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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.
 
ClinicalTrials.gov Identifier: NCT03090750
Recruitment Status : Completed
First Posted : March 27, 2017
Last Update Posted : March 5, 2018
Sponsor:
Information provided by (Responsible Party):
Atrium Health

Tracking Information
First Submitted Date  ICMJE March 20, 2017
First Posted Date  ICMJE March 27, 2017
Last Update Posted Date March 5, 2018
Actual Study Start Date  ICMJE July 16, 2015
Actual Primary Completion Date December 19, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2017)
Anxiety level of patients [ Time Frame: Immediately prior to invasive radiologic procedure ]
Assessed with Amsterdam Preoperative Anxiety and Information Scale
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03090750 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Aromatherapy on Anxiety in Invasive Radiologic Procedure
Official Title  ICMJE What is the Effect of Using Aromatherapy to Reduce Anxiety in Patients Undergoing Invasive Radiologic Procedures?
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Anxiety
  • Anxiety Preoperative
Intervention  ICMJE
  • 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
  • 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
  • Other: Water
    Tap water applied to cotton ball (3 drops) and placed in a medicine cup on bedside table
Study Arms  ICMJE
  • Experimental: Lavender
    Lavender oil
    Intervention: Drug: Lavender Oil
  • Experimental: Bergamot
    Bergamot oil
    Intervention: Drug: Bergamot Oil
  • Placebo Comparator: Water
    Water
    Intervention: Other: Water
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 20, 2017)
31
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2017
Actual Primary Completion Date December 19, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03090750
Other Study ID Numbers  ICMJE 04-14-09B
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Atrium Health
Study Sponsor  ICMJE Atrium Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Atrium Health
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP