Clincosm LogoSign in Get a demo

AROMA: Anxiety Reduction During Office Procedural Medicine Using Aromatherapy

Sponsor
Loyola University (Other)
Overall Status
Completed
CT.gov ID
NCT04260399
Collaborator
(none)
88
Enrollment
1
Location
2
Arms
15.2
Actual Duration (Months)
5.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Lavender Aromatherapy
  • Other: Placebo Aromatherapy
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
88 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Patients are randomized to lavender aromatherapy or saline placebo aromatherapy using a 1:1 random block allocationPatients 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
Primary Purpose:
Supportive Care
Official Title:
AROMA Study: Anxiety Reduction During Office Procedural Medicine Using Aromatherapy
Actual Study Start Date :
Feb 18, 2020
Actual Primary Completion Date :
May 26, 2021
Actual Study Completion Date :
May 26, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change in state trait anxiety level [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Loyola University Medical Center Maywood Illinois United States 60153

Sponsors and Collaborators

  • Loyola University

Investigators

  • Principal Investigator: Thythy Pham, MD, Loyola Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Thythy Pham, Assistant Professor, Loyola University
ClinicalTrials.gov Identifier:
NCT04260399
Other Study ID Numbers:
  • 213113
First Posted:
Feb 7, 2020
Last Update Posted:
May 28, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Anxiety Disorders

Study Results

No Results Posted as of May 28, 2021