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经颅电刺激缓解行腰麻-硬膜外联合麻醉剖宫产术女性围产期精神健康障碍:一项初步随机临床试验

Transcranial Electrical Stimulation for Relief of Peripartum Mental Health Disorders in Women Undergoing Cesarean Section With Combined Spinal-Epidural Anesthesia: A Pilot Randomized Clinical Trial.

作者信息

Zhao Qiu, Han Yuan, Hu Xiao-Yi, Zhang Song, Zhang Long, Wang Jun, Zhang Qian-Qian, Tao Ming-Shu, Fang Jia-Xing, Yang Jie, Liu Rong-Guang, Sun Xun, Zhou Jian, Li Xiang, Zhang Hongxing, Liu He, Cao Jun-Li

机构信息

Department of Anesthesiology, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.

Jiangsu Province Key Laboratory of Anesthesiology and NMPA Key Laboratory for Research and Evaluation of Narcotic and Psychotropic Drugs, Xuzhou Medical University, Xuzhou, China.

出版信息

Front Psychiatry. 2022 Apr 4;13:837774. doi: 10.3389/fpsyt.2022.837774. eCollection 2022.

Abstract

OBJECTIVE

This study aimed to explore transcranial electrical stimulation (tES) to relieve peripartum anxiety and depressive symptoms in women undergoing cesarean section with combined spinal-epidural anesthesia.

METHODS

This double-blind, randomized, sham-controlled trial was conducted in the Affiliated Hospital of Xuzhou Medical University from March 2021 and May 2021. One hundred and forty-eight full-term parturients giving birth by elective cesarean section were selected, and 126 were included in the intent-to-treat analysis. Parturients were provided standardized anesthesia and randomized to the active-tES (a-tES) group and sham-tES group. Parturients and outcome assessors were blinded to treatment allocation. The primary outcome was the changes in peripartum mental health disorders, including anxiety, assessed by the Pregnancy-Related Anxiety Questionnaire-Revised 2 (PRAQ-R2). Secondary outcomes included peripartum depressive symptoms, assessed by the Edinburgh Postnatal Depression Scale (EPDS), maternal satisfaction, fatigue level, sleep quality index, and pain score during and after operation. Data were collected before entering the operating room (T0), between post-anesthesia and pre-surgery (T1), before leaving the operating room (T2), and at 24 h post-surgery (T3).

RESULTS

One hundred and twenty-six eligible parturients were enrolled in the two groups: a-tES group (N = 62) and sham-tES group (N = 64). Treatment with tES resulted in significantly lower scores of anxiety compared with sham-tES (T2: < 0.001; T3: = 0.001). Moreover, the a-tES groups showed a significant reduction in depression scores (T2: = 0.003; T3: = 0.032).

CONCLUSION

In this randomized pilot study, tES treatment is efficacious in alleviating peripartum anxiety and depressive symptoms in women undergoing cesarean section and has been demonstrated to be a novel strategy for improving peripartum mental health disorders.

CLINICAL TRIAL REGISTRATION

[www.chictr.org.cn], identifier [ChiCTR2000040963].

摘要

目的

本研究旨在探讨经颅电刺激(tES)对接受腰硬联合麻醉剖宫产的女性围产期焦虑和抑郁症状的缓解作用。

方法

本双盲、随机、假手术对照试验于2021年3月至2021年5月在徐州医科大学附属医院进行。选取148例择期剖宫产的足月产妇,126例纳入意向性分析。产妇接受标准化麻醉,并随机分为经颅电刺激治疗组(a-tES组)和假经颅电刺激组。产妇和结果评估者对治疗分配情况不知情。主要结局是围产期心理健康障碍的变化,包括通过修订版妊娠相关焦虑问卷2(PRAQ-R2)评估的焦虑。次要结局包括通过爱丁堡产后抑郁量表(EPDS)评估的围产期抑郁症状、产妇满意度、疲劳水平、睡眠质量指数以及手术期间和术后的疼痛评分。在进入手术室前(T0)、麻醉后至手术前(T1)、离开手术室前(T2)和术后24小时(T3)收集数据。

结果

两组共纳入126例符合条件的产妇:经颅电刺激治疗组(N = 62)和假经颅电刺激组(N = 64)。与假经颅电刺激相比,经颅电刺激治疗导致焦虑评分显著降低(T2:<0.001;T3:=0.001)。此外,经颅电刺激治疗组的抑郁评分显著降低(T2:=0.003;T3:=0.032)。

结论

在这项随机对照试验中,经颅电刺激治疗在缓解剖宫产女性围产期焦虑和抑郁症状方面有效,并已被证明是改善围产期心理健康障碍的一种新策略。

临床试验注册

[www.chictr.org.cn],标识符[ChiCTR2000040963]。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/63d4/9013841/ee22eeff380f/fpsyt-13-837774-g001.jpg

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