NCT01809067

Brief Summary

Research Question: What effect if any does the use of lavender aromatherapy have on a patient's stress and anxiety during the MRI procedure in the Cardiovascular Services Department? Hypothesis:

  1. 1.The use of lavender aromatherapy will reduce anxiety by 20% during MRI procedures.
  2. 2.MRI cancellations related to stress and anxiety will decrease by 10%.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable anxiety

Timeline
Completed

Started Mar 2013

Shorter than P25 for not_applicable anxiety

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 12, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

September 8, 2016

Status Verified

March 1, 2013

Enrollment Period

3 months

First QC Date

March 4, 2013

Last Update Submit

September 7, 2016

Conditions

Anxiety

Keywords

stressanxietyMRIaromatherapy

Outcome Measures

Primary Outcomes (1)

  • Comparison between patients using aromatherapy and those without aromatherapy

    A comparison will be made between the two groups, one group using lavender aromatherapy and one group without aromatherapy. T-tests will be used to assess whether the two groups are statistically different from each other. Comparisons will be made by using information collected from the patient with this screening tool: (Patients will complete the screening tool before and after their MRI procedure.) State Trait Anxiety Scale (State portion only)

    Within one hour following the MRI procedure

Secondary Outcomes (3)

  • The number of MRI cancellations related to patient stress and anxiety will be compared between the aromatherapy group and those without aromatherapy.

    Up to 16 weeks

  • Comparison between patients using aromatherapy and those without aromatherapy

    Within one hour following the MRI procedure

  • Comparison between patients using aromatherapy and those without aromatherapy

    Within one hour following the MRI procedure

Study Arms (2)

Lavender Aromatherapy Inhalers

ACTIVE COMPARATOR

Lavender Aromatherapy Inhalers

Other: Lavender aromatherapy inhalers

No aromatherapy

NO INTERVENTION

No aromatherapy

Interventions

Lavender aromatherapy inhalersOTHER

Patients will self-administer lavender aromatherapy from hand held inhalers containing lavender essential oil.

Also known as: LAVENDER Essential Oil (Lavendula angustifolia)
Lavender Aromatherapy Inhalers

Eligibility Criteria

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

You may qualify if:

  • English speaking
  • Able to voluntarily provide consent
  • Undergoing elective MRI procedure

You may not qualify if:

  • Lavender sensitivity or allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

Related Publications (2)

  • Harris LM, Cumming SR, Menzies RG. Predicting anxiety in magnetic resonance imaging scans. Int J Behav Med. 2004;11(1):1-7. doi: 10.1207/s15327558ijbm1101_1.

    PMID: 15194514BACKGROUND

  • Herz RS. Aromatherapy facts and fictions: a scientific analysis of olfactory effects on mood, physiology and behavior. Int J Neurosci. 2009;119(2):263-90. doi: 10.1080/00207450802333953.

    PMID: 19125379BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Interventions

lavender oil

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Carol H Machemer, BSN

    Allina Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2013

First Posted

March 12, 2013

Study Start

March 1, 2013

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

September 8, 2016

Record last verified: 2013-03

Locations

US(1)