Lavender Aromatherapy Spine Procedure Study

Not Applicable

Completed

• Conditions: Spine Injuries and Disorders; Pain, Back
• Interventions: Other: Unactivated Lavender Elequil aromatabs® (#372); Other: Activated Lavender Elequil aromatabs® (#372)

• Registration Number: NCT04156009
• Lead Sponsor: Weill Medical College of Cornell University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-01
• Study First Submitted QC: 2019-11-06
• Study First Posted: 2019-11-07
• Study Start: 2020-01-29
• Primary Completion: 2020-11-18
• Study Completion: 2020-11-18
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-31
• Last Update Posted: 2021-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control (-aromatherapy) group	Unactivated Lavender Elequil aromatabs® (#372)	-
Treatment (+aromatherapy) group	Activated Lavender Elequil aromatabs® (#372)	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Weill Cornell Medicine; 🇺🇸 New York, New York, United States