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

• ClinicalTrials.gov Identifier: NCT03513536
• Recruitment Status: Completed
• First Posted: May 1, 2018
• Last Update Posted: April 29, 2020
• Sponsor: Franklin Health Research
• Information provided by (Responsible Party): Franklin Health Research

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Morning Sickness; Pregnancy Early	Other: Citrus-Based Aromatherapy; Other: Mint-Based Aromatherapy; Other: Spice-Scented Aromatherapy; Other: Control	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 74 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Treatment
• Official Title: The Effect of Scent on Pregnancy Induced Nausea, Vomiting, and Quality of Life
• Actual Study Start Date: April 15, 2018
• Actual Primary Completion Date: August 1, 2019
• Actual Study Completion Date: March 29, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Change from Nausea and Vomiting 6-part Quantification of Emesis scale [ Time Frame: 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 Outcome Measures :

1. Health Related Quality of Life for Nausea and Vomiting of Pregnancy 30-part scale [ Time Frame: 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.

Eligibility Criteria

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

United States, Tennessee

Franklin Institute of Wellness

Franklin, Tennessee, United States, 37067

Sponsors and Collaborators

Franklin Health Research

Investigators

• Principal Investigator: Jessie Hawkins, PhD; Franklin Health Research

More Information

• Responsible Party: Franklin Health Research
• ClinicalTrials.gov Identifier: NCT03513536
• Other Study ID Numbers: 18-2300
• First Posted: May 1, 2018
• Last Update Posted: April 29, 2020
• Last Verified: April 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: no plan to share

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Franklin Health Research:

Aromatherapy; Essential Oils

Additional relevant MeSH terms:

Morning Sickness; Vomiting; Signs and Symptoms, Digestive; Pregnancy Complications