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OpenTrials
Completed

NCT Number: NCT04156009

Lavender Aromatherapy Spine Procedure Study

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.

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Key information

Conditions

Spine Injuries and Disorders Anxiety Disorders Back Pain Disease Mental Disorders Neurologic Manifestations Pain Pain, Back Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Weill Cornell Medicine

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Activated Lavender Elequil aromatabs® (#372)

Other

Activated Lavender aromatherapy tablets wrapped in tape

Unactivated Lavender Elequil aromatabs® (#372)

Other

Unactivated Lavender aromatherapy tablets wrapped in tape

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Registry information

Official study title

Aromatherapy for Procedural Anxiety in Pain Management and Interventional Spine Procedures

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Nov 7, 2019
Registry last updated
Feb 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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