The Effect of Aroma on Fatigue Scores Among Women With Hypothyroidism

NCT ID: NCT03465176

Last Updated: 2018-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-11

Study Completion Date

2018-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Fatigue Hypothyroidism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Intervention

The women in this arm will receive an essential oil blend to inhale each afternoon for two weeks.

Group Type EXPERIMENTAL

Aromatherapy Blend

Intervention Type 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.

Control

The women in this arm will receive an odorless vegetable based oil to inhale each afternoon for two weeks as a control/placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Placebo

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* female
* diagnosed with hypothyroidism
* otherwise healthy

Exclusion Criteria

• history of thyroid cancer
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Nutraceuticals Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Franklin Institute of Wellness

Franklin, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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1600

Identifier Type: -

Identifier Source: org_study_id

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