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NCT03461055 Clinical Trial

Lavender During Intrauterine Insemination

Anxiety Clinical Trial

Official title:
Lavender Aromatherapy vs Placebo to Decrease Anxiety and Pain During Intrauterine Insemination (IUI).

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03461055
Other study ID # 17-001147
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 24, 2017
Est. completion date April 16, 2018

Study information
Verified date June 2018
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 62
Est. completion date April 16, 2018
Est. primary completion date March 29, 2018
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Lavender
Lavender aromatherapy
• Water
Water

Locations
Country Name City State
United States Mayo Clinic Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Anxiety Anxiety level using a standard visual analog scale. Scale is from 0-100 mm. 0 is absent anxiety. 100 mm is maximal anxiety. During intrauterine insemination procedure
Secondary Pain Pain score using Wong-Baker pain scale of 0-10. 0 being absent pain and 10 being maximal pain. During intrauterine insemination procedure
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