AzTrials
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AnxietyAROMANCT04260399

Anxiety Reduction During Office Procedural Medicine Using Aromatherapy

A study testing Lavender Aromatherapy in people with Anxiety and Anxiety State, run by Loyola University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This goal of this study is to assess whether lavender aromatherapy during gynecologic and urogynecologic outpatient procedures is associated with a decrease in patient anxiety levels. Read more about this study

Who is it for?
Ages 18 to 100 years, women onlyHealthy volunteers can take part
Conditions the study is for
Anxiety, Anxiety State, Procedural Anxiety
What is being tested?
Lavender Aromatherapy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
88 participants
Where
1 siteUnited States
Study dates
18 Feb 2020to 26 May 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Women undergoing the following gynecologic/urogynecologic office procedures: colposcopy, loop electrical excision procedure (LEEP), endometrial biopsy, intrauterine device (IUD) insertion, hysteroscopy, Nexplanon removal, cystoscopy, urodynamics, botox intravesical injection, and transurethral bulking injection
  • English speaking
  • Ability to complete questionnaires

Who cannot join

  • Pregnancy
  • Allergy to lavender scent
  • Lung disease including asthma or chronic lung disease
  • Anosmia or problems related to smell
  • Chronic headaches or migraines
  • Inability to complete questionnaires

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Loyola University Medical Center

    Maywood, Illinois, 60153

Other trials in United States

About this study

Official title: AROMA Study: Anxiety Reduction During Office Procedural Medicine Using Aromatherapy

This goal of this study is to assess whether lavender aromatherapy during gynecologic and urogynecologic outpatient procedures is associated with a decrease in patient anxiety levels. Based on similar interventions in other specialties of medicine, the investigators hypothesize that patients exposed to lavender aromatherapy during their procedure will have less anxiety than those who are not exposed to lavender aromatherapy.

Read the detailed description

Patients who present to the Loyola Urogynecology office for an outpatient procedure will be invited to participate. Patients who consent to participate will be asked to complete pre-procedure questionnaires including an assessment of their level of procedural anxiety. Subsequently, patients will be randomized to receive either lavender aromatherapy or saline aromatherapy (placebo) during their procedure. Post-procedural levels of anxiety will then be assessed. Changes between pre- and post-procedural anxiety will be compared between the treatment and placebo control groups.

Being tested
Lavender Aromatherapy, Placebo Aromatherapy
Medical subject headings
Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lavender AromatherapyOther

    Participants in the experimental group will be passively exposed to lavender essential oil

  • Placebo AromatherapyOther

    Participants in the control group will be passively exposed to saline water aromatherapy

Study groups in NCT04260399
Study groupRoleWhat they receive
Lavender AromatherapyExperimentalPassive exposure via an ambient essential oil diffuser to lavender aromatherapy
Receives: Other: Lavender Aromatherapy
Placebo AromatherapyPlacebo comparatorPassive exposure via an ambient essential oil diffuser to saline water aromatherapy
Receives: Other: Placebo Aromatherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in state trait anxiety level

    Participants' change in state anxiety from pre-procedure to post-procedure will be measured using the State-Trait Anxiety Inventory (STAI-Y1). The STAI-Y1 is a 20 item questionnaire that asks participants to rate their state anxiety. The scale ranges from 20 to 80 points with higher scores indicating worse anxiety. The change score is calculated by subtracting the pre-procedure STAY-YI score from the post-procedure STAY-YI score to create a delta STAI-Y1 score.

    Measured: Immediate post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2020
  2. Study start18 Feb 2020
  3. Primary completion26 May 2021
  4. Study completion26 May 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Patients are randomized to lavender aromatherapy or saline placebo aromatherapy using a 1:1 random block allocation
Masking
None (open label)
Enrolment
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04260399
Sponsor's protocol ID
213113
Acronym
AROMA
Status last verified
May 2021
First submitted
27 Jan 2020
Last updated
28 May 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is no plan to make individual participant data (IPD) available to other researchers

Publications

  • Bailey L. Strategies for decreasing patient anxiety in the perioperative setting. AORN J. 2010 Oct;92(4):445-57; quiz 458-60. doi: 10.1016/j.aorn.2010.04.017.

    PubMed 20888947

  • Hilden M, Sidenius K, Langhoff-Roos J, Wijma B, Schei B. Women's experiences of the gynecologic examination: factors associated with discomfort. Acta Obstet Gynecol Scand. 2003 Nov;82(11):1030-6. doi: 10.1034/j.1600-0412.2003.00253.x.

    PubMed 14616277

  • Handelzalts JE, Krissi H, Levy S, Broitman M, Binyamin L, Peled Y. Multidimensional associations of pain and anxiety before and after colposcopy. Int J Gynaecol Obstet. 2015 Dec;131(3):297-300. doi: 10.1016/j.ijgo.2015.05.038. Epub 2015 Sep 6.

