Effects of Aromatherapy on Anxiety in Invasive Radiologic... | NCT03090750

Studies
Effects of Aromatherapy on Anxiety in Invasive Radiologic Procedure

NCT03090750

Sponsor

Wake Forest University Health Sciences

Status

Completed

Last Update Posted

Mar 23, 2023Actual

Enrollment

31Actual

Phase

Phase 1

Conditions

Anxiety
Anxiety Preoperative

Interventions

Lavender Oil
Bergamot Oil
Water

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 16, 2015Actual

Primary Completion Date

Dec 19, 2016Actual

Completion Date

Mar 2017Actual

First Submitted Date

Mar 20, 2017

First Submission Date that Met QC Criteria

Mar 20, 2017

First Posted Date

Mar 27, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 22, 2023

Last Update Posted Date

Mar 23, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

31Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lavender	Experimental	Lavender oil	Drug: Lavender Oil
Bergamot	Experimental	Bergamot oil	Drug: Bergamot Oil
Water	Placebo Comparator	Water	Other: Water

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lavender Oil	Drug	Lavender essential oil applied to cotton ball (3 drops) and placed in a medicine cup on bedside table	Lavender

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Anxiety level of patients	Assessed with Amsterdam Preoperative Anxiety and Information Scale	Immediately prior to invasive radiologic procedure

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Scheduled for Myelogram or IR invasive procedure at investigative site

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christine A Becker, PhD	Wake Forest University Health Sciences	Principal Investigator

Locations

Not provided

ID	Term
D001008	Anxiety Disorders

ID	Term
D001523	Mental Disorders

Intervention Browse Module

MeSH Terms

ID	Term
C045718	lavender oil
C068336	bergamot oil
D014867	Water

Ancestor Terms

ID	Term
D006878	Hydroxides
D000468	Alkalies
D007287	Inorganic Chemicals
D000838	Anions
D007477

Browse Leaves

Not provided

Browse Branches

Not provided