search
Back to results

Lavender Aromatherapy for Anxiety During Urodynamics

Primary Purpose

Anxiety, Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lavandula angustifolia essential oil (Aura Cacia)
Distilled water
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety focused on measuring Lavender, Aromatherapy, Urodynamics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Los Angeles Count + USC Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control

Lavender

Arm Description

Distilled water

Lavandula angustifolia essential oil (Aura Cacia)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Wong Baker Pain Scale
Pain was measured on the Wong Baker scale from 0-10. Higher values indicate more pain.
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.
Wong Baker Pain Scale
Pain was measured on the Wong Baker scale from 0-10. Higher values indicate more pain.

Full Information

First Posted
January 7, 2015
Last Updated
October 24, 2016
Sponsor
University of Southern California
search

1. Study Identification

Unique Protocol Identification Number
NCT02344745
Brief Title
Lavender Aromatherapy for Anxiety During Urodynamics
Official Title
The Use of Lavender Aromatherapy to Decrease Women's Anxiety and Perception of Pain During Multi-channel Urodynamics Procedure
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
This study design is a randomized placebo control trial. Aside from randomization to aromatherapy versus placebo, no procedures will be performed for study purposes that would not be normally performed in the clinical evaluation. Women scheduled for urodynamic testing at the Los Angeles County University of Southern California (LAC+USC) Urogynecology clinic will be invited to participate. Participants who meet inclusion criteria will be randomized to the aromatherapy or the placebo group after informed consent is obtained and immediately before undergoing multichannel urodynamics. Sequentially numbered sealed opaque envelopes containing the identity of the study arm will be used for randomization. The urogynecology clinic nurse will prepare the aromatherapy versus distilled water on the paper towel that the patient is routinely given to hold over their mouths when asked to cough during the procedure; two drops of each will be utilized. Before the physician comes in, the nurse will ask the participant to take a deep breath while holding the towel 3 inches from her face and will instruct the participant to continue to take normal breaths subsequently. It will not be possible to blind the participants or the examiner to the assigned group since the lavender oil will have a different scent than the placebo. However, the use of distilled water on the towel will allow the possibility that the deep breathing accompanying the instruction may have an effect on reported pain and anxiety. The participant will undergo the standard clinic exam in standardized order. The participants will complete the Hospital Anxiety and Depression Survey (HADS) at baseline. The HADS is reliable instrument for detecting states of depression and anxiety in the setting of a hospital medical outpatient clinic; it is available in English and Spanish versions. This will be used to establish their baseline anxiety levels. Participants will then be asked to rate their level of anxiety and pain immediately before beginning the exam, immediately after catheter placement, and 15 min after termination of the study using a 10 point visual analogue scale and the Wong-Baker pain scale.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Pain
Keywords
Lavender, Aromatherapy, Urodynamics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Distilled water
Arm Title
Lavender
Arm Type
Experimental
Arm Description
Lavandula angustifolia essential oil (Aura Cacia)
Intervention Type
Other
Intervention Name(s)
Lavandula angustifolia essential oil (Aura Cacia)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Distilled water
Intervention Description
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.
Primary Outcome Measure Information:
Title
Anxiety Measured by VAS
Description
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.
Time Frame
At the time of catheter placement
Secondary Outcome Measure Information:
Title
Wong Baker Pain Scale
Description
Pain was measured on the Wong Baker scale from 0-10. Higher values indicate more pain.
Time Frame
At the time of catheter placement
Title
Anxiety Measured by VAS
Description
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.
Time Frame
15 min after removal of the urodynamics catheters
Title
Wong Baker Pain Scale
Description
Pain was measured on the Wong Baker scale from 0-10. Higher values indicate more pain.
Time Frame
15 min after removal of the urodynamics catheters

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Begum Ozel, M.D.
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
Los Angeles Count + USC Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24707312
Citation
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.
Results Reference
background
PubMed Identifier
24280994
Citation
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.
Results Reference
background
PubMed Identifier
15992874
Citation
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.
Results Reference
background
PubMed Identifier
15126810
Citation
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. Erratum In: J Urol. 2004 Oct;172(4 Pt 1):1548.
Results Reference
background
PubMed Identifier
23932834
Citation
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.
Results Reference
background
PubMed Identifier
17273013
Citation
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.
Results Reference
background
PubMed Identifier
21649812
Citation
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.
Results Reference
background
PubMed Identifier
19962101
Citation
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.
Results Reference
background
PubMed Identifier
23449862
Citation
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.
Results Reference
background
PubMed Identifier
24223363
Citation
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.
Results Reference
background
PubMed Identifier
6880820
Citation
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.
Results Reference
background
PubMed Identifier
33626029
Citation
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.
Results Reference
derived

Learn more about this trial

Lavender Aromatherapy for Anxiety During Urodynamics

We'll reach out to this number within 24 hrs