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Completed

NCT Number: NCT03513536

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.

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Key information

Conditions

Morning Sickness Female Urogenital Diseases and Pregnancy Complications Pathological Conditions, Signs and Symptoms Pregnancy Complications Pregnancy Early Signs and Symptoms Signs and Symptoms, Digestive Urogenital Diseases Vomiting

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Franklin Institute of Wellness

Franklin, Tennessee, 37067, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Citrus-Based Aromatherapy

Other

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

Other

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

Other

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

Other

This control is a blend of plant derived oils which have been expressed from crude plant matter.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Nutraceuticals Research Institute

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
May 1, 2018
Registry last updated
Apr 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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