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

Sponsor
Allina Health System (Other)
Overall Status
Completed
CT.gov ID
NCT01809067
Collaborator
(none)
60
1
2
3
19.9

Study Details

Study Description

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
  • Other: Lavender aromatherapy inhalers
N/A

Study Design

Study Type:
Interventional
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 :
Mar 1, 2013
Actual Primary Completion Date :
Jun 1, 2013
Actual Study Completion Date :
Jun 1, 2013

Arms and Interventions

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 Names:
  • LAVENDER Essential Oil (Lavendula angustifolia)
  • No Intervention: No aromatherapy

    No aromatherapy

    Outcome Measures

    Primary Outcome Measures

    1. Comparison between patients using aromatherapy and those without aromatherapy [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. [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 [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 [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

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • English speaking

    • Able to voluntarily provide consent

    • Undergoing elective MRI procedure

    Exclusion Criteria:
    • Lavender sensitivity or allergy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Abbott Northwestern Hospital Minneapolis Minnesota United States 55407

    Sponsors and Collaborators

    • Allina Health System

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Allina Health System
    ClinicalTrials.gov Identifier:
    NCT01809067
    Other Study ID Numbers:
    • 3887-2
    First Posted:
    Mar 12, 2013
    Last Update Posted:
    Sep 8, 2016
    Last Verified:
    Mar 1, 2013
    Keywords provided by Allina Health System
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 8, 2016