Back to resultsAromatherapy Effect on Anxiety Prior to Interventional Spine Procedures
Primary Purpose
Anxiety State
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aromatherapy
Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Anxiety State
Eligibility Criteria
Inclusion Criteria: Participants undergoing medial branch block, radiofrequency ablation, or epidural steroid injections Proficient with English. Exclusion Criteria: Patients with a history of anxiety disorders, currently on anxiolytic therapy Those with significantly impaired sense of smell Allergy/aversion to lavender essential oils Patients with asthma Patients with history of migraines Patients with any other condition that, in the opinion of the investigator, would compromise the well-being of the patient or prevent the patient from meeting or performing study requirements Adults unable to consent Individuals who are not yet adults Pregnant women Prisoners
Sites / Locations
- University of Miami HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Aromatherapy group
Placebo group
Arm Description
Participants in this group will receive, lavender essential oil applied to their surgical mask for 5 minutes prior to scheduled standard of care interventional spine procedure.
Participants in this group will receive water applied to their surgical mask for 5 minutes prior to scheduled standard of care interventional spine procedure.
Outcomes
Primary Outcome Measures
Anxiety state as measured by VASA
The Visual Analogue Scale for Anxiety (VASA) has scales ranging from 0 indicating "no anxiety" to 10 indicating "high anxiety"
Secondary Outcome Measures
Number of participants experiencing vasovagal syncope
Number of participants experiencing vasovagal syncope during the interventional procedure post aromatherapy/ placebo will be collected via chart review
Number of participants with an aborted interventional spine procedure
Number of participants with an aborted interventional spine procedure due to intolerance
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05660486
Brief Title
Aromatherapy Effect on Anxiety Prior to Interventional Spine Procedures
Official Title
The Effect of Aromatherapy on Anxiety Prior to Interventional Spine Procedures: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of this study is to evaluate the effect of lavender essential oil on pre-procedure anxiety for patients undergoing interventional spine procedures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety State
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Aromatherapy group
Arm Type
Experimental
Arm Description
Participants in this group will receive, lavender essential oil applied to their surgical mask for 5 minutes prior to scheduled standard of care interventional spine procedure.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Participants in this group will receive water applied to their surgical mask for 5 minutes prior to scheduled standard of care interventional spine procedure.
Intervention Type
Other
Intervention Name(s)
Aromatherapy
Intervention Description
Participants in this group will receive 2-3 drops of 100% pure Lavandula angustifolia essential oil applied to a surgical mask pre-procedure for aromatherapy.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Participants in this group will receive 2-3 drops of water applied to a surgical mask pre-procedure.
Primary Outcome Measure Information:
Title
Anxiety state as measured by VASA
Description
The Visual Analogue Scale for Anxiety (VASA) has scales ranging from 0 indicating "no anxiety" to 10 indicating "high anxiety"
Time Frame
Up to 10 minutes after aromatherapy administration
Secondary Outcome Measure Information:
Title
Number of participants experiencing vasovagal syncope
Description
Number of participants experiencing vasovagal syncope during the interventional procedure post aromatherapy/ placebo will be collected via chart review
Time Frame
Up to 30 minutes post standard of care interventional spine procedure
Title
Number of participants with an aborted interventional spine procedure
Description
Number of participants with an aborted interventional spine procedure due to intolerance
Time Frame
Up to 60 minutes post aromatherapy administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants undergoing medial branch block, radiofrequency ablation, or epidural steroid injections
Proficient with English.
Exclusion Criteria:
Patients with a history of anxiety disorders, currently on anxiolytic therapy
Those with significantly impaired sense of smell
Allergy/aversion to lavender essential oils
Patients with asthma
Patients with history of migraines
Patients with any other condition that, in the opinion of the investigator, would compromise the well-being of the patient or prevent the patient from meeting or performing study requirements
Adults unable to consent
Individuals who are not yet adults
Pregnant women
Prisoners
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jonathan Presley, MD
Phone
305 585 9600
Email
jrp184@med.miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chane Price, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33156
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Presley, MD
Phone
305-585-9600
Email
jrp184@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Chane Price, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Aromatherapy Effect on Anxiety Prior to Interventional Spine Procedures
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