Working… Menu
Trial record 49 of 238 for:    essential oil

The Effect of Aroma on Fatigue Scores Among Women With Hypothyroidism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03465176
Recruitment Status : Completed
First Posted : March 14, 2018
Last Update Posted : August 1, 2018
Information provided by (Responsible Party):
Franklin Institute of Wellness

Brief Summary:
This study evaluates the effects of an inhaled blend of essential oils on fatigue scores among women who have hypothyroidism. Half of the participants will receive an essential oil blend to inhale daily for two weeks while the other half will serve as controls and inhale a carrier oil.

Condition or disease Intervention/treatment Phase
Fatigue Hypothyroidism Other: Aromatherapy Blend Other: Placebo Not Applicable

Detailed Description:

The inhalation of certain essential oils has been found to increase stamina and reduce fatigue among athletes but have not been evaluated for the purpose of reducing fatigue among women who experience fatigue as a result of a hypothyroid condition.

The essential oils used in this study are inhaled mid-afternoon, the time in which women with hypothyroidism typically experience the lowest levels of energy during the day, otherwise known as the "afternoon slump." The essential oil is administered during this time to evaluate both the immediate effects on fatigue as well as the overall effects, with measurements at the end of both the first and second week of the study.

Fatigue is measured on a multi-dimensional scale, a validated instrument that measures not only physical fatigue but also emotional and mental fatigue.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Effect of Aroma on Fatigue Scores Among Women With Hypothyroidism
Actual Study Start Date : July 11, 2017
Actual Primary Completion Date : March 30, 2018
Actual Study Completion Date : May 31, 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Intervention
The women in this arm will receive an essential oil blend to inhale each afternoon for two weeks.
Other: Aromatherapy Blend
The essential oil intervention is a blend of plant derived oils which have been distilled from crude plant matter and analyzed in a laboratory to identify chemical composition.

Placebo Comparator: Control
The women in this arm will receive an odorless vegetable based oil to inhale each afternoon for two weeks as a control/placebo.
Other: Placebo
The placebo substance is an odorless vegetable oil derived from avocados.

Primary Outcome Measures :
  1. 83-item Multidimensional Symptoms of Fatigue Inventory [ Time Frame: 2 weeks ]
    This measurement collects self reported fatigue scores at baseline and at the end of each week of the intervention. Each item is scored from 0-4, with higher scores indicating greater levels of fatigue.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • female
  • diagnosed with hypothyroidism
  • otherwise healthy

Exclusion Criteria:

• history of thyroid cancer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03465176

Layout table for location information
United States, Tennessee
Franklin Institute of Wellness
Franklin, Tennessee, United States, 37067
Sponsors and Collaborators
Franklin Institute of Wellness

Layout table for additonal information
Responsible Party: Franklin Institute of Wellness Identifier: NCT03465176     History of Changes
Other Study ID Numbers: 1600
First Posted: March 14, 2018    Key Record Dates
Last Update Posted: August 1, 2018
Last Verified: July 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Franklin Institute of Wellness:
essential oils
Additional relevant MeSH terms:
Layout table for MeSH terms
Signs and Symptoms
Thyroid Diseases
Endocrine System Diseases