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NCT02344745 · ClinicalTrials.gov registry record · NA
Lavender Aromatherapy for Anxiety During Urodynamics
A NA study of Pain and Anxiety, sponsored by University of Southern California.
- Completed
- Registry status
- NA
- Development phase
- 80
- Enrollment target
- 1
- Study location
NCT02344745 is a NA study of Pain and Anxiety that has completed, run by University of Southern California. The registered enrollment target is 80 participants, below the 304-participant average among 374 other Pain trials with a reported enrollment target (74% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02344745, a NA study of Pain and Anxiety, has completed, sponsored by University of Southern California.
- COMPLETED
- Registry status
- NA
- Development phase
- 80 participants
- Enrollment target
- 1
- Study location
Study 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.
Interventions
- OTHER Lavandula angustifolia essential oil (Aura Cacia)
- OTHER Distilled water
Study Locations (1)
California
- Los Angeles Count + USC Medical Center - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2014-10 |
| Est. Completion | 2015-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02344745
The ClinicalTrials.gov registry entry for NCT02344745 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 304-participant average among 374 other Pain trials with a reported enrollment target (74% lower). The listed sponsor is University of Southern California, which has 617 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Pain appearing as the primary indexed condition, and to 2 interventions - of which Lavandula angustifolia essential oil (Aura Cacia) is the first listed.
NCT02344745 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT02344745 about?
NCT02344745 is a clinical study titled "Lavender Aromatherapy for Anxiety During Urodynamics". 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...
What is the current status of trial NCT02344745?
This trial is currently completed. It is a NA study. The enrollment target is 80 participants. The study started on 2014-10. Estimated completion is 2015-08.
What conditions does trial NCT02344745 study?
This clinical trial studies the following conditions: Pain, Anxiety.
What interventions are being tested in trial NCT02344745?
The interventions under investigation include: Lavandula angustifolia essential oil (Aura Cacia) (OTHER), Distilled water (OTHER).
Who is sponsoring clinical trial NCT02344745?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02344745 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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