Morning Sickness, Pregnancy Early
Conditions
Keywords
Aromatherapy, Essential Oils
Brief summary
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
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.
Interventions
OTHERCitrus-Based Aromatherapy
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.
OTHERMint-Based Aromatherapy
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.
OTHERSpice-Scented Aromatherapy
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.
OTHERControl
This control is a blend of plant derived oils which have been expressed from crude plant matter.
Sponsors
Nutraceuticals Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* age: 18-45 years * confirmed pregnancy * healthy pregnancy
Exclusion criteria
* hyperemesis gravidarum * tobacco use in the home * high risk pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Nausea and Vomiting 6-part Quantification of Emesis scale | daily for 6 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health Related Quality of Life for Nausea and Vomiting of Pregnancy 30-part scale | baseline and day 6 | 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. |
Countries
United States
Outcome results
None listed