NCT03461055

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 24, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 9, 2018

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 29, 2018

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 16, 2018

Completed
Last Updated

June 26, 2018

Status Verified

June 1, 2018

Enrollment Period

10 months

First QC Date

March 5, 2018

Last Update Submit

June 25, 2018

Conditions

Infertility, FemaleAnxiety

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Pain

    During intrauterine insemination procedure

Study Arms (2)

Lavender

EXPERIMENTAL

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

Water

PLACEBO COMPARATOR

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

Interventions

LavenderOTHER

Lavender aromatherapy

Also known as: Lavandula angustifolia
Lavender
WaterOTHER

Water

Water

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women undergoing intrauterine insemination
  • English speaking

You may not qualify if:

  • Allergy to lavender oil or its components
  • Currently using aromatherapy
  • Contraindication to intrauterine insemination
  • Contraindication to pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Infertility, FemaleAnxiety Disorders

Interventions

lavender oilWater

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertilityMental Disorders

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Officials

  • Elizabeth Stewart, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 5, 2018

First Posted

March 9, 2018

Study Start

May 24, 2017

Primary Completion

March 29, 2018

Study Completion

April 16, 2018

Last Updated

June 26, 2018

Record last verified: 2018-06

Locations

US(1)