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Lavender During Intrauterine Insemination

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ClinicalTrials.gov Identifier: NCT03461055
Recruitment Status : Recruiting
First Posted : March 9, 2018
Last Update Posted : April 2, 2018
Sponsor:
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 Phase
Infertility, Female Anxiety Other: Lavender Other: Water Not Applicable

Detailed Description:
Infertility patients have a high level of anxiety before and during infertility treatments due to anticipated discomfort of a procedure and anticipation of a long awaited pregnancy. Aromatherapy with lavender, an essential oil, has been shown to be effective in reducing anxiety and pain in a variety of procedures such as Botox injections, cesarean delivery and intrauterine device placement.

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

Arm Intervention/treatment
Experimental: Lavender
Lavandula angustifolia aromatherapy. 1 drop on a cotton ball placed in a porous pouch. Given to patients at the time of their intrauterine insemination.
Other: Lavender
Lavender aromatherapy
Other Name: Lavandula angustifolia

Placebo Comparator: Water
1 drop of water on a cotton ball placed in a porous pouch. Given to patients at the time of their intrauterine insemination.
Other: Water
Water




Primary Outcome Measures :
  1. Anxiety [ Time Frame: During intrauterine insemination procedure ]
    Anxiety level using a standard visual analog scale. Scale is from 0-100 mm. 0 is absent anxiety. 100 mm is maximal anxiety.


Secondary Outcome Measures :
  1. Pain [ Time Frame: During intrauterine insemination procedure ]
    Pain score using Wong-Baker pain scale of 0-10. 0 being absent pain and 10 being maximal pain.



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

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 ClinicalTrials.gov identifier (NCT number): NCT03461055


Contacts
Contact: Tiffanny L Jones, MD 507-284-4520 jones.tiffanny@mayo.edu
Contact: Elizabeth A Stewart 507-284-4520 stewart.elizabeth@mayo.edu

Locations
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
Investigators
Principal Investigator: Elizabeth Stewart, MD Mayo Clinic

Responsible Party: Elizabeth A. Stewart, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03461055     History of Changes
Other Study ID Numbers: 17-001147
First Posted: March 9, 2018    Key Record Dates
Last Update Posted: April 2, 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
Infertility, Female
Genital Diseases, Male
Genital Diseases, Female