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Completed

NCT Number: NCT03465176

The Effect of Aroma on Fatigue Scores Among Women With Hypothyroidism

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.

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Key information

Conditions

Fatigue Endocrine System Diseases Hypothyroidism Pathological Conditions, Signs and Symptoms Signs and Symptoms Thyroid Diseases

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Franklin Institute of Wellness

Franklin, Tennessee, 37067, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • female
  • diagnosed with hypothyroidism
  • otherwise healthy

Exclusion criteria

  • history of thyroid cancer

Treatment and study plan

Aromatherapy Blend

Other

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

Other

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

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Nutraceuticals Research Institute

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 14, 2018
Registry last updated
Aug 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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