Lavender Aromatherapy Spine Procedure Study

Aromatherapy for Procedural Anxiety in Pain Management and Interventional Spine Procedures

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.

Study Overview

• Status: Completed
• Conditions: Spine Injuries and Disorders; Pain, Back
• Intervention / Treatment: Other: Activated Lavender Elequil aromatabs® (#372); Other: Unactivated Lavender Elequil aromatabs® (#372)

• Study Type: Interventional
• Enrollment (Actual): 109
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Weill Cornell Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Investigators: Principal Investigator: Jaspal R Singh, MD, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2020
• Primary Completion (Actual): November 18, 2020
• Study Completion (Actual): November 18, 2020

Study Registration Dates

• First Submitted: November 1, 2019
• First Submitted That Met QC Criteria: November 6, 2019
• First Posted (Actual): November 7, 2019

Study Record Updates

• Last Update Posted (Actual): February 2, 2021
• Last Update Submitted That Met QC Criteria: January 31, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: anxiety; aromatherapy; lavender; spine intervention
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Wounds and Injuries; Back Injuries; Back Pain; Spinal Injuries
• Other Study ID Numbers: 19-06020284

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No