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临床试验/NCT01181687
NCT01181687已完成不适用

Psychometric Testing of the Norwegian Version of the Comfort Behavioral Scale

Sykehuset Telemark1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2011年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
Increase in Comfort behavioral scale score

研究概览

简要总结

The purpose of this study is to establish reliability and validity of the Norwegian version of the Comfort behavioral scale.

详细描述

Structured pain assessment is the foundation for the management of pain. Several different pain measurement tools exists, among them the Comfort behavioral scale (van Dijk, 2005), developed from the original Comfort scale (Ambuel, 1992). The psychometric properties of the Comfort scale have been tested in several studies, but so far no Norwegian version of the scale has been developed and tested. Neither has the scale been tested in spontaneously breathing children undergoing minor surgery. The aim of this study is to establish incipient psychometric properties of the Norwegian version of the scale among children aged 0-3 years admitted for elective minor surgery.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
40 Weeks 至 3 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Younger than 3 years old at the time of surgery
  • Day care patients admitted for minor elective surgery

排除标准

  • Pre-entry use of sedation and/or analgesics
  • Neurological or other diseases or drugs (neuromuscular blockers) thet significantly influence motor activity, facial expression, cognition, or emotional state, ex. cerebral palsy, myopathy, severe mental retardation, severe hypotonia, neuromuscular disease

结局指标

主要结局

Increase in Comfort behavioral scale score

时间窗: Within 24 hours after admission to the hospital for surgery

Testing the hypothesis that there will be a clincal significant increase in Comfort-score when the scores from admission and after surgery are compared. The highest registered score obtained during the first 24 hours after surgery will be used for this analysis. We assume that the score at admission reflects no pain/sedation, while the scores after surgery reflect varying degree of pain

次要结局

  • Convergent validity of the Comfort behavioral scale(Within 24 hours after admission to the hospital for surgery)
  • Inter-rater reliability of the Comfort behavioral scale(Within 24 hours after admission to the hospital for surgery)
  • Reduction in Comfort behavioral scale score (2)(Within 24 hours after admission to the hospital for surgery)
  • Reduction in Comfort behavioral scale score (1)(Within 24 hours after admission to the hospital for surgery)

研究者

发起方
Sykehuset Telemark
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Geir Hoff

Professor

Sykehuset Telemark

研究点 (1)

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