Effects of Aromatherapy on Anxiety in Invasive Radiologic Procedure

March 22, 2023 updated by: Wake Forest University Health Sciences

What is the Effect of Using Aromatherapy to Reduce Anxiety in Patients Undergoing Invasive Radiologic Procedures?

The purpose of this study is to see if using aromatherapy (Lavender or Bergamot) will lower anxiety in patients having invasive Radiology procedures. First, the level of anxiety is assessed prior to the procedure using a questionnaire. Then, patients are given the aromatherapy treatment during the pre-procedure period. Then, the same questions are asked to determine how anxious the patient is after the aromatherapy and before going into the procedure room. After the procedure, patients are asked to evaluate the process of the study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 1

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Scheduled for Myelogram or IR invasive procedure at investigative site

Exclusion Criteria:

  • Incapable of giving informed consent
  • Requiring pre-medication for scheduled procedure
  • Allergy to lavender or bergamot
  • Asthma (type of breathing related condition)
  • COPD (Chronic Obstructive Pulmonary Disorder - breathing disease)
  • Respiratory issues requiring oxygen therapy

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lavender
Lavender oil
Drug: Lavender Oil
Lavender essential oil applied to cotton ball (3 drops) and placed in a medicine cup on bedside table
Other Names:
  • Lavender essential oil
  • Lavender
  • Lavender flower oil
  • Lavendula angustifolia
Experimental: Bergamot
Bergamot oil
Drug: Bergamot Oil
Bergamot essential oil applied to cotton ball (3 drops) and placed in a medicine cup on bedside table
Other Names:
  • Citrus bergamia
  • Bergamot essential oil
  • Bergamot
Placebo Comparator: Water
Other: Water
Tap water applied to cotton ball (3 drops) and placed in a medicine cup on bedside table

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety level of patients
Time Frame: Immediately prior to invasive radiologic procedure
Assessed with Amsterdam Preoperative Anxiety and Information Scale
Immediately prior to invasive radiologic procedure

Collaborators and Investigators

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

Sponsor

Wake Forest University Health Sciences

Investigators

  • Principal Investigator: Christine A Becker, PhD, Wake Forest University Health Sciences

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)

July 16, 2015

Primary Completion (Actual)

December 19, 2016

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

March 20, 2017

First Submitted That Met QC Criteria

March 20, 2017

First Posted (Actual)

March 27, 2017

Study Record Updates

Last Update Posted (Actual)

March 23, 2023

Last Update Submitted That Met QC Criteria

March 22, 2023

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04-14-09B

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

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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