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Completed

NCT Number: NCT03609567

Aromatherapy as Treatment for n/v of Pregnancy

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

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Key information

Conditions

Pregnancy Emesis

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Albany Medical Center

Albany, New York, 12208, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aromatherapy

Other

Aromatherapy using essential oils

Placebo

Other

Aromatherapy using odorless placebo oil

Primary outcomes

  1. Mean difference in Pregnancy-Unique Quantification of Emesis (PUQE) score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Albany Medical College

Other

Registry information

Official study title

Aromatherapy as Treatment for Nausea and Vomiting of Pregnancy

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 1, 2018
Registry last updated
Jul 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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