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Pain, Anxiety During Interventional Spine Procedures

Primary Purpose

Pain, Low Back Pain, Procedural Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lavender oil
Almond oil
Water
Sponsored by
MetroHealth Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring lavender, procedural pain, patient experience

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. patients who are undergoing lumbar epidural steroid injections or lumbar medial branch blocks
  2. Age 21 or older

Exclusion Criteria:

  1. An allergy or sensitivity to lavender or almond oil
  2. A pre-existing problem with the sense of smell
  3. A subject unable to follow basic instructions relating to the design of the experiment, or subjects unable to answer questions regarding their pain or anxiety

Sites / Locations

  • MetroHealth

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Sham Comparator

Arm Label

Lavender

Almond

Water

Arm Description

Lavender mask before and during procedure

Almond oil mask before and during procedure

Water mask before and during procedure

Outcomes

Primary Outcome Measures

Pain perception
Perception of pain, VAS

Secondary Outcome Measures

Anxiety
Anxiety related to procedure

Full Information

First Posted
February 1, 2020
Last Updated
September 21, 2020
Sponsor
MetroHealth Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04257019
Brief Title
Pain, Anxiety During Interventional Spine Procedures
Official Title
Assessing the Effect of Lavender on Pain and Anxiety Levels During Interventional Spine Procedures Under Fluoroscopy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
April 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
MetroHealth Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Lavender is a plant whose extracts are widely used in aromatherapy. Lavender has been shown to decrease pain during procedures, and has also been shown to decrease pre-operative anxiety. It contains two compounds, linalool and linalyl acetate, both of which have been shown to stimulate the parasympathetic nervous system. The study will be conducted to evaluate the effect of inhaled lavender on pain and anxiety levels associated with specific interventional pain procedures. The study will be conducted in a randomized controlled trial. The trial will include one experimental group who will be exposed to lavender oil infused surgical mask to be worn by the subject, a second placebo group who will be exposed to a almond oil infused surgical mask to be worn, and a third control group who will wear a surgical mask infused with sterile water. Participants will be randomly assigned, and subject will be blinded. Our study will seek at least sixty participants, each randomly assigned either the experimental, placebo, or control group (n=20) to ensure adequate power. The disease characteristics among groups will be similar, with all participants experiencing back pain with or without radicular symptoms leading them to seek lumbar epidural steroid injection or lumbar medial branch block. Pre-procedural anxiety and anxiety occurring during the procedure will be measured by the State Trait Anxiety Inventory (STAT-I) questionnaire. Procedural pain will be measured using the Visual Analogue Scale (VAS). Our goal with this study is to investigate safe, adjunctive therapies that may decrease patient discomfort during interventional pain procedures, and ultimately improve procedural adherence.
Detailed Description
Interventional spine procedures such as lumbar epidural steroid injections and nerve blocks can be painful or anxiety provoking for patients. It is paramount to reduce pain and anxiety as much as possible during these procedures, since doing so improves patient satisfaction and compliance. Lavender is a plant whose extracts are widely used in aromatherapy. Aromatherapy is defined as the therapeutic use of essential oils derived from plants. Lavender aromatherapy has been reported to possess several therapeutic effects including anti-anxiety, sedation, mood stabilization, and analgesia. Situational anxiety, such as that relating to procedures, along with procedural pain, can be particularly uncomfortable for patients. The current short-acting anxiolytic agents like benzodiazepines and pain-relieving opiates are associated with numerous side effects such as drug tolerance, abuse and sedation. Consequently, it is important to discover an alternative therapy to relieve anxiety and pain. Lavender has been shown to decrease anxiety in patients scheduled to undergo colorectal surgery and has been shown to decrease anxiety associated with dental procedures. Lavender has also been shown to decrease pain during procedures, particularly when inhaled prior to a generally painful procedure such as catheter or needle insertion, or chest tube removal. Two basic mechanisms may explain the effects of lavender therapy. First is the influence of aroma on the brain through the limbic system via olfaction, and the other is through the direct pharmacological effects of the essential oil. Lavender contains two compounds, linalool and linalyl acetate, both of which have been shown to stimulate the parasympathetic nervous system. In recent animal models, linalyl acetate anxiolytic effects were not observed in anosmic mice, indicating that the effects were triggered by olfactory input. In addition, it was found that flumazenil antagonized odor-induced anxiolytic effects, indicating that GABAergic transmission plays an important role in anxiolytic effects. It is well known that anxiety can alter the course of pain. Studies show that the emotional and behavioral responses to pain are strongly guided by two related psychosocial factors, fear and anxiety. Individuals who have lower anxiety do not interpret pain as negatively, which aids in recovery. This study seeks to investigate whether lavender essential oil reduces pain and anxiety during interventional spine procedures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Low Back Pain, Procedural Pain, Procedural Anxiety
Keywords
lavender, procedural pain, patient experience

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lavender
Arm Type
Experimental
Arm Description
Lavender mask before and during procedure
Arm Title
Almond
Arm Type
Active Comparator
Arm Description
Almond oil mask before and during procedure
Arm Title
Water
Arm Type
Sham Comparator
Arm Description
Water mask before and during procedure
Intervention Type
Other
Intervention Name(s)
Lavender oil
Intervention Description
Inhalation of Lavender oil
Intervention Type
Other
Intervention Name(s)
Almond oil
Intervention Description
Inhalation of Almond oil
Intervention Type
Other
Intervention Name(s)
Water
Intervention Description
Inhalation of water
Primary Outcome Measure Information:
Title
Pain perception
Description
Perception of pain, VAS
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Anxiety
Description
Anxiety related to procedure
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: patients who are undergoing lumbar epidural steroid injections or lumbar medial branch blocks Age 21 or older Exclusion Criteria: An allergy or sensitivity to lavender or almond oil A pre-existing problem with the sense of smell A subject unable to follow basic instructions relating to the design of the experiment, or subjects unable to answer questions regarding their pain or anxiety
Facility Information:
Facility Name
MetroHealth
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Pain, Anxiety During Interventional Spine Procedures

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