NCT03090750

Brief Summary

The purpose of this study is to see if using aromatherapy (Lavender or Bergamot) will lower anxiety in patients having invasive Radiology procedures. First, the level of anxiety is assessed prior to the procedure using a questionnaire. Then, patients are given the aromatherapy treatment during the pre-procedure period. Then, the same questions are asked to determine how anxious the patient is after the aromatherapy and before going into the procedure room. After the procedure, patients are asked to evaluate the process of the study.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for phase_1 anxiety

Timeline
Completed

Started Jul 2015

Typical duration for phase_1 anxiety

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 16, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

March 20, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 27, 2017

Completed
Last Updated

March 23, 2023

Status Verified

March 1, 2018

Enrollment Period

1.4 years

First QC Date

March 20, 2017

Last Update Submit

March 22, 2023

Conditions

AnxietyAnxiety Preoperative

Outcome Measures

Primary Outcomes (1)

  • Anxiety level of patients

    Assessed with Amsterdam Preoperative Anxiety and Information Scale

    Immediately prior to invasive radiologic procedure

Study Arms (3)

Lavender

EXPERIMENTAL

Lavender oil

Drug: Lavender Oil

Bergamot

EXPERIMENTAL

Bergamot oil

Drug: Bergamot Oil

Water

PLACEBO COMPARATOR

Water

Other: Water

Interventions

Lavender OilDRUG

Lavender essential oil applied to cotton ball (3 drops) and placed in a medicine cup on bedside table

Also known as: Lavender essential oil, Lavender, Lavender flower oil, Lavendula angustifolia
Lavender
Bergamot OilDRUG

Bergamot essential oil applied to cotton ball (3 drops) and placed in a medicine cup on bedside table

Also known as: Bergamot essential oil, Bergamot, Citrus bergamia
Bergamot
WaterOTHER

Tap water applied to cotton ball (3 drops) and placed in a medicine cup on bedside table

Water

Eligibility Criteria

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

You may qualify if:

  • Scheduled for Myelogram or IR invasive procedure at investigative site

You may not qualify if:

  • Incapable of giving informed consent
  • Requiring pre-medication for scheduled procedure
  • Allergy to lavender or bergamot
  • Asthma (type of breathing related condition)
  • COPD (Chronic Obstructive Pulmonary Disorder - breathing disease)
  • Respiratory issues requiring oxygen therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Anxiety Disorders

Interventions

lavender oilbergamot oilWater

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Officials

  • Christine A Becker, PhD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2017

First Posted

March 27, 2017

Study Start

July 16, 2015

Primary Completion

December 19, 2016

Study Completion

March 1, 2017

Last Updated

March 23, 2023

Record last verified: 2018-03