Lavender Aromatherapy Spine Procedure Study

• Sponsor: Weill Medical College of Cornell University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04156009
• Collaborator: (none)
• Enrollment: 109
• Location: 1
• Arms: 2
• Actual Duration (Months): 9.7
• Patients Per Site Per Month: 11.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Spine Injuries and Disorders; Pain, Back	Other: Activated Lavender Elequil aromatabs® (#372); Other: Unactivated Lavender Elequil aromatabs® (#372)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 109 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (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.
• Primary Purpose: Treatment
• Official Title: Aromatherapy for Procedural Anxiety in Pain Management and Interventional Spine Procedures
• Actual Study Start Date: Jan 29, 2020
• Actual Primary Completion Date: Nov 18, 2020
• Actual Study Completion Date: Nov 18, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. Number of Aborted Standard of Care Spine Procedures [Assessed within 30 minutes following standard of care spine procedure completion or abortion]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts 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:

3. Epidural steroid injection (ESI)

4. Medial branch block (MBB)

5. Radiofrequency ablation (RFA)

6. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Weill Cornell Medicine	New York	New York	United States	10065

Sponsors and Collaborators

• Weill Medical College of Cornell University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Weill Medical College of Cornell University
• ClinicalTrials.gov Identifier: NCT04156009
• Other Study ID Numbers: 19-06020284
• First Posted: Nov 7, 2019
• Last Update Posted: Feb 2, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Weill Medical College of Cornell University: aromatherapy; lavender; anxiety; spine intervention
• Additional relevant MeSH terms: Back Pain

Study Results

No Results Posted as of Feb 2, 2021