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Lavender Aromatherapy Spine Procedure Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04156009
Recruitment Status : Enrolling by invitation
First Posted : November 7, 2019
Last Update Posted : November 7, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Spine Injuries and Disorders Pain, Back Other: Activated Lavender Elequil aromatabs® (#372) Other: Unactivated Lavender Elequil aromatabs® (#372) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 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
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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




Primary Outcome Measures :
  1. Change in Subjects' Anxiety State as measured by the State Trait Anxiety Inventory (STAI-6) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Assessed within 30 minutes following standard of care spine procedure completion or abortion ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04156009


Locations
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United States, New York
Weill Cornell Medicine
New York, New York, United States, 10065
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
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Principal Investigator: Jaspal R Singh, MD Weill Cornell Medicine

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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT04156009     History of Changes
Other Study ID Numbers: 19-06020284
First Posted: November 7, 2019    Key Record Dates
Last Update Posted: November 7, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Supporting Materials: Study Protocol
Statistical Analysis Plan (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.

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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:
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Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms