Lavender Aromatherapy for Anxiety During Urodynamics
| Status: | Completed |
|---|---|
| Conditions: | Anxiety, Chronic Pain |
| Therapuetic Areas: | Musculoskeletal, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | October 2014 |
| End Date: | August 2015 |
The Use of Lavender Aromatherapy to Decrease Women's Anxiety and Perception of Pain During Multi-channel Urodynamics Procedure
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.
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.
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.
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
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