Clinical trial NCT01809067: 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
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Keywords: stress
anxiety
MRI
aromatherapy
Lead sponsor: Allina Health System
Sponsor class: OTHER
First posted: 2013-03-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Lavender sensitivity or allergy

Primary outcomes:
measure: Comparison between patients using aromatherapy and those without aromatherapy
timeFrame: Within one hour following the MRI procedure
Secondary outcomes:
measure: The number of MRI cancellations related to patient stress and anxiety will be compared between the aromatherapy group and those without aromatherapy.
timeFrame: Up to 16 weeks
measure: Comparison between patients using aromatherapy and those without aromatherapy
timeFrame: Within one hour following the MRI procedure
measure: Comparison between patients using aromatherapy and those without aromatherapy
timeFrame: Within one hour following the MRI procedure
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital
state: Minnesota
Study officials:
affiliation: Allina Health System
name: Carol H Machemer, BSN
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.