Lavender Aromatherapy for Anxiety During Urodynamics

Completed · Not applicable

Conditions studied: Anxiety, Pain

In brief

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.

Key facts

Study ID

NCT02344745

Run by

University of Southern California

People needed

80

Starts

2014-10-01

Expected to finish

2015-08-01

Last updated by the study team

2016-12-16

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Los Angeles Count + USC Medical Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.