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临床试验/NCT03205579
NCT03205579已完成不适用

Effectiveness of Pain Education to Improve Cancer Pain Management in Hospitalized Patients

Mahidol University4 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2018年9月20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
48
试验地点
4
主要终点
Pain intensity

研究概览

简要总结

Cancer pain is one of the problems of treating cancer pain. Although, there is a WHO analgesic ladder to improve this problem, it is still inadequate pain control. Pain does not affect only physical but also emotional and quality of life.

From review literatures we found that patients' knowledge about cancer pain management is inaccurate; for example, fear to use opioid, try to patience of pain, concerning only cancer treatments, which can cause of unfavorable pain management outcome.

Therefore, we will conduct the RCT of using pain education by video comparing to conventional face to face pain education by nurse in hospitalized cancer pain patients.We will use 25 MCQs examination for testing pre-post intervention to test level of understanding of patients. The measurements are NRS, ThaiHADs and FACT-G at the first and last day of study. We expect that NRS should improve more than 50% at the seven day of study.

详细描述

protocol Randomized controlled trial study Sample size is 70 patients divided to 2 groups (35 for video group and 35 for conventional face to face group) Inclusion criteria

  1. patients' age 18-70 years old
  2. moderate to severe cancer pain
  3. ECOG(Eastern cooperative Oncology Group) performance status <= 3
  4. Patients can write and read Thai language Exclusion criteria

1.Clinical unstability 2.Confusion and delirium 3.Bed ridden 4.Psychotic problem We will randomly allocate patients by using computer program nQuery advice 6.0. After patients sign inform consent we will record baseline characteristics, assess baseline Numerical rating scale (NRS), emotional status (ThaiHADs), Quality of life status (FACT-G). All patients will do the 25 MCQs test within 30 minutes before intervention. Video group will watch video 10 minutes and conventional group will receive pain education from trained nurse in the same period. The knowledge includes cancer pain definition, cancer pain management, pain assessment and role of patients in cancer pain management. After finishing intervention patients will the same 25 MCQs test (30 minutes) and patients can ask questions to the trained nurse.

All patients will be educated to record pain diary everyday for seven days. All patients will receive standard pain management from the physicians. At the day seven we will assess NRS, ThaiHADs and FACT-G and finish the study.

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 (Care Provider)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • moderate to severe pain (NRS>4) cancer pain
  • ECOG (Eastern cooperative Oncology group) performance status <=3
  • Can read, listen, write Thai language

排除标准

  • Clinical instability
  • Confusion and delirium
  • Bed ridden
  • Psychotic problem

结局指标

主要结局

Pain intensity

时间窗: seven days

The pain reduction will be assessed and compared using numerical rating (NRS) from 0-10; 0 designating "no pain" and 10 designating " worst possible pain" scale between the first day and the seventh day of study

次要结局

  • Emotional status(seven days)
  • Functional assessment(seven days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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