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临床试验/NCT04917614
NCT04917614已完成不适用

Effect of Transcutaneous Electrical Acupoint Stimulation on Obstetric Quality of Recovery-10 After Cesarean Section

Konya Meram State Hospital1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2021年7月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
86
试验地点
1
主要终点
Quality of Recovery

研究概览

简要总结

The primary aim of this prospective and randomized trial is to investigate the effect of TEAS on postoperative recovery using the Obstetric Quality of Recovery-10 questionnaire in patients undergoing elective cesarean section.

详细描述

Acupoint stimulation is postulated to modulate neurological signal transmission through afferent nociceptive pathways. Acupoint stimulation has been associated with positive effects on perioperative symptoms such as nausea, pain, and sleep disturbance. Transcutaneous electrical acupuncture point stimulation (TEAS) is an acupuncture treatment developed by combining traditional Chinese acupuncture with transcutaneous electrical nerve stimulation. TEAS has proven to be effective in postoperative pain and nausea-vomiting by applying a current of different frequencies, intensities, and waveforms through electrodes adhering to the skin. Using TEAS may relieve perioperative symptoms without increasing the risk of drug-related adverse events and alleviate and improve the patient's health condition, including the postoperative perspective.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 48 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Elective cesarean operation
  • •Able to give informed consent

排除标准

  • •Patients with neurological or psychological diseases
  • •patients with chronic analgesic and antidepressant drug use
  • •Patients unable to communicate
  • •Patients previously treated with TEAS or acupuncture,
  • •Patients with heart failure and have pace-maker,
  • •patient with local infection in the TEAS area

研究组 & 干预措施

group teas

Active Comparator

Patients in the TEAS group will receive preoperative TEAS for 30 min before the spinal anesthesia at Hegu (LI4), Neiguan (PC6), and Zusanli (St 36) with an electronic acupuncture device.

干预措施: Transcutaneous Electrical Acupoint Stimulation (Device)

Control Group

Sham Comparator

In the sham group, the patients were connected to the electronic acupuncture, but electronic stimulation was not applied.

干预措施: Transcutaneous Electrical Acupoint Stimulation (Device)

结局指标

主要结局

Quality of Recovery

时间窗: The first 24 hours postoperatively

Obstetric Quality of Recovery-10 (ObsQoR-10©) Scoring Tool

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Betul Kozanhan

Ass.Prof.

Konya Meram State Hospital

研究点 (1)

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