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Trial record 55 of 73 for:    aromatherapy

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.
ClinicalTrials.gov Identifier: NCT03465176
Recruitment Status : Completed
First Posted : March 14, 2018
Last Update Posted : August 1, 2018
Sponsor:
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.


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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

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT03465176


Locations
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United States, Tennessee
Franklin Institute of Wellness
Franklin, Tennessee, United States, 37067
Sponsors and Collaborators
Franklin Institute of Wellness

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Responsible Party: Franklin Institute of Wellness
ClinicalTrials.gov 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

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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:
aromatherapy
fatigue
hypothyroidism
essential oils

Additional relevant MeSH terms:
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Fatigue
Hypothyroidism
Signs and Symptoms
Thyroid Diseases
Endocrine System Diseases