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

Primary Purpose

Chronic Headache, Migraine Headache, Headache

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
aromatherapy
foot bath
Sponsored by
Children's Mercy Hospital Kansas City
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Headache focused on measuring aromatherapy, peppermint

Eligibility Criteria

7 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Mercy Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

foot bath only

foot bath and aromatherapy

Arm Description

10 minute foot bath with addition of jojoba only

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

Outcomes

Primary Outcome Measures

improvement in subjective and objective indicators of discomfort
pain and anxiety measured subjectively via VAS
improvement in subjective and objective indicators of discomfort
heart rate variability measured -10, 10 and 20 minutes

Secondary Outcome Measures

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

Full Information

First Posted
April 22, 2015
Last Updated
April 7, 2017
Sponsor
Children's Mercy Hospital Kansas City
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1. Study Identification

Unique Protocol Identification Number
NCT02440997
Brief Title
A Preliminary Investigation of the Efficacy of Aromatherapy in Reducing Discomfort in Youth With Chronic Headache
Official Title
A Preliminary Investigation of the Efficacy of Aromatherapy in Reducing Discomfort in Youth With Chronic Headache
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
March 25, 2015 (Actual)
Primary Completion Date
January 4, 2017 (Actual)
Study Completion Date
January 4, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Mercy Hospital Kansas City

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Headache, Migraine Headache, Headache
Keywords
aromatherapy, peppermint

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
foot bath only
Arm Type
Placebo Comparator
Arm Description
10 minute foot bath with addition of jojoba only
Arm Title
foot bath and aromatherapy
Arm Type
Experimental
Arm Description
10 minute foot bath with addition of jojoba with added Mentha piperita
Intervention Type
Other
Intervention Name(s)
aromatherapy
Other Intervention Name(s)
Mentha piperita
Intervention Type
Other
Intervention Name(s)
foot bath
Primary Outcome Measure Information:
Title
improvement in subjective and objective indicators of discomfort
Description
pain and anxiety measured subjectively via VAS
Time Frame
30 minutes
Title
improvement in subjective and objective indicators of discomfort
Description
heart rate variability measured -10, 10 and 20 minutes
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
number of Adverse Events
Description
assessment of presence or absence of Adverse Events or Serious Adverse Events
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rae A Kingsley, MSN, APRN
Organizational Affiliation
Children's Mercy Hospital Kansas City
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States

12. IPD Sharing Statement

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Links:
URL
http://www.heartmath.com
Description
developing and delivering research-based, practical, and reliable tools and technologies
URL
http://ihs-classification.org/en/
Description
headache classification
URL
http://www.cancer.gov/cancertopics/pdq/cam/aromatherapy/healthprofessional/
Description
Aromatherapy and Essential Oils (PDQ). National Cancer Institute at the National Institutes of Health
URL
http://www.naturalstandard.com
Description
Peppermint oil (Mentha x piperita L.). Natural Standard Database Web site.
URL
http://www.randomizer.org/
Description
Research Randomizer ©1997-2008 by Geoffery C. Urbaniak and Scott Plous Social Psychology Network

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

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