Auriculotherapy - Pain Management of Aspiration Abortion
关键词
抽象
描述
Most first trimester aspiration abortions are performed in the outpatient setting with a paracervical block and nonsteroidal anti-inflammatory drugs (NSAIDs) as the only analgesics. Yet first trimester aspiration pain control is often inadequate with 26-32% of women reporting that they experienced severe pain. Moderate sedation and general anesthesia are not readily available, and investigations on opioids and anxiolytics have consistently found them ineffective for first trimester aspiration abortion pain. In 2018, The National Academies of Sciences, Engineering, and Medicine (NASEM) recommended research to improve pain relief. Limited data indicate that acupuncture is valuable in dysmenorrhea and for labor pain, conditions in which pain may be similar to that experienced during aspiration abortion.
This randomized trial will recruit women seeking first trimester aspiration abortion. This study will evaluate two types of auriculotherapy applied to selected acupoints on the external ear. The study treatments are acupressure using gold beads and acupuncture using Pyonex needles; both are applied to the ear using adhesive disks. A control group will receive the adhesive disks alone. All participants will receive usual care for their aspiration abortion procedure, including a paracervical block and ibuprofen for pain management. The investigators will query the participants regarding pain and anxiety immediately after their procedure, in person, on the day of their procedure.
日期
| 最后验证: | 01/31/2020 |
| 首次提交: | 03/26/2019 |
| 提交的预估入学人数: | 03/27/2019 |
| 首次发布: | 03/28/2019 |
| 上次提交的更新: | 02/04/2020 |
| 最近更新发布: | 02/06/2020 |
| 实际学习开始日期: | 03/27/2019 |
| 预计主要完成日期: | 12/11/2019 |
| 预计完成日期: | 12/11/2019 |
状况或疾病
干预/治疗
Device: Auriculotherapy - Acupressure with Gold Beads
Device: Auriculotherapy - Acupuncture with Pyonex Needles
Device: Placebo Group
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Active Comparator: Auriculotherapy - Acupressure with Gold Beads A designated trained auriculotherapy provider will place gold beads at five acupoints on each ear (10 points total). The beads are affixed with a small round adhesive disk. The beads will stay in place during the aspiration abortion and will be removed before the participant is discharged home. | Device: Auriculotherapy - Acupressure with Gold Beads Single-use gold-plated 1.2mm beads/balls attach to pre-specified acupoints on the participant's ears with adhesive disk/tape. |
| Active Comparator: Auriculotherapy - Acupuncture with Pyonex Needles A designated trained auriculotherapy provider will place 1.2mm (Pyonex) needles at five acupoints on each ear (10 points total). The needles are affixed with a small round adhesive disk. The needles will stay in place during the aspiration abortion and will be removed before the participant is discharged home. | Device: Auriculotherapy - Acupuncture with Pyonex Needles Single-use 1.2mm acupuncture press needles attach to pre-specified acupoints on the participant's ears with adhesive disk/tape. |
| Sham Comparator: Placebo Group A designated trained auriculotherapy provider will place adhesive disks at five acupoints on each ear (10 points total). The disks resemble those used with the active treatments. The disks will stay in place during the aspiration abortion and will be removed before the participant is discharged home. | Device: Placebo Group Single-use adhesive disks without needles or beads. |
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 | bullets Inclusion Criteria: - Pregnant up to 13 weeks gestation - Seeking aspiration abortion for any first trimester induced abortion, abnormal pregnancy, early pregnancy loss, retained products of conception, or molar pregnancy - English- or Spanish-speaking - Willingness to be randomized into one of the three arms. Exclusion Criteria: - Allergy to adhesives or gold - Allergy or intolerance to ibuprofen or 1% lidocaine (paracervical block) - Congenital anomaly or infection of the ear. |
结果
主要结果指标
1. Pain visual analog scale score (beads vs placebo) [Immediately following the aspiration abortion procedure (approximately 10 minutes)]
次要成果指标
1. Pain visual analog scale score (needles vs placebo) [Immediately following the aspiration abortion procedure (approximately 10 minutes)]
其他成果措施
1. Anxiety visual analog scale score [Immediately following the aspiration abortion procedure (approximately 10 minutes)]
