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Aromatherapy as Treatment for n/v of Pregnancy

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ClinicalTrials.gov Identifier: NCT03609567
Recruitment Status : Recruiting
First Posted : August 1, 2018
Last Update Posted : August 1, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Pregnancy Emesis Other: Aromatherapy Other: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 95 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Aromatherapy as Treatment for Nausea and Vomiting of Pregnancy
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03609567


Contacts
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Contact: Principal Investigator 5182624942 colihas@amc.edu

Locations
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United States, New York
Albany Medical Center Recruiting
Albany, New York, United States, 12208
Contact: Principal Investigator    518-262-4942    colihas@amc.edu   
Sponsors and Collaborators
Albany Medical College
Investigators
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Study Chair: Zelig Albany Medical College

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Responsible Party: Albany Medical College
ClinicalTrials.gov Identifier: NCT03609567     History of Changes
Other Study ID Numbers: 4782
First Posted: August 1, 2018    Key Record Dates
Last Update Posted: August 1, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No