Clinical Trial

Pain, Anxiety During Interventional Spine Procedures

Study Description

Pain, Anxiety During Interventional Spine Procedures

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.

Location

Locations Selected Location

Methods

No pharmaceutical medication involved No pharmaceutical medication involved
Patients and healthy individuals accepted Patients and healthy individuals accepted

Lavender oil

Inhalation of Lavender oil

Almond oil

Inhalation of Almond oil

Water

Inhalation of water

Additional Information

Official Study Title

Assessing the Effect of Lavender on Pain and Anxiety Levels During Interventional Spine Procedures Under Fluoroscopy

Clinical Trial ID

NCT04257019

ParticipAid ID

ejREze