Aromatherapy as Treatment for n/v of Pregnancy

Aromatherapy as Treatment for Nausea and Vomiting of Pregnancy

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

Study Overview

• Status: Completed
• Conditions: Pregnancy Emesis
• Intervention / Treatment: Other: Aromatherapy; Other: Placebo

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 Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Aromatherapy; Aromatherapy using essential oils	Other: Aromatherapy; Aromatherapy using essential oils
PLACEBO_COMPARATOR: Placebo; Aromatherapy using odorless placebo	Other: Placebo; Aromatherapy using odorless placebo oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Albany Medical College
• Investigators: Study Chair: Zelig, Albany Medical College

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2017
• Primary Completion (ACTUAL): March 1, 2019
• Study Completion (ACTUAL): March 1, 2019

Study Registration Dates

• First Submitted: July 10, 2018
• First Submitted That Met QC Criteria: July 31, 2018
• First Posted (ACTUAL): August 1, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 5, 2019
• Last Update Submitted That Met QC Criteria: July 1, 2019
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 4782

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No