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NCT04257019 · ClinicalTrials.gov registry record · NA

Pain, Anxiety During Interventional Spine Procedures

A NA study, sponsored by MetroHealth Medical Center.

Completed
Registry status
NA
Development phase
54
Enrollment target

NCT04257019: Completed NA study, sponsored by MetroHealth Medical Center.

NCT04257019 is a NA study that has completed, run by MetroHealth Medical Center. The registered enrollment target is 54 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04257019, a NA study, has completed, sponsored by MetroHealth Medical Center.

COMPLETED
Registry status
NA
Development phase
54 participants
Enrollment target

Study 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.

Primary Outcome

Perception of pain, VAS

Interventions

  • OTHER Water
  • OTHER Lavender oil
  • OTHER Almond oil

Trial Details

FieldValue
Enrollment Target 54 participants
Start Date 2019-10-01
Est. Completion 2020-04-01
Phase NA
MetroHealth Medical Center

76 total trials

What the finished NCT04257019 record still lists

NCT04257019 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).

The record links to 0 conditions, and to 3 interventions - of which Water is the first listed.

NCT04257019 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04257019 about?

NCT04257019 is a clinical study titled "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 parasympa...

What is the current status of trial NCT04257019?

This trial is currently completed. It is a NA study. The enrollment target is 54 participants. The study started on 2019-10-01. Estimated completion is 2020-04-01.

What interventions are being tested in trial NCT04257019?

The interventions under investigation include: Water (OTHER), Lavender oil (OTHER), Almond oil (OTHER).

Who is sponsoring clinical trial NCT04257019?

This trial is sponsored by MetroHealth Medical Center, which has 76 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04257019's enrollment target sits among peer trials

54 1268th of 2000 higher than 730 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04257019, the US trial registry maintained by the National Library of Medicine. NCT04257019 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.