A Preliminary Investigation of the Efficacy of Aromatherapy in Reducing

Status Completed

Clinical 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. 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02440997
Study type	Interventional
Source	Children's Mercy Hospital Kansas City
Contact
Status	Completed
Phase	N/A
Start date	March 25, 2015
Completion date	January 4, 2017

View Details

See also
Status	Clinical Trial	Phase
Withdrawn	`NCT03472872` - A Comparative Efficacy Trial of IV Acetaminophen Versus IV Ketorolac for Emergency Department Treatment of Generalized Headache	Phase 4
Withdrawn	`NCT05410366` - Safe Harbors in Emergency Medicine, Specific Aim 3
Withdrawn	`NCT02866084` - Neuromodulation Treatment of Vestibular Migraines	N/A
Active, not recruiting	`NCT03537573` - Provider-Targeted Behavioral Interventions to Prevent Unsafe Opioid Prescribing for Acute Pain in Primary Care	N/A
Recruiting	`NCT05891808` - miR-155 Expression in Episodic and Chronic Migraine
Not yet recruiting	`NCT04352218` - Safety Profile of PETALO CVS in the Treatment of Non-thrombotic Internal Jugular Vein Stenosis and Chronic Headache	Phase 2
Completed	`NCT02734992` - Acceptance and Commitment Therapy vs Medical Treatment as Usual Wait-list Control for Primary Headache Sufferers	N/A
Completed	`NCT01153789` - Study of Oculomotor Dysfunction Leading to Children Vertigo	N/A
Completed	`NCT01327118` - Prostaglandin F2alpha in a Human Headache Model	N/A
Not yet recruiting	`NCT00969995` - Identification of Inflammatory Markers in Migraine Patients	N/A
Not yet recruiting	`NCT00752921` - Randomized Placebo Controlled Trial With Etoricoxib That is Taken to Prevent the Yom Kippur Headache	Phase 4
Terminated	`NCT00291395` - PGI2 Induced Headache and Cerebral Haemodynamics in Healthy Volunteers	Phase 1
Completed	`NCT00212810` - Evaluation of the Effectiveness of Topiramate in Preventing the Transformation From Episodic Migraine to Chronic Daily Headache.	Phase 4
Completed	`NCT00263094` - An End to the Yom Kippur (and Ramadan) Headache	N/A
Completed	`NCT00135122` - Prednisolone in the Treatment of Withdrawal Headache in Probable Medication Overuse Headache	Phase 3
Completed	`NCT02475005` - An Intervention to Improve Adolescent Headache Self-management	N/A
Completed	`NCT03163901` - The Effect of OMT on Functional Outcomes and Anti-inflammatory Biomarkers in Mild to Moderate Traumatic Brain Injury	N/A
Completed	`NCT01664585` - Exercise Training With Physically Active Lifestyle to Reduce Headache and Quality of Life	N/A
Completed	`NCT04632420` - Evaluation of Headache and Childbirth in a Chronic Pain Population
Recruiting	`NCT05033613` - Home Blood Pressure Monitoring Before and After COVID-19 Vaccination in Patients at High Risk of Cardiovascular Disease

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms