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Chronic HeadacheNCT02440997

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

A study testing aromatherapy and foot bath in people with Chronic Headache and Migraine Headache, run by Children's Mercy Hospital Kansas City at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 7 to 17 years
Conditions the study is for
Chronic Headache, Migraine Headache, Headache
What is being tested?
aromatherapy and foot bath
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
46 participants
Where
1 siteUnited States
Study dates
25 Mar 2015to 4 Jan 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • • 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

Who cannot join

  • • 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)
Show all 11Show fewer
  • Past or concurrent history of olfactory impairment
  • Concomitant use of propanolol
  • Tobacco use
  • Hepatotoxicity
  • Pregnancy

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Children's Mercy Hospital

    Kansas City, Missouri, 64108

Other trials in United States

About this study

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.

Read the 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.

Being tested
aromatherapy, foot bath
Keywords
aromatherapy, peppermint
Medical subject headings
Headache Disorders, Migraine Disorders, Headache

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • aromatherapyOther

    Also called Mentha piperita

  • foot bathOther

Study groups in NCT02440997
Study groupRoleWhat they receive
foot bath onlyPlacebo comparator10 minute foot bath with addition of jojoba only
Receives: Other: foot bath
foot bath and aromatherapyExperimental10 minute foot bath with addition of jojoba with added Mentha piperita
Receives: Other: aromatherapy; Other: foot bath

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. improvement in subjective and objective indicators of discomfort

    pain and anxiety measured subjectively via VAS

    Measured: 30 minutes

  2. improvement in subjective and objective indicators of discomfort

    heart rate variability measured -10, 10 and 20 minutes

    Measured: 30 minutes

Secondary outcomes (1)

  1. number of Adverse Events

    assessment of presence or absence of Adverse Events or Serious Adverse Events

    Measured: 30 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2015 (estimated)
  2. Study start25 Mar 2015
  3. Primary completion4 Jan 2017
  4. Study completion4 Jan 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02440997
Sponsor's protocol ID
IRB # 15010015
Status last verified
Apr 2017
First submitted
22 Apr 2015
Last updated
10 Apr 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 23204398

  • Buckle J. Use of aromatherapy as a complementary treatment for chronic pain. Altern Ther Health Med. 1999 Sep;5(5):42-51.

    PubMed 10484830

  • 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.

    PubMed 20451151

  • 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.

    PubMed 10943807

  • 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.

    PubMed 19366356

  • 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.

    PubMed 7954745

  • Halcon LL. Aromatherapy: therapeutic applications of plant essential oils. Minn Med. 2002 Nov;85(11):42-6.

    PubMed 12498066

  • 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.

    PubMed 16018229

  • 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.

    PubMed 18285310

  • Kligler B, Chaudhary S. Peppermint oil. Am Fam Physician. 2007 Apr 1;75(7):1027-30.

    PubMed 17427617

  • 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.

    PubMed 22285469

  • 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.

    PubMed 15623677

  • 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.

    PubMed 12665727

  • Martin, I. (2007). Aromatherapy for Massage Practitioners. Lippincott Williams Wilkins; Baltimore, MD.

Questions about this trial

What is this clinical trial studying?

A study testing aromatherapy and foot bath in people with Chronic Headache and Migraine Headache, run by Children's Mercy Hospital Kansas City at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

improvement in subjective and objective indicators of discomfort (time frame: 30 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02440997, which also lists 32 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2017.

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