Lavender Aromatherapy for Anxiety During Urodynamics
Ключови думи
Резюме
Описание
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.
Дати
| Последна проверка: | 09/30/2016 |
| Първо изпратено: | 01/06/2015 |
| Очаквано записване подадено: | 01/15/2015 |
| Първо публикувано: | 01/25/2015 |
| Изпратена последна актуализация: | 10/23/2016 |
| Последна актуализация публикувана: | 12/15/2016 |
| Дата на първите подадени резултати: | 05/31/2016 |
| Дата на първите подадени резултати от QC: | 10/23/2016 |
| Дата на първите публикувани резултати: | 12/15/2016 |
| Действителна начална дата на проучването: | 09/30/2014 |
| Приблизителна дата на първично завършване: | 07/31/2015 |
| Очаквана дата на завършване на проучването: | 07/31/2015 |
Състояние или заболяване
Интервенция / лечение
Other: Lavender
Other: Control
Фаза
Групи за ръце
| Arm | Интервенция / лечение |
|---|---|
| Placebo Comparator: Control Distilled water | Other: Control 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. |
| Experimental: Lavender Lavandula angustifolia essential oil (Aura Cacia) | Other: Lavender 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. |
Критерии за допустимост
| Възрасти, отговарящи на условията за проучване | 18 Years Да се 18 Years |
| Полове, допустими за проучване | Female |
| Приема здрави доброволци | Да |
| Критерии | 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 |
Резултат
Първични изходни мерки
1. Anxiety Measured by VAS [At the time of catheter placement]
Вторични изходни мерки
1. Wong Baker Pain Scale [At the time of catheter placement]
2. Anxiety Measured by VAS [15 min after removal of the urodynamics catheters]
3. Wong Baker Pain Scale [15 min after removal of the urodynamics catheters]
