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
|Condition or disease||Intervention/treatment||Phase|
|Anxiety Pain||Other: Lavandula angustifolia essential oil (Aura Cacia) Other: Distilled water||Not Applicable|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Care Provider)|
|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|
Placebo Comparator: Control
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.
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.
- 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.
- 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.
- 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.
- 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.
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
|United States, California|
|Los Angeles Count + USC Medical Center|
|Los Angeles, California, United States, 90033|
|Principal Investigator:||Begum Ozel, M.D.||University of Southern California|