NCT04257019

Pain, Anxiety During Interventional Spine Procedures

Completed NA Last updated 23 September 2020

What this trial tests

NA trial testing Lavender oil in Pain in 54 participants. Completed in 1 April 2020.

Timeline

1 October 2019

Primary endpoint
1 March 2020

1 April 2020

Quick facts

Lead sponsor	MetroHealth Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	54
Start date	1 October 2019
Primary completion	1 March 2020
Estimated completion	1 April 2020
Sites	1 location across United States

Drugs / interventions tested

• Lavender oil — full drug profile →
• Almond oil
• Water (WATER) — full drug profile →

Conditions studied

• Pain — all drugs for Pain →
• Low Back Pain — all drugs for Low Back Pain →
• Procedural Pain — all drugs for Procedural Pain →
• Procedural Anxiety — all drugs for Procedural Anxiety →

Sponsor

MetroHealth Medical Center

Who can join

18 and older, any sex, with Pain or Low Back Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Alleviating anxiety and taming trauma: Novel pharmacotherapeutics for anxiety disorders and posttraumatic stress disorder.
   Singewald N, Sartori SB, Reif A, Holmes A. · · 2023 · cited 40× · PMID 36623804 · DOI 10.1016/j.neuropharm.2023.109418
2. Impact of Lavender on Pain and Anxiety Levels Associated With Spine Procedures.
   Grabnar M, Roach MJ, Abd-Elsayed A, Kim C. · · 2021 · cited 7× · PMID 34984050 · DOI 10.31486/toj.21.0013