Lavender During Intrauterine Insemination

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

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.

Study Overview

• Status: Completed
• Conditions: Anxiety; Infertility, Female
• Intervention / Treatment: Other: Lavender; Other: Water

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
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain	Pain score using Wong-Baker pain scale of 0-10. 0 being absent pain and 10 being maximal pain.	During intrauterine insemination procedure

Collaborators and Investigators

• Sponsor: Mayo Clinic

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 24, 2017
• Primary Completion (ACTUAL): March 29, 2018
• Study Completion (ACTUAL): April 16, 2018

Study Registration Dates

• First Submitted: March 5, 2018
• First Submitted That Met QC Criteria: March 5, 2018
• First Posted (ACTUAL): March 9, 2018

Study Record Updates

• Last Update Posted (ACTUAL): June 26, 2018
• Last Update Submitted That Met QC Criteria: June 25, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility; Infertility, Female
• Other Study ID Numbers: 17-001147

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No