Aromatherapy as Treatment for n/v of Pregnancy

Not Applicable

Completed

• Conditions: Pregnancy Emesis
• Interventions: Other: Aromatherapy; Other: Placebo

• Registration Number: NCT03609567
• Lead Sponsor: Albany Medical College

Brief Summary

A double-blinded randomized controlled trial comparing essential oil aromatherapy versus placebo for treatment of first trimester nausea and vomiting of pregnancy.

Detailed Description

This is a double-blinded randomized controlled trial investigating the utility of essential oils for aromatherapy, compared to placebo, for treatment of nausea and vomiting in the first trimester of pregnancy.

Study Timeline

• Study Start: 2017-06-01
• Status Verified: 2018-07
• Study First Submitted: 2018-07-10
• Study First Submitted QC: 2018-07-31
• Study First Posted: 2018-08-01
• Primary Completion: 2019-03-01
• Study Completion: 2019-03-01
• Last Update Submitted: 2019-07-01
• Last Update Posted: 2019-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 17

Inclusion Criteria

• Pregnancy at <14 weeks gestation
• English-speaking
• Baseline PUQE score >=6

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aromatherapy	Aromatherapy	Aromatherapy using essential oils
Placebo	Placebo	Aromatherapy using odorless placebo

Primary Outcome Measures

Name	Time	Method
Mean difference in Pregnancy-Unique Quantification of Emesis (PUQE) score	First trimester of pregnancy	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.

Trial Locations

Locations (1)

Albany Medical Center; 🇺🇸 Albany, New York, United States