Anxiety Reduction During Office Procedural Medicine Using Aromatherapy

NCT04260399 | Completed

• 1 other identifier: 213113
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Anxiety; Anxiety State; Procedural Anxiety

Outcome Measures

Primary Outcomes (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.

  Immediate post-procedure

Study Arms (2)

Lavender Aromatherapy

EXPERIMENTAL

Passive exposure via an ambient essential oil diffuser to lavender aromatherapy

Other: Lavender Aromatherapy

Placebo Aromatherapy

PLACEBO COMPARATOR

Passive exposure via an ambient essential oil diffuser to saline water aromatherapy

Other: Placebo Aromatherapy

Interventions

Lavender Aromatherapy OTHER

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

Lavender Aromatherapy

Placebo Aromatherapy OTHER

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

Placebo Aromatherapy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Loyola University: lead

Study Sites (1)

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Related Publications (19)

• 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.

  PMID: 20888947 BACKGROUND

• 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.

  PMID: 14616277 BACKGROUND

• 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.

  PMID: 26386494 BACKGROUND

• 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.

  PMID: 26984467 BACKGROUND

• 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.

  PMID: 28515809 BACKGROUND

• 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.

  PMID: 30312164 BACKGROUND

• 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.

  PMID: 29516595 BACKGROUND

• 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.

  PMID: 29275402 BACKGROUND

• 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.

  PMID: 17894152 BACKGROUND

• 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.

  PMID: 17129308 BACKGROUND

• 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.

  PMID: 22464012 BACKGROUND

• 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.

  PMID: 31743795 BACKGROUND

• 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.

  PMID: 28395396 BACKGROUND

• 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.

  PMID: 27555173 BACKGROUND

• 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.

  PMID: 27157961 BACKGROUND

• Hu PH, Peng YC, Lin YT, Chang CS, Ou MC. Aromatherapy for reducing colonoscopy related procedural anxiety and physiological parameters: a randomized controlled study. Hepatogastroenterology. 2010 Sep-Oct;57(102-103):1082-6.

  PMID: 21410035 BACKGROUND

• Muzzarelli L, Force M, Sebold M. Aromatherapy and reducing preprocedural anxiety: A controlled prospective study. Gastroenterol Nurs. 2006 Nov-Dec;29(6):466-71. doi: 10.1097/00001610-200611000-00005.

  PMID: 17273013 BACKGROUND

• S PK, Aafaque S, S S, N N. Effect of Aromatherapy on Dental Anxiety Among Orthodontic Patients: A Randomized Controlled Trial. Cureus. 2019 Aug 2;11(8):e5306. doi: 10.7759/cureus.5306.

  PMID: 31592362 BACKGROUND

• Tugut N, Demirel G, Baser M, Ata EE, Karakus S. Effects of lavender scent on patients' anxiety and pain levels during gynecological examination. Complement Ther Clin Pract. 2017 Aug;28:65-69. doi: 10.1016/j.ctcp.2017.05.006. Epub 2017 May 13. No abstract available.

  PMID: 28779939 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Thythy Pham, MD

  Loyola Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This trial is not blinded
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Patients are randomized to lavender aromatherapy or saline placebo aromatherapy using a 1:1 random block allocation

Study Record Dates

• First Submitted: January 27, 2020
• First Posted: February 7, 2020
• Study Start: February 18, 2020
• Primary Completion: May 26, 2021
• Study Completion: May 26, 2021
• Last Updated: May 28, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)