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临床试验/NCT03784469
NCT03784469已完成不适用

Effectiveness of Positioning on Back Pain After Transcatheter Arterial Chemoembolization Among Patients With Hepatocellular Carcinoma

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2018年2月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
The overall trend of back pain

研究概览

简要总结

Changing patients' position in the bed after TACE can decrease the level of back pain without increasing the amount of bleeding and hematoma,bring patients some comfort and relieving abdominal bloating, increase patients' satisfaction.

详细描述

Background:During the treatment for the liver cancer patients who are treated by Transcatheter Arterial Chemoembolization (TACE), the embolic agent with chemotherapeutic drugs are injected through a catheter into a femoral artery directly supplying the tumor. Hence, after the procedure, to avoid bleeding and hematoma at the puncture site, the puncture site at groin needs to be pressed by sandbag and the affected limb needs to remain straight. These patients have to lay down on beds and are not allowed to move for at least 4 hours. Due to pressure exerted continuously to the same muscles, may cause back muscle rigidity and spasms, these patients may suffer from back pain and discomfort. In addition to usual pharmacological treatment, nursing intervention aimed at decreasing patient discomfort, therefore, this study will refer to the previous researches to develop the methods and procedures of changing body positions and apply these methods to the liver cancer patients who are treated by TACE.

Purpose:The aim of this study was to compare the level of back pain and on the amount of bleeding and hematoma between those patients changing body positions in bed and those patients not changing body positions after TACE.

Methods: This study was a randomized clinical trial. The sample consisted of 78 patients who had undergone TACE via the femoral artery, patients by using a convenience sampling assigned to either the control or experimental group (each group consisting 39 participants). All patients need to be pressed on the puncture site at groin with a sand bag of 2.5 kg for 2 hours and lie down for 4 hours. The control group received the usual care, remaining supine position in complete bed rest and immobilized. Experimental group patients received position changes in the second hour and the fourth hour after TACE.

Results: The overall trend of back pain is different between the two groups ( p <.001) , the mean of pain intensity in the second ( p =.006) and the forth hour ( p <.001) showed a significant difference. Experimental group patients had significantly less back pain than the control group after TACE . For the within subjects factor of time, the levels of back pain differed significantly across the five-time periods in experimental group ( p < .05) . In the aspect of post embolization syndrome , control group patients had significantly abdominal bloating than the experimental group ( p =.003) . None of patients developed hematoma, there was no significant difference between the two groups in terms of amount of bleeding. On the whole, experimental group patients had significantly higher satisfaction than the control group ( p =.018).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient with hepatocellular carcinoma hospitalized for TACE .
  • Consciousness can be communicated in Mandarin and Taiwanese.

排除标准

  • Symptoms of back pain before TACE.
  • Under the treatment of analagesics within 24 hours before TACE.
  • Anticoagulant was not discontinued for at least 7 days before TACE.
  • Inguinal hemorrhage or hematoma during the TACE or before removal of the vascular sheath.
  • Hemological diseases that are prone to bleeding, i.e. hemophilia and leukemia.
  • Platelet count lower than 70K or INR (international normalized ratio) is greater than 1.
  • No hemostatic cotton use.
  • Can not change the position in bed after TACE.

结局指标

主要结局

The overall trend of back pain

时间窗: Within 4 hours after TACE

The patients were asked to describe their back pain and rate its severity by using the Numerical Rating Scale (NRS-11).To determine if there is any significant difference the two groups. The NRS-11 with scores of 0 and 10 indicating no pain and excruciating pain, respectively.

次要结局

  • The mean of back pain in the control group(Within 4 hours after TACE)
  • Post embolization syndrome(Within 4 hours after TACE.)
  • The mean of back pain between two groups(Within 4 hours after TACE)
  • Patients' satisfaction(Patient's satisfaction will be evaluated at the 4th hour.)
  • The mean of back pain in the experimental group(Within 4 hours after TACE)
  • Vascular complication(Femoral puncture sites were assessed every hourly for the following 4 hours by researcher and a nurse.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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