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This study evaluates the effects of essential oils on nausea, vomiting, and quality of life scores among pregnant women. Participants will receive either an essential oil roll-on product or a placebo product to apply to their temples and jaw line daily for 6 days.
The inhalation of certain essential oils has been found to reduce feelings of nausea and to improve quality of life during pregnancy.
The essential oils used in this study are applied topically to the temples and jaw line every 4-6 waking hours over a 6-day period. Each application will produce an exposure that lasts up to 30-45 minutes before fading. At the end of each day, nausea and vomiting levels will be assessed using a validated measurement instrument.
Quality of life is measured using a 30-question tool that measures both pregnancy-related quality of life and pregnancy-induced nausea and vomiting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention 1 | Experimental | The women in this arm will receive the Citrus-Based Aromatherapy product to apply regularly for 6 days. |
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| Intervention 2 | Experimental | The women in this arm will receive the Mint-Based Aromatherapy product to apply regularly for 6 days. |
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| Intervention 3 | Experimental | The women in this arm will receive the Spice-Scented Aromatherapy product to apply regularly for 6 days. |
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| Control | Placebo Comparator | The women in this arm will receive a vegetable oil roll-on product to apply regularly for 6 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Citrus-Based Aromatherapy | Other | This 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Nausea and Vomiting 6-part Quantification of Emesis scale | Nausea and vomiting are measured once per day using the 6-item Quantification of Emesis 24-hour scale (PUQE) scale. This scale includes 3 questions which are ranked on a scale of 1-5, with higher scores indicating higher levels of pregnancy-induced nausea and vomiting. The other 3 questions are open-ended questions which ask participants about perceived well-being. | daily for 6 days |
| Measure | Description | Time Frame |
|---|---|---|
| Health Related Quality of Life for Nausea and Vomiting of Pregnancy 30-part scale | Quality of life is measured twice, at the start of the study and at the end of the study, using the Health Related Quality of Life for Nausea and Vomiting of Pregnancy (NVPQOL) instrument. This instrument includes 30 questions which are ranked on a Likert scale with 1 indicating "none of the time" and 7 indicating "all of the time." Higher scores indicate higher levels of nausea and vomiting, with reduced quality of life. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jessie Hawkins, PhD | Nutraceuticals Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Franklin Institute of Wellness | Franklin | Tennessee | 37067 | United States |
no plan to share
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| ID | Term |
|---|---|
| D048968 | Morning Sickness |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D014839 | Vomiting |
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| Mint-Based Aromatherapy | Other | This 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. |
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| Spice-Scented Aromatherapy | Other | This 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. |
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| Control | Other | This control is a blend of plant derived oils which have been expressed from crude plant matter. |
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| baseline and day 6 |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |