Anxiety Reduction During Office Procedural Medicine Using Aromatherapy (AROMA)

May 27, 2021 updated by: Thythy Pham, Loyola University

AROMA Study: Anxiety Reduction During Office Procedural Medicine Using Aromatherapy

This goal of this study is to assess whether lavender aromatherapy during gynecologic and urogynecologic outpatient procedures is associated with a decrease in patient anxiety levels. Based on similar interventions in other specialties of medicine, the investigators hypothesize that patients exposed to lavender aromatherapy during their procedure will have less anxiety than those who are not exposed to lavender aromatherapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients who present to the Loyola Urogynecology office for an outpatient procedure will be invited to participate. Patients who consent to participate will be asked to complete pre-procedure questionnaires including an assessment of their level of procedural anxiety. Subsequently, patients will be randomized to receive either lavender aromatherapy or saline aromatherapy (placebo) during their procedure. Post-procedural levels of anxiety will then be assessed. Changes between pre- and post-procedural anxiety will be compared between the treatment and placebo control groups.

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women undergoing the following gynecologic/urogynecologic office procedures: colposcopy, loop electrical excision procedure (LEEP), endometrial biopsy, intrauterine device (IUD) insertion, hysteroscopy, Nexplanon removal, cystoscopy, urodynamics, botox intravesical injection, and transurethral bulking injection
  • English speaking
  • Ability to complete questionnaires

Exclusion Criteria:

  • Pregnancy
  • Allergy to lavender scent
  • Lung disease including asthma or chronic lung disease
  • Anosmia or problems related to smell
  • Chronic headaches or migraines
  • Inability to complete questionnaires

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Lavender Aromatherapy
Passive exposure via an ambient essential oil diffuser to lavender aromatherapy
Other: Lavender Aromatherapy
Participants in the experimental group will be passively exposed to lavender essential oil
PLACEBO_COMPARATOR: Placebo Aromatherapy
Passive exposure via an ambient essential oil diffuser to saline water aromatherapy
Other: Placebo Aromatherapy
Participants in the control group will be passively exposed to saline water aromatherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in state trait anxiety level
Time Frame: Immediate post-procedure
Participants' change in state anxiety from pre-procedure to post-procedure will be measured using the State-Trait Anxiety Inventory (STAI-Y1). The STAI-Y1 is a 20 item questionnaire that asks participants to rate their state anxiety. The scale ranges from 20 to 80 points with higher scores indicating worse anxiety. The change score is calculated by subtracting the pre-procedure STAY-YI score from the post-procedure STAY-YI score to create a delta STAI-Y1 score.
Immediate post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loyola University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 18, 2020

Primary Completion (ACTUAL)

May 26, 2021

Study Completion (ACTUAL)

May 26, 2021

Study Registration Dates

First Submitted

January 27, 2020

First Submitted That Met QC Criteria

February 6, 2020

First Posted (ACTUAL)

February 7, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 28, 2021

Last Update Submitted That Met QC Criteria

May 27, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 213113

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to make individual participant data (IPD) available to other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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