The Effects of Lavender Aromatherapy on Reducing Stress and Anxiety During MRI Procedures.
Primary Purpose
Anxiety
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lavender aromatherapy inhalers
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety focused on measuring stress, anxiety, MRI, aromatherapy
Eligibility Criteria
Inclusion Criteria:
- English speaking
- Able to voluntarily provide consent
- Undergoing elective MRI procedure
Exclusion Criteria:
- Lavender sensitivity or allergy
Sites / Locations
- Abbott Northwestern Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Lavender Aromatherapy Inhalers
No aromatherapy
Arm Description
Lavender Aromatherapy Inhalers
No aromatherapy
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
The number of MRI cancellations related to patient stress and anxiety will be compared between the aromatherapy group and those without aromatherapy.
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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01809067
Brief Title
The Effects of Lavender Aromatherapy on Reducing Stress and Anxiety During MRI Procedures.
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 Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allina Health System
4. Oversight
Data Monitoring Committee
No
5. 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:
The use of lavender aromatherapy will reduce anxiety by 20% during MRI procedures.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
Keywords
stress, anxiety, MRI, aromatherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lavender Aromatherapy Inhalers
Arm Type
Active Comparator
Arm Description
Lavender Aromatherapy Inhalers
Arm Title
No aromatherapy
Arm Type
No Intervention
Arm Description
No aromatherapy
Intervention Type
Other
Intervention Name(s)
Lavender aromatherapy inhalers
Other Intervention Name(s)
LAVENDER Essential Oil (Lavendula angustifolia)
Intervention Description
Patients will self-administer lavender aromatherapy from hand held inhalers containing lavender essential oil.
Primary Outcome Measure Information:
Title
Comparison between patients using aromatherapy and those without aromatherapy
Description
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)
Time Frame
Within one hour following the MRI procedure
Secondary Outcome Measure Information:
Title
The number of MRI cancellations related to patient stress and anxiety will be compared between the aromatherapy group and those without aromatherapy.
Description
A simple comparison will be made using the percentage of cancellations in each group of patients, the group using aromatherapy and those without aromatherapy.
Time Frame
Up to 16 weeks
Title
Comparison between patients using aromatherapy and those without aromatherapy
Description
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
Time Frame
Within one hour following the MRI procedure
Title
Comparison between patients using aromatherapy and those without aromatherapy
Description
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
Time Frame
Within one hour following the MRI procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
English speaking
Able to voluntarily provide consent
Undergoing elective MRI procedure
Exclusion Criteria:
Lavender sensitivity or allergy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carol H Machemer, BSN
Organizational Affiliation
Allina Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abbott Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
15194514
Citation
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.
Results Reference
background
PubMed Identifier
19125379
Citation
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.
Results Reference
background
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The Effects of Lavender Aromatherapy on Reducing Stress and Anxiety During MRI Procedures.
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