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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator | Distilled water |
|
| Lavender | Experimental | Lavandula angustifolia essential oil (Aura Cacia) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Wong Baker Pain Scale | Pain was measured on the Wong Baker scale from 0-10. Higher values indicate more pain. | At the time of catheter placement |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Begum Ozel, M.D. | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles Count + USC Medical Center | Los Angeles | California | 90033 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24707312 | Background | 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. | |
| 24280994 | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | 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. |
| FG001 | Lavender | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Full Range | cm | At the time of catheter placement |
|
The participants were observed for 60 minutes after administration of aromatherapy.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Begum Ozel, M.D. | Keck School of Medicine | 323-226-3416 | ozel@usc.edu |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| 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. |
|
| 15 min after removal of the urodynamics catheters |
| Wong Baker Pain Scale | Pain was measured on the Wong Baker scale from 0-10. Higher values indicate more pain. | 15 min after removal of the urodynamics catheters |
| 15992874 | 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. |
| 15126810 | 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. |
| 23932834 | 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. |
| 17273013 | 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. |
| 21649812 | 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. |
| 19962101 | 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. |
| 23449862 | 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. |
| 24223363 | 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. |
| 6880820 | 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. |
| 33626029 | Derived | 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. |
| Lavender |
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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Gender | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Anxiety | Anxiety was measured using a visual analogue scale, from 0-10 cm. All measurements were rounded to the nearest 0.5 cm. Since all participants had baseline anxiety, the lowest score recorded was 1. Higher values indicate more anxiety. | Median | Full Range | cm |
|
| Pain | Pain was measured on the Wong Baker scale from 0-10. Higher values indicate more pain. | Median | Full Range | units on a scale |
|
|
|
|
| Secondary | Wong Baker Pain Scale | Pain was measured on the Wong Baker scale from 0-10. Higher values indicate more pain. | Posted | Median | Full Range | units on a scale | At the time of catheter placement |
|
|
|
|
| Secondary | 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. | Posted | Median | Full Range | cm | 15 min after removal of the urodynamics catheters |
|
|
|
|
| Secondary | Wong Baker Pain Scale | Pain was measured on the Wong Baker scale from 0-10. Higher values indicate more pain. | Posted | Median | Full Range | units on a scale | 15 min after removal of the urodynamics catheters |
|
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Lavender | 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. | 0 | 40 | 0 | 40 |
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