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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 is a NA study that has completed, run by MetroHealth Medical Center. The registered enrollment target is 54 participants.
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.
Interventions
- OTHER Water
- OTHER Lavender oil
- OTHER Almond oil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2019-10-01 |
| Est. Completion | 2020-04-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04257019
The ClinicalTrials.gov registry entry for NCT04257019 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is MetroHealth Medical Center, which has 76 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Water is the first listed.
NCT04257019 reports 0 study locations.
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.
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