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临床试验/NCT01976403
NCT01976403已完成不适用

AA Randomized Controlled Trial to Evaluate the Effect of an Intervention to Enhance Patients' Pain Management After Discharge From Cardiac Surgery

Oslo Metropolitan University1 个研究点 分布在 1 个国家目标入组 416 人开始时间: 2012年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
416
试验地点
1
主要终点
Pain intensity

研究概览

简要总结

The main objective of this randomized controlled trial is to evaluate the effect of an intervention formed as a pain booklet provided to patients at discharge from hospital following cardiac surgery.

The primary objectives are to:

  1. Develop and implement a pain booklet to improve pain management after cardiac surgery
  2. Evaluate the effect of the pain booklet compared to a group of patients given usual care

研究设计

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

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

  • undergoing their first elective CABG, valve surgery or a combination
  • receiving the standard preadmission information
  • able to take care of themselves after discharge
  • able to read and write Norwegian and fill in the questionnaires
  • able to be contacted by telephone

排除标准

  • more than 12 hours at the intensive care unit after surgery

结局指标

主要结局

Pain intensity

时间窗: Baseline, day 1, day 2, day 3, day 4, day 7, day 30, day 90, day 180, day 360

Change from Baseline in pain intensity at day 1, day 2, day 3, day 4, day 7,day 30, day 90, day 180 and day 360

pain-related interference

时间窗: Baseline, day 7, day 30, day 90, day 180, day 360

Change from Baseline in pain-related interference at day 1, day 2, day 3, day 4, day 7,day 30, day 90, day 180 and day 360

次要结局

  • analgesic intake(baseline, day 1, day 2, day 3, day 4, day 7, day 30, day 90, day 180, day 360)
  • Quality of life(baseline, day 7, day 90, day 180, day 360)

研究者

发起方
Oslo Metropolitan University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marit Leegaard

Associate Professor

Oslo Metropolitan University

研究点 (1)

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