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

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.

Study Overview

• Status: Completed
• Conditions: Morning Sickness; Pregnancy Early
• Intervention / Treatment: Other: Citrus-Based Aromatherapy; Other: Mint-Based Aromatherapy; Other: Spice-Scented Aromatherapy; Other: Control

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.

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Franklin, Tennessee, United States, 37067
      • Franklin Institute of Wellness

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• age: 18-45 years
• confirmed pregnancy
• healthy pregnancy

Exclusion Criteria:

• hyperemesis gravidarum
• tobacco use in the home
• high risk pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Franklin Health Research

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2018
• Primary Completion (Actual): August 1, 2019
• Study Completion (Actual): March 29, 2020

Study Registration Dates

• First Submitted: April 5, 2018
• First Submitted That Met QC Criteria: April 30, 2018
• First Posted (Actual): May 1, 2018

Study Record Updates

• Last Update Posted (Actual): April 29, 2020
• Last Update Submitted That Met QC Criteria: April 27, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Aromatherapy; Essential Oils
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Pregnancy Complications; Vomiting; Morning Sickness
• Other Study ID Numbers: 18-2300

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: no plan to share

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No