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Lavender Aromatherapy for Anxiety During Urodynamics

The Use of Lavender Aromatherapy to Decrease Women's Anxiety and Perception of Pain During Multi-channel Urodynamics Procedure

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02344745
Enrollment
80
Registered
2015-01-26
Start date
2014-10-31
Completion date
2015-08-31
Last updated
2016-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Pain

Keywords

Lavender, Aromatherapy, Urodynamics

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.

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.

Interventions

OTHERLavandula 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.

OTHERDistilled 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.

Sponsors

University of Southern California
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Anxiety Measured by VASAt the time of catheter placementAnxiety 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

MeasureTime frameDescription
Wong Baker Pain ScaleAt the time of catheter placementPain was measured on the Wong Baker scale from 0-10. Higher values indicate more pain.
Anxiety Measured by VAS15 min after removal of the urodynamics cathetersAnxiety 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
38
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.
40
Total78

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyData collection sheets were lost20

Baseline characteristics

CharacteristicControlLavenderTotal
Age, Continuous48.0 years
STANDARD_DEVIATION 7.5
49.0 years
STANDARD_DEVIATION 8
48.5 years
STANDARD_DEVIATION 7.9
Anxiety4 cm5 cm5 cm
Ethnicity (NIH/OMB)
Hispanic or Latino
37 Participants39 Participants76 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
1 Participants1 Participants2 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Gender
Female
38 Participants40 Participants78 Participants
Gender
Male
0 Participants0 Participants0 Participants
Pain0 units on a scale0 units on a scale0 units on a scale

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 400 / 40
serious
Total, serious adverse events
0 / 400 / 40

Outcome results

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.

Time frame: At the time of catheter placement

ArmMeasureValue (MEDIAN)
ControlAnxiety Measured by VAS4 cm
LavenderAnxiety Measured by VAS3 cm
p-value: 0.08Wilcoxon (Mann-Whitney)
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.

Time frame: 15 min after removal of the urodynamics catheters

ArmMeasureValue (MEDIAN)
ControlAnxiety Measured by VAS0.5 cm
LavenderAnxiety Measured by VAS0 cm
p-value: 0.001Wilcoxon (Mann-Whitney)
Secondary

Wong Baker Pain Scale

Pain was measured on the Wong Baker scale from 0-10. Higher values indicate more pain.

Time frame: At the time of catheter placement

ArmMeasureValue (MEDIAN)
ControlWong Baker Pain Scale0 units on a scale
LavenderWong Baker Pain Scale0 units on a scale
p-value: 0.7Wilcoxon (Mann-Whitney)
Secondary

Wong Baker Pain Scale

Pain was measured on the Wong Baker scale from 0-10. Higher values indicate more pain.

Time frame: 15 min after removal of the urodynamics catheters

ArmMeasureValue (MEDIAN)
ControlWong Baker Pain Scale0 units on a scale
LavenderWong Baker Pain Scale0 units on a scale
p-value: 0.5Wilcoxon (Mann-Whitney)

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026