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Clinical Trials/NCT03465176
NCT03465176CompletedNot Applicable

The Effect of Aroma on Fatigue Scores Among Women With Hypothyroidism

Franklin Health Research2 sites in 1 country42 target enrollmentStarted: July 11, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
42
Locations
2
Primary Endpoint
83-item Multidimensional Symptoms of Fatigue Inventory

Study Overview

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.

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 55 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • diagnosed with hypothyroidism
  • otherwise healthy

Exclusion Criteria

  • history of thyroid cancer

Arms & Interventions

Control

Placebo Comparator

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

Intervention: Placebo (Other)

Intervention

Experimental

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

Intervention: Aromatherapy Blend (Other)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Franklin Health Research
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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