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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03090750
Other study ID # 04-14-09B
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date July 16, 2015
Est. completion date March 2017

Study information

Verified date March 2018
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 31
Est. completion date March 2017
Est. primary completion date December 19, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Lavender Oil
Lavender essential oil applied to cotton ball (3 drops) and placed in a medicine cup on bedside table
Bergamot Oil
Bergamot essential oil applied to cotton ball (3 drops) and placed in a medicine cup on bedside table
Other:
Water
Tap water applied to cotton ball (3 drops) and placed in a medicine cup on bedside table

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Wake Forest University Health Sciences

Outcome

Type Measure Description Time frame Safety issue
Primary Anxiety level of patients Assessed with Amsterdam Preoperative Anxiety and Information Scale Immediately prior to invasive radiologic procedure
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