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
About this trial
This is an interventional treatment trial for Anxiety
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
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
NCT ID
NCT03090750
First Posted
March 20, 2017
Last Updated
March 22, 2023
Sponsor
Wake Forest University Health Sciences
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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