The Effect of Scent on Pregnancy Induced Nausea, Vomiting, and Quality of Life

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effect of Scent on Pregnancy Induced Nausea, Vomiting, and Quality of Life

Conditions
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Morning Sickness, Pregnancy Early

Intervention / Treatment
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* Other: Citrus-Based Aromatherapy
* Other: Mint-Based Aromatherapy
* Other: Spice-Scented Aromatherapy
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age: 18-45 years confirmed pregnancy healthy pregnancy Exclusion Criteria: hyperemesis gravidarum tobacco use in the home high risk pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention 1<br>The women in this arm will receive the Citrus-Based Aromatherapy product to apply regularly for 6 days. | Other: Citrus-Based Aromatherapy<br>* 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.<br>|
| Experimental: Intervention 2<br>The women in this arm will receive the Mint-Based Aromatherapy product to apply regularly for 6 days. | Other: Mint-Based Aromatherapy<br>* 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.<br>|
| Experimental: Intervention 3<br>The women in this arm will receive the Spice-Scented Aromatherapy product to apply regularly for 6 days. | Other: Spice-Scented Aromatherapy<br>* 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.<br>|
| Placebo Comparator: Control<br>The women in this arm will receive a vegetable oil roll-on product to apply regularly for 6 days. | Other: Control<br>* This control is a blend of plant derived oils which have been expressed from crude plant matter.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | baseline and day 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aromatherapy, Essential Oils