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

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ClinicalTrials.gov Identifier: NCT01809067
Recruitment Status : Completed
First Posted : March 12, 2013
Last Update Posted : September 8, 2016
Sponsor:
Information provided by (Responsible Party):
Allina Health System

Study Description
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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. 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.


Condition or disease Intervention/treatment Phase
Anxiety Other: Lavender aromatherapy inhalers Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : March 2013
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Lavender Aromatherapy Inhalers
Lavender Aromatherapy Inhalers
 Other: Lavender aromatherapy inhalers
Patients will self-administer lavender aromatherapy from hand held inhalers containing lavender essential oil.
Other Name: LAVENDER Essential Oil (Lavendula angustifolia)
No Intervention: No aromatherapy
No aromatherapy


Outcome Measures
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Primary Outcome Measures :
  1. 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)



Secondary Outcome Measures :
  1. 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.

  2. 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


  3. 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



Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Lavender sensitivity or allergy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01809067


Locations
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United States, Minnesota
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Sponsors and Collaborators
Allina Health System
Investigators
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Principal Investigator: Carol H Machemer, BSN Allina Health System
More Information
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Publications:

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Responsible Party: Allina Health System
ClinicalTrials.gov Identifier: NCT01809067    
Other Study ID Numbers: 3887-2
First Posted: March 12, 2013    Key Record Dates
Last Update Posted: September 8, 2016
Last Verified: March 2013
Keywords provided by Allina Health System:
stress
anxiety
MRI
aromatherapy
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders