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

NCT03513536 | Completed

• 1 other identifier: 18-2300
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Morning Sickness; Pregnancy Early

Keywords

Aromatherapy; Essential Oils

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Health Related Quality of Life for Nausea and Vomiting of Pregnancy 30-part scale

  baseline and day 6

Study Arms (4)

Intervention 1

EXPERIMENTAL

The women in this arm will receive the Citrus-Based Aromatherapy product to apply regularly for 6 days.

Other: Citrus-Based Aromatherapy

Intervention 2

EXPERIMENTAL

The women in this arm will receive the Mint-Based Aromatherapy product to apply regularly for 6 days.

Other: Mint-Based Aromatherapy

Intervention 3

EXPERIMENTAL

The women in this arm will receive the Spice-Scented Aromatherapy product to apply regularly for 6 days.

Other: Spice-Scented Aromatherapy

Control

PLACEBO COMPARATOR

The women in this arm will receive a vegetable oil roll-on product to apply regularly for 6 days.

Other: Control

Interventions

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.

Intervention 1

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.

Intervention 2

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.

Intervention 3

Control OTHER

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

Control

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Nutraceuticals Research Institute: lead

Study Sites (1)

Franklin Institute of Wellness

Franklin, Tennessee, 37067, United States

Location

MeSH Terms

Conditions

Morning Sickness

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vomiting; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jessie Hawkins, PhD

  Nutraceuticals Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2018
• First Posted: May 1, 2018
• Study Start: April 15, 2018
• Primary Completion: August 1, 2019
• Study Completion: March 29, 2020
• Last Updated: April 29, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)