Lavender Aromatherapy Spine Procedure Study

NCT04156009 | Completed

• 1 other identifier: 19-06020284
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

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.

Conditions

Spine Injuries and Disorders; Pain, Back

Keywords

aromatherapy; lavender; anxiety; spine intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of Vasovagal Events during Standard of Care Spine Procedure

  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

Study Arms (2)

Treatment (+aromatherapy) group

EXPERIMENTAL

Other: Activated Lavender Elequil aromatabs® (#372)

Control (-aromatherapy) group

SHAM COMPARATOR

Other: Unactivated Lavender Elequil aromatabs® (#372)

Interventions

Activated Lavender Elequil aromatabs® (#372) OTHER

Activated Lavender aromatherapy tablets wrapped in tape

Treatment (+aromatherapy) group

Unactivated Lavender Elequil aromatabs® (#372) OTHER

Unactivated Lavender aromatherapy tablets wrapped in tape

Control (-aromatherapy) group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• History of anxiety disorder
• Currently on anxiolytic therapy
• Poor sense of smell
• Allergy/aversion to aromatherapy
• Non-English speaking

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Disease; Back Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Mental Disorders

Study Officials

• Jaspal R Singh, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2019
• First Posted: November 7, 2019
• Study Start: January 29, 2020
• Primary Completion: November 18, 2020
• Study Completion: November 18, 2020
• Last Updated: February 2, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal to achieve aims in the approved proposal.

Locations

US (1)