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Lavender During Intrauterine Insemination

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT03461055
Collaborator
(none)
62
Enrollment
1
Location
2
Arms
10.7
Actual Duration (Months)
5.8
Patients Per Site Per Month

Study Details

Study Description

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
  • Other: Lavender
  • Other: Water
 N/A

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 Design

Study Type:
Interventional
Actual 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
Actual Primary Completion Date :
Mar 29, 2018
Actual Study Completion Date :
Apr 16, 2018

Arms and Interventions

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 Names:
  • 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

    Outcome Measures

    Primary Outcome Measures

    1. Anxiety [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 [During intrauterine insemination procedure]

      Pain score using Wong-Baker pain scale of 0-10. 0 being absent pain and 10 being maximal pain.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    • Principal Investigator: Elizabeth Stewart, MD, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Elizabeth A. Stewart, Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT03461055
    Other Study ID Numbers:
    • 17-001147
    First Posted:
    Mar 9, 2018
    Last Update Posted:
    Jun 26, 2018
    Last Verified:
    Jun 1, 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

    Study Results

    No Results Posted as of Jun 26, 2018