Trial record 6 of 1943 for:    "Mayo Clinic" [Exact]

Lavender Aromatherapy vs Placebo

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. Identifier: NCT03461055
Recruitment Status : Recruiting
First Posted : March 9, 2018
Last Update Posted : March 9, 2018
Information provided by (Responsible Party):
Elizabeth A. Stewart, Mayo Clinic

Brief Summary:
The Researchers hope to learn if by using lavender aromatherapy during an intrauterine insemination patients have decreased anxiety and pain at the time of the procedure.

Condition or disease Intervention/treatment
Infertility, Female Anxiety Other: Lavandula angustifolium Other: Water

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Lavender Aromatherapy vs Placebo to Decrease Anxiety and Pain During Intrauterine Insemination (IUI).
Actual Study Start Date : May 24, 2017
Estimated Primary Completion Date : April 16, 2018
Estimated Study Completion Date : April 16, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Lavender Other: Lavandula angustifolium
Lavender aromatherapy
Placebo Comparator: Water Other: Water

Primary Outcome Measures :
  1. Anxiety [ Time Frame: During procedure ]
    Anxiety level

  2. Pain [ Time Frame: During procedure ]
    Pain score

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Women undergoing intrauterine insemination
  • English speaking

Exclusion Criteria:

  • Allergy to lavender oil or its components
  • Currently using aromatherapy
  • Contraindication to intrauterine insemination
  • Contraindication to pregnancy

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 identifier (NCT number): NCT03461055

Contact: Tiffanny L Jones, MD 507-284-4520
Contact: Elizabeth A Stewart 507-284-4520

United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Tiffanny Jones, MD         
Principal Investigator: Elizabeth Stewart, MD         
Sponsors and Collaborators
Mayo Clinic
Principal Investigator: Elizabeth Stewart, MD Mayo Clinic

Responsible Party: Elizabeth A. Stewart, Principal Investigator, Mayo Clinic Identifier: NCT03461055     History of Changes
Other Study ID Numbers: 17-001147
First Posted: March 9, 2018    Key Record Dates
Last Update Posted: March 9, 2018
Last Verified: March 2018

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

Additional relevant MeSH terms:
Infertility, Female
Genital Diseases, Male
Genital Diseases, Female