Lavender Aromatherapy Spine Procedure Study

Study Overview
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Brief Summary
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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.

Official Title
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Aromatherapy for Procedural Anxiety in Pain Management and Interventional Spine Procedures

Conditions
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Spine Injuries and Disorders, Pain, Back

Intervention / Treatment
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* Other: Activated Lavender Elequil aromatabs® (#372)
* Other: Unactivated Lavender Elequil aromatabs® (#372)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (+aromatherapy) group<br> | Other: Activated Lavender Elequil aromatabs® (#372)<br>* Activated Lavender aromatherapy tablets wrapped in tape<br>|
| Sham Comparator: Control (-aromatherapy) group<br> | Other: Unactivated Lavender Elequil aromatabs® (#372)<br>* Unactivated Lavender aromatherapy tablets wrapped in tape<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Administered within 30 minutes before and 30 minutes after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Assessed within 30 minutes following the standard of care spine procedure | 
| Number of Aborted Standard of Care Spine Procedures |  | Assessed within 30 minutes following standard of care spine procedure completion or abortion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aromatherapy, lavender, anxiety, spine intervention