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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

Tracking Information
First Submitted Date  ICMJE March 4, 2013
First Posted Date  ICMJE March 12, 2013
Last Update Posted Date September 8, 2016
Study Start Date  ICMJE March 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2013)
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)
Original Primary Outcome Measures  ICMJE
 (submitted: March 11, 2013)
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 these three screening tools: (Patients will complete these screening tools before and after their MRI procedure.)
  1. State Trait Anxiety Scale (State portion only - Form Y-1)
  2. Perceived Stress Scale
  3. Visual Analog Scale for anxiety - VAS, 0-10
Change History Complete list of historical versions of study NCT01809067 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 12, 2013)
  • 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.
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: March 11, 2013)
The number of MRI cancellations related to patient stress and anxiety will be compared between the aromatherapy group and those without aromatherapy. [ Time Frame: Comparison made when all patients are enrolled, total of 60 patients (30 patients per group) Anticipate enrollment will be complete by June 1, 2013 at the latest. ]
A simple comparison will be made using the percentage of cancellations in each group of patients, the group using aromatherapy and those without aromatherapy.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of Lavender Aromatherapy on Reducing Stress and Anxiety During MRI Procedures.
Official Title  ICMJE 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.
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Anxiety
Intervention  ICMJE 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)
Study Arms  ICMJE
  • Active Comparator: Lavender Aromatherapy Inhalers
    Lavender Aromatherapy Inhalers
    Intervention: Other: Lavender aromatherapy inhalers
  • No Intervention: No aromatherapy
    No aromatherapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 11, 2013)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Lavender sensitivity or allergy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01809067
Other Study ID Numbers  ICMJE 3887-2
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Allina Health System
Study Sponsor  ICMJE Allina Health System
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Carol H Machemer, BSN Allina Health System
PRS Account Allina Health System
Verification Date March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP