomfort [ Time Frame: 30 minutes ]
    heart rate variability measured -10, 10 and 20 minutes


Secondary Outcome Measures :
  1. number of Adverse Events [ Time Frame: 30 minutes ]
    assessment of presence or absence of Adverse Events or Serious Adverse Events


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02440997


Locations
Layout table for location information
United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Investigators
Layout table for investigator information
Principal Investigator: Rae A Kingsley, MSN, APRN Children's Mercy Hospital Kansas City
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications:
Battaiglia, S. (2003). The complete guide to aromatherapy (2nd edition). Brisbane, Australia: The International Centre of Holistic Aromatherapy
Martin, I. (2007). Aromatherapy for Massage Practitioners. Lippincott Williams Wilkins; Baltimore, MD.
Mosby Skills Adapted from Perry, A.G., Potter, P.A., Ostendorf, W.R. (2014). Clinical nursing skills & techniques (8th ed.). St. Louis: Mosby
Tisserand, R. & Balacs, T. (1995). Essential oil safety. Edinburgh: Churchill Livingstone
Tisserand, R. & Young, R. (2014). Essential Oil Safety. A Guide for Health Care Professionals (2nd edition). Elsevier

Layout table for additonal information
Responsible Party: Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier: NCT02440997    
Other Study ID Numbers: IRB # 15010015
First Posted: May 12, 2015    Key Record Dates
Last Update Posted: April 10, 2017
Last Verified: April 2017
Keywords provided by Children's Mercy Hospital Kansas City:
aromatherapy, peppermint
Additional relevant MeSH terms:
Layout table for MeSH terms
Migraine Disorders
Headache Disorders
Headache
Pain
Neurologic Manifestations
 Headache Disorders, Primary
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases