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Effects of Aromatherapy on Anxiety in Invasive Radiologic Procedure

Sponsor
Wake Forest University Health Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT03090750
Collaborator
(none)
31
Enrollment
3
Arms
19.5
Actual Duration (Months)

Study Details

Study Description

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
  • Drug: Lavender Oil
  • Drug: Bergamot Oil
  • Other: Water
 Phase 1

Study Design

Study Type:
Interventional
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 :
Jul 16, 2015
Actual Primary Completion Date :
Dec 19, 2016
Actual Study Completion Date :
Mar 1, 2017

Arms and Interventions

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

    Water

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

    Outcome Measures

    Primary Outcome Measures

    1. Anxiety level of patients [Immediately prior to invasive radiologic procedure]

      Assessed with Amsterdam Preoperative Anxiety and Information Scale

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Wake Forest University Health Sciences

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Wake Forest University Health Sciences
    ClinicalTrials.gov Identifier:
    NCT03090750
    Other Study ID Numbers:
    • 04-14-09B
    First Posted:
    Mar 27, 2017
    Last Update Posted:
    Apr 21, 2022
    Last Verified:
    Mar 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Anxiety Disorders

    Study Results

    No Results Posted as of Apr 21, 2022