    PubMed 26386494

  • Seklehner S, Engelhardt PF, Remzi M, Fajkovic H, Saratlija-Novakovic Z, Skopek M, Resch I, Duvnjak M, Hruby S, Wehrberger C, Librenjak D, Hubner W, Breinl E, Riedl C. Anxiety and depression analyses of patients undergoing diagnostic cystoscopy. Qual Life Res. 2016 Sep;25(9):2307-14. doi: 10.1007/s11136-016-1264-z. Epub 2016 Mar 17.

    PubMed 26984467

  • Biardeau X, Lam O, Ba V, Campeau L, Corcos J. Prospective evaluation of anxiety, pain, and embarrassment associated with cystoscopy and urodynamic testing in clinical practice. Can Urol Assoc J. 2017 Mar-Apr;11(3-4):104-110. doi: 10.5489/cuaj.4127.

    PubMed 28515809

  • Garcia-Perdomo HA, Montealegre Cardona LM, Cordoba-Wagner MJ, Zapata-Copete JA. Music to reduce pain and anxiety in cystoscopy: a systematic review and meta-analysis. J Complement Integr Med. 2018 Oct 12;16(3):/j/jcim.2019.16.issue-3/jcim-2018-0095/jcim-2018-0095.xml. doi: 10.1515/jcim-2018-0095.

    PubMed 30312164

  • Kim JW, Kim HJ, Park YJ, Kang SG, Park JY, Bae JH, Kang SH, Park HS, Moon DG, Cheon J, Lee JG, Kim JJ, Oh MM. The effects of a heating pad on anxiety, pain, and distress during urodynamic study in the female patients with stress urinary incontinence. Neurourol Urodyn. 2018 Mar;37(3):997-1001. doi: 10.1002/nau.23326. Epub 2018 Mar 8.

    PubMed 29516595

  • Kwon WA, Lee JW, Seo HK, Oh TH, Park SC, Jeong HJ, Seo IY. Hand-Holding during Cystoscopy Decreases Patient Anxiety, Pain, and Dissatisfaction: A Pilot Randomized Controlled Trial. Urol Int. 2018;100(2):222-227. doi: 10.1159/000485745. Epub 2017 Dec 22.

    PubMed 29275402

  • Kim JT, Ren CJ, Fielding GA, Pitti A, Kasumi T, Wajda M, Lebovits A, Bekker A. Treatment with lavender aromatherapy in the post-anesthesia care unit reduces opioid requirements of morbidly obese patients undergoing laparoscopic adjustable gastric banding. Obes Surg. 2007 Jul;17(7):920-5. doi: 10.1007/s11695-007-9170-7.

    PubMed 17894152

  • Kim JT, Wajda M, Cuff G, Serota D, Schlame M, Axelrod DM, Guth AA, Bekker AY. Evaluation of aromatherapy in treating postoperative pain: pilot study. Pain Pract. 2006 Dec;6(4):273-7. doi: 10.1111/j.1533-2500.2006.00095.x.

    PubMed 17129308

  • Perry R, Terry R, Watson LK, Ernst E. Is lavender an anxiolytic drug? A systematic review of randomised clinical trials. Phytomedicine. 2012 Jun 15;19(8-9):825-35. doi: 10.1016/j.phymed.2012.02.013. Epub 2012 Mar 29.

    PubMed 22464012

  • Kang HJ, Nam ES, Lee Y, Kim M. How Strong is the Evidence for the Anxiolytic Efficacy of Lavender?: Systematic Review and Meta-analysis of Randomized Controlled Trials. Asian Nurs Res (Korean Soc Nurs Sci). 2019 Dec;13(5):295-305. doi: 10.1016/j.anr.2019.11.003. Epub 2019 Nov 16.

    PubMed 31743795

  • Trambert R, Kowalski MO, Wu B, Mehta N, Friedman P. A Randomized Controlled Trial Provides Evidence to Support Aromatherapy to Minimize Anxiety in Women Undergoing Breast Biopsy. Worldviews Evid Based Nurs. 2017 Oct;14(5):394-402. doi: 10.1111/wvn.12229. Epub 2017 Apr 10.

    PubMed 28395396

  • Franco L, Blanck TJ, Dugan K, Kline R, Shanmugam G, Galotti A, von Bergen Granell A, Wajda M. Both lavender fleur oil and unscented oil aromatherapy reduce preoperative anxiety in breast surgery patients: a randomized trial. J Clin Anesth. 2016 Sep;33:243-9. doi: 10.1016/j.jclinane.2016.02.032. Epub 2016 May 5.

    PubMed 27555173

  • Karaman T, Karaman S, Dogru S, Tapar H, Sahin A, Suren M, Arici S, Kaya Z. Evaluating the efficacy of lavender aromatherapy on peripheral venous cannulation pain and anxiety: A prospective, randomized study. Complement Ther Clin Pract. 2016 May;23:64-8. doi: 10.1016/j.ctcp.2016.03.008. Epub 2016 Mar 25.

    PubMed 27157961

Questions about this trial

What is this clinical trial studying?

A study testing Lavender Aromatherapy in people with Anxiety and Anxiety State, run by Loyola University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in state trait anxiety level (time frame: Immediate post-procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04260399, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2021.

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