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临床试验/NCT06390007
NCT06390007已完成不适用

The Efficacy of Acupuncture in the Management of Postoperative Pain in the Pediatric Intensive Care Unit at Cipto Mangunkusumo Hospital

Indonesia University2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年9月12日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
2
主要终点
Face, Legs, Activity, Cry, and Consolability (FLACC) pain scale

研究概览

简要总结

Pain is an unpleasant sensory and emotional experience resulting from tissue damage. Pain management is typically conducted according to the World Health Organization (WHO) pain management ladder. Analgesics administered to pediatric patients vary in dosage and type, but these analgesics often have significant side effects. The acupuncture technique using press needles is a non-pharmacological pain therapy modality that has been studied for its ability to reduce the use of analgesic drugs, thereby potentially decreasing side effects associated with analgesic use.

The study was conducted using a randomized controlled trial (RCT) design involving 70 pediatric postoperative patients aged 1-18 years who were admitted to the Pediatric Intensive Care Unit at Cipto Mangunkusumo Hospital. Subjects were divided into two groups: a control group and an experimental group. The control group received standard analgesic therapy and sham press needle application (a patch resembling a press needle without a needle), while the experimental group received standard analgesic therapy and press needle application at acupuncture points after the patient had been in the Pediatric Intensive Care Unit for 24 hours. Pain scale monitoring was conducted at 1, 6, 24, 48, and 72 hours using the Face, Legs, Activity, Cry, and Consolability (FLACC) scale for children aged 1-8 years, and the Numeric Rating Scale (NRS) for children over 8 years old.

This study hypothesizes that the acupuncture technique using press needles can reduce the pain scale in pediatric postoperative patients, leading to a decrease in the use of analgesics and a reduction in side effects associated with analgesic use.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
1 Year 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Pediatric postoperative patients admitted to the Pediatric Intensive Care Unit at Cipto Mangunkusumo Hospital
  • Aged between 1 and 18 years
  • Patients with a platelet count greater than 20,000/mL
  • Patients undergoing elective surgery
  • Willingness to participate in the study

排除标准

  • Patients with a local infection at the puncture site
  • Patients with anatomical abnormalities of the outer ear
  • Failure to complete the acupuncture therapy
  • Patients with chronic illnesses who have previously received analgesic therapy

结局指标

主要结局

Face, Legs, Activity, Cry, and Consolability (FLACC) pain scale

时间窗: Pain scale monitoring will be conducted at 1 hour; 6 hours; 24 hours; 48 hours; and 72 hours after the application of sham press needle / press needle acupuncture

The Face, Legs, Activity, Cry, and Consolability (FLACC) pain scale for children aged 1 to 8 years is used to assess pain levels

Numeric Rating Scale (NRS) pain scale

时间窗: Pain scale monitoring will be conducted at 1 hour; 6 hours; 24 hours; 48 hours; and 72 hours after the application of sham press needle / press needle acupuncture

The Numeric Rating Scale (NRS) is used to assess pain levels in children over the age of 8.

Behavioral Pain Scale (BPS)

时间窗: Pain scale monitoring will be conducted at 1 hour; 6 hours; 24 hours; 48 hours; and 72 hours after the application of sham press needle / press needle acupuncture

The Behavioral Pain Scale (BPS) with a range of 3 to 12 for patients on ventilators.

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

Dr. dr. Irene Yuniar, Sp.A(K)

Lecturer of Indonesia University

Indonesia University

研究点 (2)

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