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Anxiety Reduction During Office Procedural Medicine Using Aromatherapy (AROMA)

Primary Purpose

Anxiety, Anxiety State, Procedural Anxiety

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lavender Aromatherapy
Placebo Aromatherapy
Sponsored by
Loyola University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anxiety

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Loyola University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lavender Aromatherapy

Placebo Aromatherapy

Arm Description

Passive exposure via an ambient essential oil diffuser to lavender aromatherapy

Passive exposure via an ambient essential oil diffuser to saline water aromatherapy

Outcomes

Primary Outcome Measures

Change in state trait anxiety level
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.

Secondary Outcome Measures

Full Information

First Posted
January 27, 2020
Last Updated
May 27, 2021
Sponsor
Loyola University
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1. Study Identification

Unique Protocol Identification Number
NCT04260399
Brief Title
Anxiety Reduction During Office Procedural Medicine Using Aromatherapy
Acronym
AROMA
Official Title
AROMA Study: Anxiety Reduction During Office Procedural Medicine Using Aromatherapy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
February 18, 2020 (Actual)
Primary Completion Date
May 26, 2021 (Actual)
Study Completion Date
May 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loyola University

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
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Anxiety State, Procedural Anxiety

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients are randomized to lavender aromatherapy or saline placebo aromatherapy using a 1:1 random block allocation
Masking
None (Open Label)
Masking Description
This trial is not blinded
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lavender Aromatherapy
Arm Type
Experimental
Arm Description
Passive exposure via an ambient essential oil diffuser to lavender aromatherapy
Arm Title
Placebo Aromatherapy
Arm Type
Placebo Comparator
Arm Description
Passive exposure via an ambient essential oil diffuser to saline water aromatherapy
Intervention Type
Other
Intervention Name(s)
Lavender Aromatherapy
Intervention Description
Participants in the experimental group will be passively exposed to lavender essential oil
Intervention Type
Other
Intervention Name(s)
Placebo Aromatherapy
Intervention Description
Participants in the control group will be passively exposed to saline water aromatherapy
Primary Outcome Measure Information:
Title
Change in state trait anxiety level
Description
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.
Time Frame
Immediate post-procedure

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thythy Pham, MD
Organizational Affiliation
Loyola Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make individual participant data (IPD) available to other researchers
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Anxiety Reduction During Office Procedural Medicine Using Aromatherapy

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