A Preliminary Investigation of the Efficacy of Aromatherapy in Reducing Discomfort in Youth With Chronic Headache
NCT ID: NCT02440997
Last Updated: 2017-04-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
46 participants
INTERVENTIONAL
2015-03-25
2017-01-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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foot bath only
10 minute foot bath with addition of jojoba only
foot bath
foot bath and aromatherapy
10 minute foot bath with addition of jojoba with added Mentha piperita
aromatherapy
foot bath
Interventions
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aromatherapy
foot bath
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
7 Years
17 Years
ALL
No
Sponsors
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Children's Mercy Hospital Kansas City
OTHER
Responsible Party
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Principal Investigators
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Rae A Kingsley, MSN, APRN
Role: PRINCIPAL_INVESTIGATOR
Children's Mercy Hospital Kansas City
Locations
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Children's Mercy Hospital
Kansas City, Missouri, United States
Countries
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References
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Battaiglia, S. (2003). The complete guide to aromatherapy (2nd edition). Brisbane, Australia: The International Centre of Holistic Aromatherapy
Blume HK. Pediatric headache: a review. Pediatr Rev. 2012 Dec;33(12):562-76. doi: 10.1542/pir.33-12-562. No abstract available.
Buckle J. Use of aromatherapy as a complementary treatment for chronic pain. Altern Ther Health Med. 1999 Sep;5(5):42-51.
Fitzgerald M, Culbert T, Finkelstein M, Green M, Liu M. The effect of gender and ethnicity on children's attitudes and preferences for essential oils: a follow up study. Explore (NY). 2010 May-Jun;6(3):172. doi: 10.1016/j.explore.2010.02.002. No abstract available.
Gardiner P, Wornham W. Recent review of complementary and alternative medicine used by adolescents. Curr Opin Pediatr. 2000 Aug;12(4):298-302. doi: 10.1097/00008480-200008000-00002.
Gaul C, Eismann R, Schmidt T, May A, Leinisch E, Wieser T, Evers S, Henkel K, Franz G, Zierz S. Use of complementary and alternative medicine in patients suffering from primary headache disorders. Cephalalgia. 2009 Oct;29(10):1069-78. doi: 10.1111/j.1468-2982.2009.01841.x. Epub 2009 Apr 2.
Gobel H, Schmidt G, Soyka D. Effect of peppermint and eucalyptus oil preparations on neurophysiological and experimental algesimetric headache parameters. Cephalalgia. 1994 Jun;14(3):228-34; discussion 182. doi: 10.1046/j.1468-2982.1994.014003228.x.
Halcon LL. Aromatherapy: therapeutic applications of plant essential oils. Minn Med. 2002 Nov;85(11):42-6.
Kabbouche MA, Linder SL. Acute treatment of pediatric headache in the emergency department and inpatient settings. Pediatr Ann. 2005 Jun;34(6):466-71. doi: 10.3928/0090-4481-20050601-12.
Keifer D, Ulbricht C, Abrams TR, Basch E, Giese N, Giles M, DeFranco Kirkwood C, Miranda M, Woods J. Peppermint (Mentha piperita): an evidence-based systematic review by the Natural Standard Research Collaboration. J Herb Pharmacother. 2007;7(2):91-143. doi: 10.1300/j157v07n02_07.
Kligler B, Chaudhary S. Peppermint oil. Am Fam Physician. 2007 Apr 1;75(7):1027-30.
Lee MS, Choi J, Posadzki P, Ernst E. Aromatherapy for health care: an overview of systematic reviews. Maturitas. 2012 Mar;71(3):257-60. doi: 10.1016/j.maturitas.2011.12.018. Epub 2012 Jan 27.
Lewis D, Ashwal S, Hershey A, Hirtz D, Yonker M, Silberstein S; American Academy of Neurology Quality Standards Subcommittee; Practice Committee of the Child Neurology Society. Practice parameter: pharmacological treatment of migraine headache in children and adolescents [RETIRED]: report of the American Academy of Neurology Quality Standards Subcommittee and the Practice Committee of the Child Neurology Society. Neurology. 2004 Dec 28;63(12):2215-24. doi: 10.1212/01.wnl.0000147332.41993.90.
Loman DG. The use of complementary and alternative health care practices among children. J Pediatr Health Care. 2003 Mar-Apr;17(2):58-63. doi: 10.1067/mph.2003.29.
Martin, I. (2007). Aromatherapy for Massage Practitioners. Lippincott Williams Wilkins; Baltimore, MD.
Mauskop A. Alternative therapies in headache. Is there a role? Med Clin North Am. 2001 Jul;85(4):1077-84. doi: 10.1016/s0025-7125(05)70360-6.
Mosby Skills Adapted from Perry, A.G., Potter, P.A., Ostendorf, W.R. (2014). Clinical nursing skills & techniques (8th ed.). St. Louis: Mosby
Nishimura M, Tatsuya Saito TS, Kato T, Onodera S. Effects of Water Temperature during Foot Bath in Young Females. Yonago Acta Med. 2013 Sep;56(3):79-80. Epub 2013 Sep 11.
Peterson CC, Palermo TM. Parental reinforcement of recurrent pain: the moderating impact of child depression and anxiety on functional disability. J Pediatr Psychol. 2004 Jul-Aug;29(5):331-41. doi: 10.1093/jpepsy/jsh037.
Posadzki P, Alotaibi A, Ernst E. Adverse effects of aromatherapy: a systematic review of case reports and case series. Int J Risk Saf Med. 2012 Jan 1;24(3):147-61. doi: 10.3233/JRS-2012-0568.
Roth-Isigkeit A, Thyen U, Stoven H, Schwarzenberger J, Schmucker P. Pain among children and adolescents: restrictions in daily living and triggering factors. Pediatrics. 2005 Feb;115(2):e152-62. doi: 10.1542/peds.2004-0682.
Saeki Y. The effect of foot-bath with or without the essential oil of lavender on the autonomic nervous system: a randomized trial. Complement Ther Med. 2000 Mar;8(1):2-7.
Saeki Y, Nagai N, Hishinuma M. Effects of footbathing on autonomic nerve and immune function. Complement Ther Clin Pract. 2007 Aug;13(3):158-65. doi: 10.1016/j.ctcp.2006.12.006. Epub 2007 Feb 20.
Schetzek S, Heinen F, Kruse S, Borggraefe I, Bonfert M, Gaul C, Gottschling S, Ebinger F. Headache in children: update on complementary treatments. Neuropediatrics. 2013 Feb;44(1):25-33. doi: 10.1055/s-0032-1333435. Epub 2013 Jan 11.
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Tisserand, R. & Young, R. (2014). Essential Oil Safety. A Guide for Health Care Professionals (2nd edition). Elsevier
von Baeyer CL. Interpreting the high prevalence of pediatric chronic pain revealed in community surveys. Pain. 2011 Dec;152(12):2683-2684. doi: 10.1016/j.pain.2011.08.023. Epub 2011 Sep 14. No abstract available.
Kingsley RA. Randomized Trial Examining Efficacy of Mentha piperita in Reducing Chronic Headache Discomfort in Youth. Pain Manag Nurs. 2023 Dec;24(6):e139-e147. doi: 10.1016/j.pmn.2023.08.004. Epub 2023 Sep 18.
Related Links
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developing and delivering research-based, practical, and reliable tools and technologies
headache classification
Aromatherapy and Essential Oils (PDQ). National Cancer Institute at the National Institutes of Health
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
Other Identifiers
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IRB # 15010015
Identifier Type: -
Identifier Source: org_study_id
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