The Effect of Aroma on Fatigue Scores Among Women With Hypothyroidism

Fatigue Clinical Trial

Official title:

The Effect of Aroma on Fatigue Scores Among Women With Hypothyroidism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03465176
• Other study ID #: 1600
• Status: Completed
• Phase: N/A
• Start date: July 11, 2017
• Est. completion date: May 31, 2018

Study information

• Verified date: July 2018
• Source: Franklin Institute of Wellness
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: May 31, 2018
• Est. primary completion date: March 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• female

• diagnosed with hypothyroidism

• otherwise healthy

Exclusion Criteria:

• history of thyroid cancer

Related Conditions & MeSH terms

• Fatigue
• Hypothyroidism

Intervention

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
The placebo substance is an odorless vegetable oil derived from avocados.

Locations

Country	Name	City	State
United States	Franklin Institute of Wellness	Franklin	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Franklin Institute of Wellness

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	83-item Multidimensional Symptoms of Fatigue Inventory	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.	2 weeks