Back to resultsThe Effect of Scent on Pregnancy Induced Nausea, Vomiting, and Quality of Life
Primary Purpose
Morning Sickness, Pregnancy Early
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Citrus-Based Aromatherapy
Mint-Based Aromatherapy
Spice-Scented Aromatherapy
Control
Sponsored by
About this trial
This is an interventional treatment trial for Morning Sickness focused on measuring Aromatherapy, Essential Oils
Eligibility Criteria
Inclusion Criteria:
- age: 18-45 years
- confirmed pregnancy
- healthy pregnancy
Exclusion Criteria:
- hyperemesis gravidarum
- tobacco use in the home
- high risk pregnancy
Sites / Locations
- Franklin Institute of Wellness
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Intervention 1
Intervention 2
Intervention 3
Control
Arm Description
The women in this arm will receive the Citrus-Based Aromatherapy product to apply regularly for 6 days.
The women in this arm will receive the Mint-Based Aromatherapy product to apply regularly for 6 days.
The women in this arm will receive the Spice-Scented Aromatherapy product to apply regularly for 6 days.
The women in this arm will receive a vegetable oil roll-on product to apply regularly for 6 days.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Health Related Quality of Life for Nausea and Vomiting of Pregnancy 30-part scale
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03513536
Brief Title
The Effect of Scent on Pregnancy Induced Nausea, Vomiting, and Quality of Life
Official Title
The Effect of Scent on Pregnancy Induced Nausea, Vomiting, and Quality of Life
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
April 15, 2018 (Actual)
Primary Completion Date
August 1, 2019 (Actual)
Study Completion Date
March 29, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Franklin Health Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morning Sickness, Pregnancy Early
Keywords
Aromatherapy, Essential Oils
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention 1
Arm Type
Experimental
Arm Description
The women in this arm will receive the Citrus-Based Aromatherapy product to apply regularly for 6 days.
Arm Title
Intervention 2
Arm Type
Experimental
Arm Description
The women in this arm will receive the Mint-Based Aromatherapy product to apply regularly for 6 days.
Arm Title
Intervention 3
Arm Type
Experimental
Arm Description
The women in this arm will receive the Spice-Scented Aromatherapy product to apply regularly for 6 days.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
The women in this arm will receive a vegetable oil roll-on product to apply regularly for 6 days.
Intervention Type
Other
Intervention Name(s)
Citrus-Based Aromatherapy
Intervention Description
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
Intervention Name(s)
Mint-Based Aromatherapy
Intervention Description
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
Intervention Name(s)
Spice-Scented Aromatherapy
Intervention Description
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
Intervention Name(s)
Control
Intervention Description
This control is a blend of plant derived oils which have been expressed from crude plant matter.
Primary Outcome Measure Information:
Title
Change from Nausea and Vomiting 6-part Quantification of Emesis scale
Description
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.
Time Frame
daily for 6 days
Secondary Outcome Measure Information:
Title
Health Related Quality of Life for Nausea and Vomiting of Pregnancy 30-part scale
Description
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.
Time Frame
baseline and day 6
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
age: 18-45 years
confirmed pregnancy
healthy pregnancy
Exclusion Criteria:
hyperemesis gravidarum
tobacco use in the home
high risk pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessie Hawkins, PhD
Organizational Affiliation
Franklin Health Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Franklin Institute of Wellness
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
no plan to share
Learn more about this trial
The Effect of Scent on Pregnancy Induced Nausea, Vomiting, and Quality of Life
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