Pain, Anxiety During Interventional Spine Procedures

NCT ID: NCT04257019

Last Updated: 2020-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2020-04-01

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.

Conditions

Pain; Low Back Pain; Procedural Pain; Procedural Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Lavender

Lavender mask before and during procedure

Group Type: EXPERIMENTAL

Lavender oil

Intervention Type: OTHER

Inhalation of Lavender oil

Almond

Almond oil mask before and during procedure

Group Type: ACTIVE_COMPARATOR

Almond oil

Intervention Type: OTHER

Inhalation of Almond oil

Water

Water mask before and during procedure

Group Type: SHAM_COMPARATOR

Water

Intervention Type: OTHER

Inhalation of water

Interventions

Lavender oil

Inhalation of Lavender oil

Intervention Type: OTHER

Almond oil

Inhalation of Almond oil

Intervention Type: OTHER

Water

Inhalation of water

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

MetroHealth Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Chong Kim

PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

MetroHealth

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

IRB19-00512

Identifier Type: -

Identifier Source: org_study_id