NCT04257019

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

September 23, 2020

Status Verified

September 1, 2020

Enrollment Period

5 months

First QC Date

February 1, 2020

Last Update Submit

September 21, 2020

Conditions

PainLow Back PainProcedural PainProcedural Anxiety

Keywords

lavenderprocedural painpatient experience

Outcome Measures

Primary Outcomes (1)

  • Pain perception

    Perception of pain, VAS

    1 day

Secondary Outcomes (1)

  • Anxiety

    1 day

Study Arms (3)

Lavender

EXPERIMENTAL

Lavender mask before and during procedure

Other: Lavender oil

Almond

ACTIVE COMPARATOR

Almond oil mask before and during procedure

Other: Almond oil

Water

SHAM COMPARATOR

Water mask before and during procedure

Other: Water

Interventions

Lavender oilOTHER

Inhalation of Lavender oil

Lavender
Almond oilOTHER

Inhalation of Almond oil

Almond
WaterOTHER

Inhalation of water

Water

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients who are undergoing lumbar epidural steroid injections or lumbar medial branch blocks
  • Age 21 or older

You may not qualify if:

  • An allergy or sensitivity to lavender or almond oil
  • A pre-existing problem with the sense of smell
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MetroHealth

Cleveland, Ohio, 44109, United States

Location

MeSH Terms

Conditions

PainLow Back PainPain, Procedural

Interventions

lavender oilalmond oilWater

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBack Pain

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

February 1, 2020

First Posted

February 5, 2020

Study Start

October 1, 2019

Primary Completion

March 1, 2020

Study Completion

April 1, 2020

Last Updated

September 23, 2020

Record last verified: 2020-09

Locations

US(1)