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

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

Tracking Information

• First Submitted Date: March 4, 2013
• First Posted Date: March 12, 2013
• Last Update Posted Date: September 8, 2016
• Study Start Date: March 2013
• Actual Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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

Current Secondary Outcome Measures (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 (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: 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.

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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Anxiety

Intervention

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

• Active Comparator: Lavender Aromatherapy Inhalers
  Lavender Aromatherapy Inhalers
  Intervention: Other: Lavender aromatherapy inhalers
• No Intervention: No aromatherapy
  No aromatherapy

Publications *

• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 11, 2013): 60
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: June 2013
• Actual Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• Lavender sensitivity or allergy

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01809067
• Other Study ID Numbers: 3887-2
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Allina Health System
• Original Responsible Party: Same as current
• Current Study Sponsor: Allina Health System
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Allina Health System
• Verification Date: March 2013