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The Effect of Aroma on Fatigue Scores Among Women With Hypothyroidism

Primary Purpose

Fatigue, Hypothyroidism

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aromatherapy Blend
Placebo
Sponsored by
Franklin Health Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fatigue focused on measuring aromatherapy, fatigue, hypothyroidism, essential oils

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • female
  • diagnosed with hypothyroidism
  • otherwise healthy

Exclusion Criteria:

• history of thyroid cancer

Sites / Locations

  • Franklin Institute of Wellness

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 8, 2018
Last Updated
July 31, 2018
Sponsor
Franklin Health Research
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1. Study Identification

Unique Protocol Identification Number
NCT03465176
Brief Title
The Effect of Aroma on Fatigue Scores Among Women With Hypothyroidism
Official Title
The Effect of Aroma on Fatigue Scores Among Women With Hypothyroidism
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
July 11, 2017 (Actual)
Primary Completion Date
March 30, 2018 (Actual)
Study Completion Date
May 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Franklin Health Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue, Hypothyroidism
Keywords
aromatherapy, fatigue, hypothyroidism, essential oils

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
The women in this arm will receive an essential oil blend to inhale each afternoon for two weeks.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
The women in this arm will receive an odorless vegetable based oil to inhale each afternoon for two weeks as a control/placebo.
Intervention Type
Other
Intervention Name(s)
Aromatherapy Blend
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
The placebo substance is an odorless vegetable oil derived from avocados.
Primary Outcome Measure Information:
Title
83-item Multidimensional Symptoms of Fatigue Inventory
Description
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.
Time Frame
2 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: female diagnosed with hypothyroidism otherwise healthy Exclusion Criteria: • history of thyroid cancer
Facility Information:
Facility Name
Franklin Institute of Wellness
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States

12. IPD Sharing Statement

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The Effect of Aroma on Fatigue Scores Among Women With Hypothyroidism

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