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Completed

NCT Number: NCT01809067

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Lavender sensitivity or allergy

Treatment and study plan

Lavender aromatherapy inhalers

Other

Patients will self-administer lavender aromatherapy from hand held inhalers containing lavender essential oil.

Other names: LAVENDER Essential Oil (Lavendula angustifolia)

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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.

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Allina Health System

Other

Registry information

Official study 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.

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Mar 12, 2013
Registry last updated
Sep 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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