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Lavender Aromatherapy for Anxiety During Urodynamics

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ClinicalTrials.gov Identifier: NCT02344745
Recruitment Status : Completed
First Posted : January 26, 2015
Results First Posted : December 16, 2016
Last Update Posted : December 16, 2016
Sponsor:
Information provided by (Responsible Party):
Begum Ozel, University of Southern California

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 Not Applicable

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 Type : Interventional  (Clinical Trial)
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 : October 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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.




Primary Outcome Measures :
  1. Anxiety Measured by VAS [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 15 min after removal of the urodynamics catheters ]
    Pain was measured on the Wong Baker scale from 0-10. Higher values indicate more pain.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02344745


Locations
United States, California
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

Publications:

Responsible Party: Begum Ozel, Assistant Professor, University of Southern California
ClinicalTrials.gov Identifier: NCT02344745     History of Changes
Other Study ID Numbers: HS-14-00444
First Posted: January 26, 2015    Key Record Dates
Results First Posted: December 16, 2016
Last Update Posted: December 16, 2016
Last Verified: October 2016

Keywords provided by Begum Ozel, University of Southern California:
Lavender
Aromatherapy
Urodynamics

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders