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耳针疗法治疗择期剖宫产产妇术前焦虑的随机安慰剂对照盲法研究。

Auricular Acupuncture for Preoperative Anxiety in Parturient Women with Scheduled Cesarean Section: A Randomized Placebo-Controlled Blind Study.

机构信息

Service d'Anesthésie, Réanimation, Douleur, Hôpital de la Croix Rousse, Hospices Civils de Lyon, Université Claude Bernard Lyon 1, Lyon, France.

Service de Gynécologie-Obstétrique, Hôpital de la Croix Rousse, Hospices Civils de Lyon, Université Claude Bernard Lyon 1, Lyon, France.

出版信息

J Integr Complement Med. 2022 Jul;28(7):569-578. doi: 10.1089/jicm.2021.0346. Epub 2022 Apr 8.

Abstract

Preoperative anxiety before cesarean section is a major issue. Nonpharmacologic anxiety control is believed to be more suitable in pregnant women. Auricular acupuncture (AA) is an inexpensive, easy-to-use, and validated intervention to reduce anxiety in different surgical settings. We evaluated the effect of AA on preoperative cesarean section anxiety. In a prospective, blind, controlled trial, pregnant women with a scheduled cesarean section under spinal anesthesia were randomized to receive AA with needle, AA without needle (sham), or usual care (no intervention). Anxiety level was assessed by using a visual analogue scale for anxiety (VAS-A; 0-minimal anxiety, 100-maximal anxiety) at three time points: inclusion (pre-induction room-T0), when entering the operating room (T1), and before incision (T2). The primary outcome was the VAS-A variation (percentage changes) between T0 and T1 in the AAe group compared with that in the sham AA group. The secondary outcomes were the VAS-A variation between T0 and T1 in the AA group compared with that in the control group, and the variation between T0 and T2 compared between the three groups, the effect of AA on parasympathetic tone, and the incidence of adverse effects. In women immediately before anesthesia for cesarean section, the AA produced a 19% decrease of anxiety, compared with a 21% anxiety increase in sham AA, which is significantly different. The effect of AA was more present in women with low initial anxiety. The proportion of patients reaching clinically significant anxiety reduction (>33% from the initial level) was 2.5 times higher in the AA group ( = 0.02) compared with the sham group. No differences in anxiety variations were found compared with the no-intervention group. No effect of AA was noted on parasympathetic tone. Compared with sham, AA decreased maternal anxiety level when arriving in the operation room and just before the beginning of the cesarean section, with a trend toward improvement compared with usual care.

摘要

剖宫产术前焦虑是一个主要问题。非药物性焦虑控制被认为更适合孕妇。耳针(AA)是一种廉价、易于使用且经过验证的干预措施,可减少不同手术环境下的焦虑。我们评估了 AA 对剖宫产术前焦虑的影响。在一项前瞻性、盲法、对照试验中,接受脊髓麻醉下剖宫产的孕妇被随机分为 AA 加针组、AA 不加针(假)组和常规护理(无干预)组。使用视觉模拟焦虑量表(VAS-A;0 为最小焦虑,100 为最大焦虑)在三个时间点评估焦虑水平:纳入(诱导室前-T0)、进入手术室时(T1)和切口前(T2)。主要结局是 AAe 组 T0 与 T1 之间的 VAS-A 变化(百分比变化)与 shamAA 组相比。次要结局是 AA 组 T0 与 T1 之间的 VAS-A 变化与对照组相比,以及三组之间 T0 与 T2 之间的变化,AA 对副交感神经张力的影响以及不良反应的发生率。在接受剖宫产麻醉前的女性中,AA 可使焦虑程度降低 19%,而 shamAA 则使焦虑程度增加 21%,这具有显著差异。AA 的作用在初始焦虑程度较低的女性中更为明显。AA 组达到临床显著焦虑缓解(与初始水平相比降低>33%)的患者比例是 sham 组的 2.5 倍(=0.02)。与无干预组相比,焦虑变化无差异。未发现 AA 对副交感神经张力有影响。与 sham 相比,AA 可降低产妇在进入手术室和剖宫产开始前的焦虑水平,与常规护理相比,有改善趋势。

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