Morning SicknessNCT03513536
The Effect of Scent on Pregnancy Induced Nausea, Vomiting, and Quality of Life
A study testing Citrus-Based Aromatherapy, Mint-Based Aromatherapy and Spice-Scented Aromatherapy in people with Morning Sickness and Pregnancy Early, run by Nutraceuticals Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Morning Sickness, Pregnancy Early
- What is being tested?
- Citrus-Based Aromatherapy, Mint-Based Aromatherapy and Spice-Scented Aromatherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2018to 29 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- age: 18-45 years
- confirmed pregnancy
- healthy pregnancy
Who cannot join
- hyperemesis gravidarum
- tobacco use in the home
- high risk pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Franklin Institute of Wellness
Franklin, Tennessee, 37067
About this study
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.
Read the 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.
- Conditions
- Morning Sickness, Pregnancy Early
- Being tested
- Citrus-Based Aromatherapy, Mint-Based Aromatherapy, Spice-Scented Aromatherapy, Control
- Keywords
- Aromatherapy, Essential Oils
- Medical subject headings
- Morning Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Citrus-Based AromatherapyOther
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 AromatherapyOther
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 AromatherapyOther
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.
ControlOther
This control is a blend of plant derived oils which have been expressed from crude plant matter.
| Study group | Role | What they receive |
|---|---|---|
| Intervention 1 | Experimental | The women in this arm will receive the Citrus-Based Aromatherapy product to apply regularly for 6 days. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: daily for 6 days
Secondary outcomes (1)
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.
Measured: baseline and day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2018
- Study start15 Apr 2018
- Primary completion1 Aug 2019
- Study completion29 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morning SicknessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nutraceuticals Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jessie Hawkins, PhD, Principal investigator, Nutraceuticals Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03513536
- Sponsor's protocol ID
- 18-2300
- Status last verified
- Apr 2020
- First submitted
- 5 Apr 2018
- Last updated
- 29 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plan to share
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Scent on Pregnancy Induced Nausea, Vomiting, and Quality of Life
- ClinicalTrials.gov ID
- NCT03513536
- Acronym / sponsor ID
- 18-2300
- Conditions
- Morning Sickness, Pregnancy Early
- Keywords
- Aromatherapy, Essential Oils
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Nutraceuticals Research InstituteUniversity, hospital or other
- Study start
- 15 Apr 2018 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 29 Mar 2020 (actual)
- First posted
- 1 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Intervention 1 | Experimental | Other: Citrus-Based AromatherapyThe women in this arm will receive the Citrus-Based Aromatherapy product to apply regularly for 6 days. |
| Intervention 2 | Experimental | Other: Mint-Based AromatherapyThe women in this arm will receive the Mint-Based Aromatherapy product to apply regularly for 6 days. |
| Intervention 3 | Experimental | Other: Spice-Scented AromatherapyThe women in this arm will receive the Spice-Scented Aromatherapy product to apply regularly for 6 days. |
| Control | Placebo comparator | Other: ControlThe women in this arm will receive a vegetable oil roll-on product to apply regularly for 6 days. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age: 18-45 years
- confirmed pregnancy
- healthy pregnancy
Key exclusion criteria (3 listed)
- hyperemesis gravidarum
- tobacco use in the home
- high risk pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Citrus-Based AromatherapyThis 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. | Other | Intervention 1 |
| Mint-Based AromatherapyThis 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. | Other | Intervention 2 |
| Spice-Scented AromatherapyThis 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. | Other | Intervention 3 |
| ControlThis control is a blend of plant derived oils which have been expressed from crude plant matter. | Other | Control |
Primary outcome
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.
1 secondary outcome
Health Related Quality of Life for Nausea and Vomiting of Pregnancy 30-part scale
Time frame: baseline and day 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2020.
- Individual participant dataSharing planned: No. no plan to share
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessie Hawkins, PhD principal investigator
Nutraceuticals Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Citrus-Based Aromatherapy, Mint-Based Aromatherapy and Spice-Scented Aromatherapy in people with Morning Sickness and Pregnancy Early, run by Nutraceuticals Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Nausea and Vomiting 6-part Quantification of Emesis scale (time frame: daily for 6 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2020.