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

Pregnancy Early Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03513536
• Other study ID #: 18-2300
• Status: Completed
• Phase: N/A
• Start date: April 15, 2018
• Est. completion date: March 29, 2020

Study information

• Verified date: April 2020
• Source: Franklin Institute of Wellness
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: March 29, 2020
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• age: 18-45 years

• confirmed pregnancy

• healthy pregnancy

Exclusion Criteria:

• hyperemesis gravidarum

• tobacco use in the home

• high risk pregnancy

Related Conditions & MeSH terms

• Morning Sickness
• Pregnancy Early
• Vomiting

Intervention

Other:
• Citrus-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.
• Mint-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.
• Spice-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.
• Control
This control is a blend of plant derived oils which have been expressed from crude plant matter.

Locations

Country	Name	City	State
United States	Franklin Institute of Wellness	Franklin	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Franklin Institute of Wellness

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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