Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 4 of 73 for:    aromatherapy

Aromatherapy as Treatment for n/v of Pregnancy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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

Tracking Information
First Submitted Date  ICMJE July 10, 2018
First Posted Date  ICMJE August 1, 2018
Last Update Posted Date August 1, 2018
Actual Study Start Date  ICMJE June 1, 2017
Estimated Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 31, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Aromatherapy as Treatment for n/v of Pregnancy
Official Title  ICMJE Aromatherapy as Treatment for Nausea and Vomiting of Pregnancy
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Pregnancy Emesis
Intervention  ICMJE
  • Other: Aromatherapy
    Aromatherapy using essential oils
  • Other: Placebo
    Aromatherapy using odorless placebo oil
Study Arms  ICMJE
  • Experimental: Aromatherapy
    Aromatherapy using essential oils
    Intervention: Other: Aromatherapy
  • Placebo Comparator: Placebo
    Aromatherapy using odorless placebo
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 31, 2018)
95
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2019
Estimated Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Principal Investigator 5182624942 colihas@amc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03609567
Other Study ID Numbers  ICMJE 4782
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Albany Medical College
Study Sponsor  ICMJE Albany Medical College
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Zelig Albany Medical College
PRS Account Albany Medical College
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP