Aromatherapy as Treatment for n/v of Pregnancy
1 other identifier
interventional
17
1 country
1
Brief Summary
A double-blinded randomized controlled trial comparing essential oil aromatherapy versus placebo for treatment of first trimester nausea and vomiting of pregnancy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2017
CompletedFirst Submitted
Initial submission to the registry
July 10, 2018
CompletedFirst Posted
Study publicly available on registry
August 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2019
CompletedJuly 5, 2019
July 1, 2018
1.7 years
July 10, 2018
July 1, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Mean difference in Pregnancy-Unique Quantification of Emesis (PUQE) score
PUQE score is a validated measure of nausea and vomiting in pregnancy. It is a reliable tool used to measure the severity of nausea and vomiting of pregnancy. It is a questionnaire that measures the number of times in 24 hours a patient wretches, vomits, or feels nauseous. The minimum score is 3, and the maximum is 15. Participants will have PUQE scores calculated at baseline (during enrollment in the first trimester of pregnancy, at whatever age they are at), and after one month of aromatherapy use with either essential oils or placebo, with the mean difference from baseline compared as primary outcome. The Time Frame for participation will be from enrollment until the end of the first trimester (13th week of pregnancy), which, depending on gestational age in weeks at enrollment, may be up to 8 weeks.
First trimester of pregnancy
Study Arms (2)
Aromatherapy
EXPERIMENTALAromatherapy using essential oils
Placebo
PLACEBO COMPARATORAromatherapy using odorless placebo
Interventions
Eligibility Criteria
You may qualify if:
- Pregnancy at \<14 weeks gestation
- English-speaking
- Baseline PUQE score \>=6
You may not qualify if:
- Non-compliant with prenatal care or study procedures
- Hyperemesis gravidarum
- Allergies to perfumes, essential oils or cosmetics
- Abnormal sense of smell
- Known acute or chronic GI disease
- Asthma
- Use of prescription anti-emetics
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Albany Medical Center
Albany, New York, 12208, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Zelig
Albany Medical College
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 10, 2018
First Posted
August 1, 2018
Study Start
June 1, 2017
Primary Completion
March 1, 2019
Study Completion
March 1, 2019
Last Updated
July 5, 2019
Record last verified: 2018-07
Data Sharing
- IPD Sharing
- Will not share