A Preliminary Investigation of the Efficacy of Aromatherapy in Reducing Discomfort in Youth With Chronic Headache
CompletedNot applicableNCT02440997
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- A Preliminary Investigation of the Efficacy of Aromatherapy in Reducing Discomfort in Youth With Chronic Headache
- Conditions
- Chronic Headache
- Migraine Headache
- Headache
- Interventions
- Other: aromatherapy
- Other: foot bath
- Sponsor
- Children's Mercy Hospital Kansas City
- Start date
- 2015-03-25
- Primary completion
- 2017-01-04
- Sex
- All
- Age range
- from 7 Years to 17 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02440997