The Effects of Lavender Aromatherapy on Reducing Stress and Anxiety During MRI Procedures.

September 7, 2016 updated by: Allina Health System

The Effects of Lavender Aromatherapy on the Reduction of Stress and Anxiety During MRI Procedures. A Randomized Study Comparing the Use of Lavender Aromatherapy to no Aromatherapy.

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

Sample size of 30 patients is needed for the control group and the lavender aromatherapy group, for a total of 60 patients.

Rationale:

Patients undergoing MRI procedures may experience stress and anxiety related to the small and confining space required during the scan. Anyone with a history of claustrophobia, panic attacks, or fear of enclosed spaces is more likely to experience symptoms of panic, fear, or anxiety during the MRI procedure (Harris, Cumming, & Menzies, 2004, p. 1). This stress and anxiety may cause the patient to abort the scan, the patient may refuse future scans, or the patient's nervous tremors or involuntary quivering may adversely affect the images obtained. Lavender aromatherapy has been shown to reduce stress and anxiety for patients in other settings; however, its use during MRI procedures has not been studied.

This project investigates the use of lavender aromatherapy as a non-pharmacological way to help patients relax during their MRI procedure. Lavender aromatherapy has been studied and shown to reduce stress and anxiety for patients in other situations, but it has not been studied during MRI procedures. Lavender is known to be uplifting, as well as soothing and helpful for reducing stress, anxiety, depression, and insomnia (Herz, 2007, p. 264). If aromatherapy proves useful as an agent to reduce stress and anxiety, patient satisfaction with their MRI procedure will increase and the need for sedating medication could decrease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Abbott Northwestern Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Lavender sensitivity or allergy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Lavender Aromatherapy Inhalers
Other: Lavender aromatherapy inhalers
Patients will self-administer lavender aromatherapy from hand held inhalers containing lavender essential oil.
Other Names:
  • LAVENDER Essential Oil (Lavendula angustifolia)
NO_INTERVENTION: No aromatherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison between patients using aromatherapy and those without aromatherapy
Time Frame: Within one hour following the MRI procedure

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of MRI cancellations related to patient stress and anxiety will be compared between the aromatherapy group and those without aromatherapy.
Time Frame: Up to 16 weeks
A simple comparison will be made using the percentage of cancellations in each group of patients, the group using aromatherapy and those without aromatherapy.
Up to 16 weeks
Comparison between patients using aromatherapy and those without aromatherapy
Time Frame: Within one hour following the MRI procedure

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.)

Perceived Stress Scale
Within one hour following the MRI procedure
Comparison between patients using aromatherapy and those without aromatherapy
Time Frame: Within one hour following the MRI procedure

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.)

Visual Analog Scale for anxiety - VAS, 0-10
Within one hour following the MRI procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allina Health System

Investigators

  • Principal Investigator: Carol H Machemer, BSN, Allina Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (ACTUAL)

June 1, 2013

Study Completion (ACTUAL)

June 1, 2013

Study Registration Dates

First Submitted

March 4, 2013

First Submitted That Met QC Criteria

March 11, 2013

First Posted (ESTIMATE)

March 12, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

September 8, 2016

Last Update Submitted That Met QC Criteria

September 7, 2016

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3887-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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