Back to resultsLavender During Intrauterine Insemination
Primary Purpose
Infertility, Female, Anxiety
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lavender
Water
Sponsored by
About this trial
This is an interventional treatment trial for Infertility, Female
Eligibility 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
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Lavender
Water
Arm Description
Lavandula angustifolia aromatherapy. 1 drop on a cotton ball placed in a porous pouch. Given to patients at the time of their intrauterine insemination.
1 drop of water on a cotton ball placed in a porous pouch. Given to patients at the time of their intrauterine insemination.
Outcomes
Primary Outcome Measures
Anxiety
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
Pain
Pain score using Wong-Baker pain scale of 0-10. 0 being absent pain and 10 being maximal pain.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03461055
Brief Title
Lavender During Intrauterine Insemination
Official Title
Lavender Aromatherapy vs Placebo to Decrease Anxiety and Pain During Intrauterine Insemination (IUI).
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
May 24, 2017 (Actual)
Primary Completion Date
March 29, 2018 (Actual)
Study Completion Date
April 16, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Female, Anxiety
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lavender
Arm Type
Experimental
Arm Description
Lavandula angustifolia aromatherapy. 1 drop on a cotton ball placed in a porous pouch. Given to patients at the time of their intrauterine insemination.
Arm Title
Water
Arm Type
Placebo Comparator
Arm Description
1 drop of water on a cotton ball placed in a porous pouch. Given to patients at the time of their intrauterine insemination.
Intervention Type
Other
Intervention Name(s)
Lavender
Other Intervention Name(s)
Lavandula angustifolia
Intervention Description
Lavender aromatherapy
Intervention Type
Other
Intervention Name(s)
Water
Intervention Description
Water
Primary Outcome Measure Information:
Title
Anxiety
Description
Anxiety level using a standard visual analog scale. Scale is from 0-100 mm. 0 is absent anxiety. 100 mm is maximal anxiety.
Time Frame
During intrauterine insemination procedure
Secondary Outcome Measure Information:
Title
Pain
Description
Pain score using Wong-Baker pain scale of 0-10. 0 being absent pain and 10 being maximal pain.
Time Frame
During intrauterine insemination procedure
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Stewart, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
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Lavender During Intrauterine Insemination
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