Lavender Aromatherapy for Anxiety During Urodynamics

NCT02344745 | Completed Results

• 1 other identifier: HS-14-00444
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Urodynamics are performed in the evaluation of urinary incontinence in women considering surgery or who have failed conservative therapies. Urodynamic testing requires the placement of small catheters into the bladder and the vagina or rectum. Many women experience anxiety around the procedure which can affect patient satisfaction. Lavender aromatherapy has been associated with decreased anxiety in a variety of clinical situations. The purpose of this study is to determine a difference in self-reported anxiety and pain levels before, during, and after multichannel urodynamics in patients given lavender aromatherapy versus placebo. This study design is a randomized control trial. Women scheduled for urodynamic testing at the Los Angeles County University of Southern California (LAC+USC) Urogynecology clinic will be invited to participate. Participants will be randomized to the aromatherapy or the placebo group after informed consent is obtained and immediately before undergoing multichannel urodynamics. The participants will complete the Hospital Anxiety and Depression Survey (HADS) at baseline. They will be asked to rate their level of anxiety and pain before, during, and 15 min after the study using the visual analogue scale and Wong-Baker pain scale. At the end the participants will also be asked to rate their satisfaction with the visit overall. The primary endpoint is defined as anxiety immediately after catheters are placed. Data will be entered into a coded database for analysis using the independent samples t test, the Mann-Whitney U test, and the chi square test. Intention to treat analysis will be used.

Conditions

Anxiety; Pain

Keywords

Lavender; Aromatherapy; Urodynamics

Outcome Measures

Primary Outcomes (1)

• Anxiety Measured by VAS

  Anxiety was measured using a visual analogue scale, from 0-10 cm. All measurements were rounded to the nearest 0.5 cm. Higher values indicate more anxiety.

  At the time of catheter placement

Secondary Outcomes (3)

• Wong Baker Pain Scale

  At the time of catheter placement

• Anxiety Measured by VAS

  15 min after removal of the urodynamics catheters

• Wong Baker Pain Scale

  15 min after removal of the urodynamics catheters

Study Arms (2)

Control

PLACEBO COMPARATOR

Distilled water

Other: Distilled water

Lavender

EXPERIMENTAL

Lavandula angustifolia essential oil (Aura Cacia)

Other: Lavandula angustifolia essential oil (Aura Cacia)

Interventions

Lavandula angustifolia essential oil (Aura Cacia) OTHER

The participants will be instructed to take a deep breath while holding the towel with two drops of essential oil 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure.

Lavender

Distilled water OTHER

The participants will be instructed to take a deep breath while holding the towel with two drops of distilled water 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged 18 and over,
• Scheduled to undergo multichannel urodynamic study,
• Able to give informed consent,
• Able to read and write in English or Spanish,
• Anxiety score \> 0 on numerical scale at baseline

You may not qualify if:

• Any contraindication to multichannel urodynamic study (active urinary tract infection, active pelvic infection, glucosuria, severe hypertension, or any other condition that might be worsened by an uncomfortable test),
• Allergy to lavender oil, or any of its components

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

Los Angeles Count + USC Medical Center

Los Angeles, California, 90033, United States

Location

Related Publications (12)

• Stea S, Beraudi A, De Pasquale D. Essential oils for complementary treatment of surgical patients: state of the art. Evid Based Complement Alternat Med. 2014;2014:726341. doi: 10.1155/2014/726341. Epub 2014 Feb 24.

  PMID: 24707312 BACKGROUND

• Yeung JY, Eschenbacher MA, Pauls RN. Pain and embarrassment associated with urodynamic testing in women. Int Urogynecol J. 2014 May;25(5):645-50. doi: 10.1007/s00192-013-2261-1. Epub 2013 Nov 27.

  PMID: 24280994 BACKGROUND

• Yokoyama T, Nozaki K, Nose H, Inoue M, Nishiyama Y, Kumon H. Tolerability and morbidity of urodynamic testing: a questionnaire-based study. Urology. 2005 Jul;66(1):74-6. doi: 10.1016/j.urology.2005.01.027.

  PMID: 15992874 BACKGROUND

• Ku JH, Kim SW, Kim HH, Paick JS, Son H, Oh SJ. Patient experience with a urodynamic study: a prospective study in 208 patients. J Urol. 2004 Jun;171(6 Pt 1):2307-10. doi: 10.1097/01.ju.0000125144.82338.0c.

  PMID: 15126810 BACKGROUND

• Soltani R, Soheilipour S, Hajhashemi V, Asghari G, Bagheri M, Molavi M. Evaluation of the effect of aromatherapy with lavender essential oil on post-tonsillectomy pain in pediatric patients: a randomized controlled trial. Int J Pediatr Otorhinolaryngol. 2013 Sep;77(9):1579-81. doi: 10.1016/j.ijporl.2013.07.014. Epub 2013 Aug 8.

  PMID: 23932834 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

• Grunebaum LD, Murdock J, Castanedo-Tardan MP, Baumann LS. Effects of lavender olfactory input on cosmetic procedures. J Cosmet Dermatol. 2011 Jun;10(2):89-93. doi: 10.1111/j.1473-2165.2011.00554.x.

  PMID: 21649812 BACKGROUND

• Braden R, Reichow S, Halm MA. The use of the essential oil lavandin to reduce preoperative anxiety in surgical patients. J Perianesth Nurs. 2009 Dec;24(6):348-55. doi: 10.1016/j.jopan.2009.10.002.

  PMID: 19962101 BACKGROUND

• Fayazi S, Babashahi M, Rezaei M. The effect of inhalation aromatherapy on anxiety level of the patients in preoperative period. Iran J Nurs Midwifery Res. 2011 Fall;16(4):278-83.

  PMID: 23449862 BACKGROUND

• Olapour A, Behaeen K, Akhondzadeh R, Soltani F, Al Sadat Razavi F, Bekhradi R. The Effect of Inhalation of Aromatherapy Blend containing Lavender Essential Oil on Cesarean Postoperative Pain. Anesth Pain Med. 2013 Summer;3(1):203-7. doi: 10.5812/aapm.9570. Epub 2013 Jul 1.

  PMID: 24223363 BACKGROUND

• Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.

  PMID: 6880820 BACKGROUND

• Ozel BZ, Quevedo A, Jung C, Shirazi F, Dancz CE. Lavender Aromatherapy for Anxiety and Pain During Multichannel Urodynamics: A Randomized Controlled Pilot Trial. Female Pelvic Med Reconstr Surg. 2021 Nov 1;27(11):654-658. doi: 10.1097/SPV.0000000000001032.

  PMID: 33626029 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Begum Ozel, M.D.
• Organization: Keck School of Medicine

ozel@usc.edu

323-226-3416

Study Officials

• Begum Ozel, M.D.

  University of Southern California

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 7, 2015
• First Posted: January 26, 2015
• Study Start: October 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: December 16, 2016
• Results First Posted: December 16, 2016

Record last verified: 2016-10

Locations

US (1)