Lavender Aromatherapy Spine Procedure Study

Pain, Back Clinical Trial

Official title:

Aromatherapy for Procedural Anxiety in Pain Management and Interventional Spine Procedures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04156009
• Other study ID #: 19-06020284
• Status: Completed
• Phase: N/A
• Start date: January 29, 2020
• Est. completion date: November 18, 2020

Study information

• Verified date: January 2021
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: November 18, 2020
• Est. primary completion date: November 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Pain, Back
• Spine Injuries and Disorders

Intervention

Other:
• Activated Lavender Elequil aromatabs® (#372)
Activated Lavender aromatherapy tablets wrapped in tape
• Unactivated Lavender Elequil aromatabs® (#372)
Unactivated Lavender aromatherapy tablets wrapped in tape

Locations

Country	Name	City	State
United States	Weill Cornell Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Number of Aborted Standard of Care Spine Procedures		Assessed within 30 minutes following standard of care spine procedure completion or abortion