Lavender Aromatherapy for Anxiety During Urodynamics

• Sponsor: University of Southern California (Other)
• Overall Status: Completed
• CT.gov ID: NCT02344745
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 2
• Duration (Months): 10
• Patients Per Site Per Month: 8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety; Pain	Other: Lavandula angustifolia essential oil (Aura Cacia); Other: Distilled water	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Care Provider)
• Primary Purpose: Treatment
• Official Title: The Use of Lavender Aromatherapy to Decrease Women's Anxiety and Perception of Pain During Multi-channel Urodynamics Procedure
• Study Start Date: Oct 1, 2014
• Actual Primary Completion Date: Aug 1, 2015
• Actual Study Completion Date: Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Control Distilled water	Other: Distilled water; 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.
Experimental: Lavender Lavandula angustifolia essential oil (Aura Cacia)	Other: Lavandula angustifolia essential oil (Aura Cacia); 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.

Outcome Measures

Primary Outcome Measures

1. Anxiety Measured by VAS [At the time of catheter placement]

   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

1. Wong Baker Pain Scale [At the time of catheter placement]

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

2. Anxiety Measured by VAS [15 min after removal of the urodynamics catheters]

   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.

3. Wong Baker Pain Scale [15 min after removal of the urodynamics catheters]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Los Angeles Count + USC Medical Center	Los Angeles	California	United States	90033

Sponsors and Collaborators

• University of Southern California

Investigators

• Principal Investigator: Begum Ozel, M.D., University of Southern California

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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. Erratum in: J Urol. 2004 Oct;172(4 Pt 1):1548.
• Muzzarelli L, Force M, Sebold M. Aromatherapy and reducing preprocedural anxiety: A controlled prospective study. Gastroenterol Nurs. 2006 Nov-Dec;29(6):466-71.
• 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.
• 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.
• 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. Review.
• 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.
• 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.
• Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70.

• Responsible Party: Begum Ozel, Assistant Professor, University of Southern California
• ClinicalTrials.gov Identifier: NCT02344745
• Other Study ID Numbers: HS-14-00444
• First Posted: Jan 26, 2015
• Last Update Posted: Dec 16, 2016
• Last Verified: Oct 1, 2016

• Keywords provided by Begum Ozel, Assistant Professor, University of Southern California: Lavender; Aromatherapy; Urodynamics
• Additional relevant MeSH terms: Anxiety Disorders

Study Results

Participant Flow

Arm/Group Title	Control	Lavender
Arm/Group Description	Distilled water Distilled water: 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.	Lavandula angustifolia essential oil (Aura Cacia) Lavandula angustifolia essential oil (Aura Cacia): 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.
Period Title: Overall Study
STARTED	40	40
COMPLETED	38	40
NOT COMPLETED	2	0

Baseline Characteristics

Arm/Group Title	Control	Lavender	Total
Arm/Group Description	Distilled water Distilled water: 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.	Lavandula angustifolia essential oil (Aura Cacia) Lavandula angustifolia essential oil (Aura Cacia): 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.	Total of all reporting groups
Overall Participants	38	40	78
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	48.0 (7.5)	49.0 (8.0)	48.5 (7.9)
Gender (Count of Participants)
Female	38 100%	40 100%	78 100%
Male	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	37 97.4%	39 97.5%	76 97.4%
Not Hispanic or Latino	1 2.6%	1 2.5%	2 2.6%
Unknown or Not Reported	0 0%	0 0%	0 0%
Anxiety (cm) [Median (Full Range) ]
Median (Full Range) [cm]	4	5	5
Pain (units on a scale) [Median (Full Range) ]
Median (Full Range) [units on a scale]	0	0	0

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Lavender
Arm/Group Description	Distilled water Distilled water: 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.	Lavandula angustifolia essential oil (Aura Cacia) Lavandula angustifolia essential oil (Aura Cacia): 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.
Measure Participants	38	40
Median (Full Range) [cm]	4	3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control, Lavender
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.08
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Lavender
Arm/Group Description	Distilled water Distilled water: 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.	Lavandula angustifolia essential oil (Aura Cacia) Lavandula angustifolia essential oil (Aura Cacia): 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.
Measure Participants	38	40
Median (Full Range) [units on a scale]	0	0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control, Lavender
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.70
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Lavender
Arm/Group Description	Distilled water Distilled water: 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.	Lavandula angustifolia essential oil (Aura Cacia) Lavandula angustifolia essential oil (Aura Cacia): 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.
Measure Participants	38	39
Median (Full Range) [cm]	0.5	0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control, Lavender
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Lavender
Arm/Group Description	Distilled water Distilled water: 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.	Lavandula angustifolia essential oil (Aura Cacia) Lavandula angustifolia essential oil (Aura Cacia): 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.
Measure Participants	38	39
Median (Full Range) [units on a scale]	0	0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control, Lavender
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.50
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Adverse Events

Time Frame	The participants were observed for 60 minutes after administration of aromatherapy.
Arm/Group Title	Control		Lavender
Arm/Group Description	Distilled water Distilled water: 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.		Lavandula angustifolia essential oil (Aura Cacia) Lavandula angustifolia essential oil (Aura Cacia): 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.
All Cause Mortality
	Control		Lavender
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Control		Lavender
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/40 (0%)
Other (Not Including Serious) Adverse Events
	Control		Lavender
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/40 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.