Back to resultsLavender Aromatherapy Spine Procedure Study
Primary Purpose
Spine Injuries and Disorders, Pain, Back
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Activated Lavender Elequil aromatabs® (#372)
Unactivated Lavender Elequil aromatabs® (#372)
Sponsored by
About this trial
This is an interventional treatment trial for Spine Injuries and Disorders focused on measuring aromatherapy, lavender, anxiety, spine intervention
Eligibility Criteria
Inclusion Criteria:
- Males and females between 18-85 years old
Scheduled for one of the following procedures on the day of consent:
- Epidural steroid injection (ESI)
- Medial branch block (MBB)
- Radiofrequency ablation (RFA)
- Able to provide informed consent
Exclusion Criteria:
- History of anxiety disorder
- Currently on anxiolytic therapy
- Poor sense of smell
- Allergy/aversion to aromatherapy
- Non-English speaking
Sites / Locations
- Weill Cornell Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Treatment (+aromatherapy) group
Control (-aromatherapy) group
Arm Description
Outcomes
Primary Outcome Measures
Change in Subjects' Anxiety State as measured by the State Trait Anxiety Inventory (STAI-6)
The STAI-6 is a six-item assessment of state anxiety. Each item is assessed on a four-point Likert scale. Scores on the STAI-6 range from 6-24, with a higher score indicating greater state anxiety.
Secondary Outcome Measures
Number of Vasovagal Events during Standard of Care Spine Procedure
All vasovagal events that occur during the standard of care spine procedure will be recorded and reported
Number of Aborted Standard of Care Spine Procedures
Full Information
NCT ID
NCT04156009
First Posted
November 1, 2019
Last Updated
January 31, 2021
Sponsor
Weill Medical College of Cornell University
1. Study Identification
Unique Protocol Identification Number
NCT04156009
Brief Title
Lavender Aromatherapy Spine Procedure Study
Official Title
Aromatherapy for Procedural Anxiety in Pain Management and Interventional Spine Procedures
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
January 29, 2020 (Actual)
Primary Completion Date
November 18, 2020 (Actual)
Study Completion Date
November 18, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
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
Patient anxiety prior to invasive procedures poses a significant barrier to successful treatment if not well-managed. The purpose of this study is to evaluate lavender aromatherapy, a non-sedating alternative, to reduce anxiety prior to interventional spinal procedures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spine Injuries and Disorders, Pain, Back
Keywords
aromatherapy, lavender, anxiety, spine intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
For the treatment group, the aromatherapy tablets will be activated for max aromatherapy. For the control group, the tablets will not be activated and will be devoid of scent. For both groups, the tablet will be wrapped in masking tape to maintain the blind for subjects.
Allocation
Randomized
Enrollment
109 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment (+aromatherapy) group
Arm Type
Experimental
Arm Title
Control (-aromatherapy) group
Arm Type
Sham Comparator
Intervention Type
Other
Intervention Name(s)
Activated Lavender Elequil aromatabs® (#372)
Intervention Description
Activated Lavender aromatherapy tablets wrapped in tape
Intervention Type
Other
Intervention Name(s)
Unactivated Lavender Elequil aromatabs® (#372)
Intervention Description
Unactivated Lavender aromatherapy tablets wrapped in tape
Primary Outcome Measure Information:
Title
Change in Subjects' Anxiety State as measured by the State Trait Anxiety Inventory (STAI-6)
Description
The STAI-6 is a six-item assessment of state anxiety. Each item is assessed on a four-point Likert scale. Scores on the STAI-6 range from 6-24, with a higher score indicating greater state anxiety.
Time Frame
Administered within 30 minutes before and 30 minutes after intervention
Secondary Outcome Measure Information:
Title
Number of Vasovagal Events during Standard of Care Spine Procedure
Description
All vasovagal events that occur during the standard of care spine procedure will be recorded and reported
Time Frame
Assessed within 30 minutes following the standard of care spine procedure
Title
Number of Aborted Standard of Care Spine Procedures
Time Frame
Assessed within 30 minutes following standard of care spine procedure completion or abortion
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:
Males and females between 18-85 years old
Scheduled for one of the following procedures on the day of consent:
Epidural steroid injection (ESI)
Medial branch block (MBB)
Radiofrequency ablation (RFA)
Able to provide informed consent
Exclusion Criteria:
History of anxiety disorder
Currently on anxiolytic therapy
Poor sense of smell
Allergy/aversion to aromatherapy
Non-English speaking
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaspal R Singh, MD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
IPD Sharing Time Frame
Beginning 3 months and ending 5 years following article publication.
IPD Sharing Access Criteria
Researchers who provide a methodologically sound proposal to achieve aims in the approved proposal.
Learn more about this trial
Lavender Aromatherapy Spine Procedure Study
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