Aromatherapy as Treatment for n/v of Pregnancy

Pregnancy Emesis Clinical Trial

Official title:

Aromatherapy as Treatment for Nausea and Vomiting of Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03609567
• Other study ID #: 4782
• Status: Completed
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: March 1, 2019

Study information

• Verified date: July 2018
• Source: Albany Medical College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: March 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy Emesis

Intervention

Other:
• Aromatherapy
Aromatherapy using essential oils
• Placebo
Aromatherapy using odorless placebo oil

Locations

Country	Name	City	State
United States	Albany Medical Center	Albany	New York

Sponsors (1)

Lead Sponsor	Collaborator
Albany Medical College

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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