The Effect of Aroma on Fatigue Scores Among Women With Hypothyroidism

Study Overview
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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.

Official Title
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The Effect of Aroma on Fatigue Scores Among Women With Hypothyroidism

Conditions
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Fatigue, Hypothyroidism

Intervention / Treatment
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* Other: Aromatherapy Blend
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: female diagnosed with hypothyroidism otherwise healthy Exclusion Criteria: • history of thyroid cancer

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>The women in this arm will receive an essential oil blend to inhale each afternoon for two weeks. | Other: Aromatherapy Blend<br>* 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.<br>|
| Placebo Comparator: Control<br>The women in this arm will receive an odorless vegetable based oil to inhale each afternoon for two weeks as a control/placebo. | Other: Placebo<br>* The placebo substance is an odorless vegetable oil derived from avocados.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aromatherapy, fatigue, hypothyroidism, essential oils