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

NCT ID: NCT03513536

Last Updated: 2020-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-15

Study Completion Date

2020-03-29

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Morning Sickness Pregnancy Early

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Intervention 1

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

Group Type EXPERIMENTAL

Citrus-Based Aromatherapy

Intervention Type 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

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

Group Type EXPERIMENTAL

Mint-Based Aromatherapy

Intervention Type 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

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

Group Type EXPERIMENTAL

Spice-Scented Aromatherapy

Intervention Type 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

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

Group Type PLACEBO_COMPARATOR

Control

Intervention Type OTHER

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

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Control

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* hyperemesis gravidarum
* tobacco use in the home
* high risk pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Nutraceuticals Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jessie Hawkins, PhD

Role: PRINCIPAL_INVESTIGATOR

Nutraceuticals Research Institute

Locations

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Franklin Institute of Wellness

Franklin, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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18-2300

Identifier Type: -

Identifier Source: org_study_id

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