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经皮电刺激联合非药物措施减轻产痛的效果:一项随机对照试验的研究方案。

Effects of the addition of transcutaneous electrical stimulation to non-pharmacological measures in labor pain: study protocol for a randomized controlled trial.

机构信息

Health Sciences Post Graduation Program, Federal University of Uberlândia, Uberlândia, Brazil.

Health Sciences Post Graduation Program, Federal University of Goiás, Goiânia, Brazil.

出版信息

Trials. 2022 Jan 17;23(1):44. doi: 10.1186/s13063-021-05969-0.

Abstract

BACKGROUND

Labor, although natural and physiological, is a period that can be marked by stress, pain, anxiety, suffering, fear, and anguish for a woman. Thus, non-pharmacological methods that reduce pain during labor are important to allow a better experience without the use of medications. Therefore, the aim of this study is to evaluate the effects of non-pharmacological pain relief methods, added or not to the application of transcutaneous electrical stimulation (TENS), on pain, satisfaction with the childbirth, duration of labor, and newborn conditions.

METHODS

This is a randomized controlled clinical trial, with a non-probabilistic convenience sample, composed of women in the first active stage of labor, admitted to a public institution. The parturients will be divided into 3 groups: group 1 (n = 36) composed of parturients who will have continuous support and will be encouraged to walk, adopting different positions with the use of the Swiss ball and receiving back massage for 30 min; group 2 (n = 36) composed of parturients who will also have continuous support and will be encouraged to walk, adopt different positions using the Swiss ball, and will receive the application of TENS for 30 min; and group 3 (n = 36) composed of parturients who will have continuous support and will be encouraged to walk, adopting different positions with the use of the Swiss ball, and will receive placebo TENS application for 30 min. The outcomes evaluated in the study will be pain intensity assessed by the visual analog scale of pain applied before, immediately after, and 30 min and 1 h after the interventions; Experience and Satisfaction with Childbirth Questionnaire (QESP) applied 12 to 24 h after delivery; and data regarding delivery (type of delivery, total duration of labor, and possible obstetric complications) and neonate (weight, height, possible complications, Apgar score in the first and fifth minutes).

DISCUSSION

With this research, it is expected to understand the effects of the intervention through TENS electrostimulation added to other non-pharmacological methods for pain management during labor.

TRIAL REGISTRATION

Brazilian Registry of Clinical Trials (REBEC) RBR-68kh6j . Registered on March 17, 2020.

摘要

背景

分娩虽然是自然且生理的过程,但对女性来说,这也是一个充满压力、疼痛、焦虑、痛苦、恐惧和痛苦的时期。因此,使用非药物方法来减轻分娩时的疼痛对于实现更好的分娩体验非常重要,同时无需使用药物。因此,本研究旨在评估非药物性止痛方法的效果,这些方法单独或联合经皮电刺激(TENS)应用于分娩时对疼痛、对分娩的满意度、分娩持续时间和新生儿状况的影响。

方法

这是一项随机对照临床试验,采用非概率便利样本,由公立机构收治的处于活跃第一产程的产妇组成。产妇将分为 3 组:第 1 组(n=36)由将持续接受支持并被鼓励行走、采用不同姿势并使用瑞士球以及接受 30 分钟背部按摩的产妇组成;第 2 组(n=36)由将持续接受支持并被鼓励行走、采用不同姿势并使用瑞士球以及接受 30 分钟 TENS 治疗的产妇组成;第 3 组(n=36)由将持续接受支持并被鼓励行走、采用不同姿势并使用瑞士球以及接受 30 分钟安慰剂 TENS 治疗的产妇组成。本研究评估的结果将是在干预前、干预后即刻以及干预后 30 分钟和 1 小时时通过视觉模拟评分法评估疼痛强度;分娩后 12 至 24 小时时应用分娩经历和满意度问卷(QESP);以及分娩(分娩类型、总产程和可能的产科并发症)和新生儿(体重、身高、可能的并发症、第 1 分钟和第 5 分钟的阿普加评分)数据。

讨论

通过这项研究,预计通过 TENS 电刺激联合其他非药物性分娩疼痛管理方法来了解干预效果。

试验注册

巴西临床试验注册中心(REBEC)RBR-68kh6j。于 2020 年 3 月 17 日注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2c50/8762972/6c9693da824e/13063_2021_5969_Fig1_HTML.jpg

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