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

NCT02440997 | Completed

• 1 other identifier: IRB # 15010015
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Headache; Migraine Headache; Headache

Keywords

aromatherapy, peppermint

Outcome Measures

Primary Outcomes (2)

• improvement in subjective and objective indicators of discomfort

  pain and anxiety measured subjectively via VAS

  30 minutes

• improvement in subjective and objective indicators of discomfort

  heart rate variability measured -10, 10 and 20 minutes

  30 minutes

Secondary Outcomes (1)

• number of Adverse Events

  30 minutes

Study Arms (2)

foot bath only

PLACEBO COMPARATOR

10 minute foot bath with addition of jojoba only

Other: foot bath

foot bath and aromatherapy

EXPERIMENTAL

10 minute foot bath with addition of jojoba with added Mentha piperita

Other: aromatherapy; Other: foot bath

Interventions

aromatherapy OTHER

Also known as: Mentha piperita

foot bath and aromatherapy

foot bath OTHER

foot bath and aromatherapy; foot bath only

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead

Study Sites (1)

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Related Publications (32)

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Related Links

• 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

MeSH Terms

Conditions

Headache Disorders; Migraine Disorders; Headache

Interventions

Aromatherapy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Phytotherapy; Sensory Art Therapies; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Rae A Kingsley, MSN, APRN

  Children's Mercy Hospital Kansas City

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2015
• First Posted: May 12, 2015
• Study Start: March 25, 2015
• Primary Completion: January 4, 2017
• Study Completion: January 4, 2017
• Last Updated: April 10, 2017

Record last verified: 2017-04

Locations

US (1)