Pain, Back, Spine Injuries and Disorders
Conditions
Keywords
aromatherapy, lavender, anxiety, spine intervention
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.
Interventions
OTHERActivated Lavender Elequil aromatabs® (#372)
Activated Lavender aromatherapy tablets wrapped in tape
OTHERUnactivated Lavender Elequil aromatabs® (#372)
Unactivated Lavender aromatherapy tablets wrapped in tape
Sponsors
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Males and females between 18-85 years old 2. Scheduled for one of the following procedures on the day of consent: 1. Epidural steroid injection (ESI) 2. Medial branch block (MBB) 3. Radiofrequency ablation (RFA) 3. Able to provide informed consent
Exclusion criteria
1. History of anxiety disorder 2. Currently on anxiolytic therapy 3. Poor sense of smell 4. Allergy/aversion to aromatherapy 5. Non-English speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Subjects' Anxiety State as measured by the State Trait Anxiety Inventory (STAI-6) | Administered within 30 minutes before and 30 minutes after intervention | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Vasovagal Events during Standard of Care Spine Procedure | Assessed within 30 minutes following the 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 | Assessed within 30 minutes following standard of care spine procedure completion or abortion | — |
Countries
United States
Outcome results
None listed