Lavender Aromatherapy for Anxiety During Urodynamics
关键词
抽象
描述
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.
日期
| 最后验证: | 09/30/2016 |
| 首次提交: | 01/06/2015 |
| 提交的预估入学人数: | 01/15/2015 |
| 首次发布: | 01/25/2015 |
| 上次提交的更新: | 10/23/2016 |
| 最近更新发布: | 12/15/2016 |
| 首次提交结果的日期: | 05/31/2016 |
| 首次提交质量检查结果的日期: | 10/23/2016 |
| 首次发布结果的日期: | 12/15/2016 |
| 实际学习开始日期: | 09/30/2014 |
| 预计主要完成日期: | 07/31/2015 |
| 预计完成日期: | 07/31/2015 |
状况或疾病
干预/治疗
Other: Lavender
Other: Control
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| 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. |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | Female |
| 接受健康志愿者 | 是 |
| 标准 | 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 |
结果
主要结果指标
1. Anxiety Measured by VAS [At the time of catheter placement]
次要成果指标
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]
