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Effects of Aromatherapy on Anxiety in Invasive Radiologic Procedure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03090750
Recruitment Status : Completed
First Posted : March 27, 2017
Last Update Posted : March 5, 2018
Information provided by (Responsible Party):
Atrium Health

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Anxiety Anxiety Preoperative Drug: Lavender Oil Drug: Bergamot Oil Other: Water Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: What is the Effect of Using Aromatherapy to Reduce Anxiety in Patients Undergoing Invasive Radiologic Procedures?
Actual Study Start Date : July 16, 2015
Actual Primary Completion Date : December 19, 2016
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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:
  • Bergamot essential oil
  • Bergamot
  • Citrus bergamia

Placebo Comparator: Water
Other: Water
Tap water applied to cotton ball (3 drops) and placed in a medicine cup on bedside table

Primary Outcome Measures :
  1. Anxiety level of patients [ Time Frame: Immediately prior to invasive radiologic procedure ]
    Assessed with Amsterdam Preoperative Anxiety and Information Scale

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
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Responsible Party: Atrium Health Identifier: NCT03090750    
Other Study ID Numbers: 04-14-09B
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: March 5, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders