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

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ClinicalTrials.gov Identifier: NCT03513536
Recruitment Status : Recruiting
First Posted : May 1, 2018
Last Update Posted : May 1, 2018
Sponsor:
Information provided by (Responsible Party):
Franklin Institute of Wellness

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 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
Estimated Primary Completion Date : February 1, 2019
Estimated Study Completion Date : March 29, 2019

Resource links provided by the National Library of Medicine


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.




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.



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03513536


Contacts
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Contact: Jessie Hawkins, PhD 6152613116 info@franklininstituteofwellness.com

Locations
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United States, Tennessee
Franklin Institute of Wellness Recruiting
Franklin, Tennessee, United States, 37067
Contact: Jessie Hawkins, PhD    615-261-3116    info@franklininstituteofwellness.com   
Sponsors and Collaborators
Franklin Institute of Wellness
Investigators
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Principal Investigator: Jessie Hawkins, PhD Franklin Institute of Wellness

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Responsible Party: Franklin Institute of Wellness
ClinicalTrials.gov Identifier: NCT03513536     History of Changes
Other Study ID Numbers: 18-2300
First Posted: May 1, 2018    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: no plan to share

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Franklin Institute of Wellness:
Aromatherapy
Essential Oils
Additional relevant MeSH terms:
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Morning Sickness
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Pregnancy Complications