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Effects of Aromatherapy on Anxiety in Invasive Radiologic Procedure

Primary Purpose

Anxiety, Anxiety Preoperative

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Lavender Oil
Bergamot Oil
Water
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    Lavender

    Bergamot

    Water

    Arm Description

    Lavender oil

    Bergamot oil

    Water

    Outcomes

    Primary Outcome Measures

    Anxiety level of patients
    Assessed with Amsterdam Preoperative Anxiety and Information Scale

    Secondary Outcome Measures

    Full Information

    First Posted
    March 20, 2017
    Last Updated
    March 22, 2023
    Sponsor
    Wake Forest University Health Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03090750
    Brief Title
    Effects of Aromatherapy on Anxiety in Invasive Radiologic Procedure
    Official Title
    What is the Effect of Using Aromatherapy to Reduce Anxiety in Patients Undergoing Invasive Radiologic Procedures?
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    July 16, 2015 (Actual)
    Primary Completion Date
    December 19, 2016 (Actual)
    Study Completion Date
    March 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Wake Forest University Health Sciences

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No

    5. 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.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    31 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Lavender
    Arm Type
    Experimental
    Arm Description
    Lavender oil
    Arm Title
    Bergamot
    Arm Type
    Experimental
    Arm Description
    Bergamot oil
    Arm Title
    Water
    Arm Type
    Placebo Comparator
    Arm Description
    Water
    Intervention Type
    Drug
    Intervention Name(s)
    Lavender Oil
    Other Intervention Name(s)
    Lavender essential oil, Lavender, Lavender flower oil, Lavendula angustifolia
    Intervention Description
    Lavender essential oil applied to cotton ball (3 drops) and placed in a medicine cup on bedside table
    Intervention Type
    Drug
    Intervention Name(s)
    Bergamot Oil
    Other Intervention Name(s)
    Bergamot essential oil, Bergamot, Citrus bergamia
    Intervention Description
    Bergamot essential oil applied to cotton ball (3 drops) and placed in a medicine cup on bedside table
    Intervention Type
    Other
    Intervention Name(s)
    Water
    Intervention Description
    Tap water applied to cotton ball (3 drops) and placed in a medicine cup on bedside table
    Primary Outcome Measure Information:
    Title
    Anxiety level of patients
    Description
    Assessed with Amsterdam Preoperative Anxiety and Information Scale
    Time Frame
    Immediately prior to invasive radiologic procedure

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Christine A Becker, PhD
    Organizational Affiliation
    Wake Forest University Health Sciences
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Effects of Aromatherapy on Anxiety in Invasive Radiologic Procedure

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