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临床试验/NCT02252003
NCT02252003已完成不适用

Development of a New Pain Rating Scale for Children and Validation Against Criteria by Comparison With Faces Pain Scale - Revised (FPS-R) and Visual Analogue Scale (VAS)

Hospices Civils de Lyon2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2015年5月21日最近更新:
适应症
干预措施

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
Pain assessment (4-11 years old)

研究概览

简要总结

In clinical practice with young children, gold standard rating scales used to evaluate the pain are VAS (Visual Analogue Scale) and FPS-R (Faces Pain Scale - Revised), which are self-assessment tools. These scales present however certain limitations: the VAS is not applicable if the child does not know how to estimate the distances, as young children, or children with mental retardation. As for FPS-R, it can be frightening for children by the aspect of faces looking like impersonal masks.

For children under 4 years, only hetero-evaluation based on typical behavioral scales as Face Legs Activity Cry Consolability (FLACC) can be used, according to the current recommendations.

We thus wanted to create a new faces scale with teddy bear faces, which are cross-cultural and timeless. Our objective is to validate the new teddy scale in its paper shape on a wide sample of children. We made the hypothesis that the teddy scale would enable to evaluate the pain in the same way that the FPS-R, being better accepted and preferred by children.

The first phase of this study will be to develop the teddy scale with a sample of 30 healthy children from 4 to 11 year-old, having already experienced pain. This stage allows the validation of the images chosen for the scale, to make sure of their relevance and their optimal recognition by the children.

The scale will then be validated with a sample of 218 hospitalized children from 2 to 11 years old, to whom pain is usually evaluated in a systematic way. Children from 4 to 11 years old will have simultaneously the teddy scale, the VAS and the FPS-R. They will be asked to determine which scale they preferred. Children from 2 to 4 years old will have the teddy scale; the FLACC will be filled in by parents.

Tested hypothesis: The discriminating characteristic of the teddy scale is superior to that of the FPS-R scale The validation of the teddy scale will enable to objectify children's pain, to facilitate the decision-making in the choice of the analgesic to prescribe, and to check the efficiency of these decisions. This teddy scale could be used in current practice as a replacement of the FPS-R.

Following this study, we planned to set up a second project in which the teddy scale will be adapted to electronic form (touchpads), to test its adaptability with the children.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
2 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Affiliated with the French healthcare system
  • Agreed to participate in the study, of which parents/ holders of parental authority signed the informed consent form
  • Scale development phase:
  • Children aged from 4 to 11 years at inclusion
  • Having already experienced pain
  • Scale validation phase:
  • Children aged from 2 to 11 years old at inclusion
  • Hospitalized in one of the Hôpital Femme-Mère-Enfant (HFME) departments
  • At risk of presenting pain, that is to whom the pain is usually evaluated in a systematic way

排除标准

  • Children among whom the understanding and/or the language is not sufficient to allow a good comprehension of study instructions
  • Children participating simultaneously in another interventional research, being able to interfere with the study results

研究组 & 干预措施

Pain scales testing

Experimental

干预措施: Pain scales testing (Other)

结局指标

主要结局

Pain assessment (4-11 years old)

时间窗: Baseline

Children aged 4-11 will be asked to score the pain they feel at that time, using the 3 scales presented in a randomly assigned order. The measure of the correlation between the scores of the 3 pain scales: VAS score (continuing : 0.0 to 10.0), FPS-R score (0,2,4,6,8,10), and teddy scale score (0,2,4,6,8,10) will be evaluated.

次要结局

  • Pain assessment (2-3 years-old)(Baseline)
  • Sensibility of change of teddy and FPS-R scales(Baseline)
  • Pain assessment (4-11 years old) depending on age.(Baseline)
  • Scale preference (4-11 years old)(Baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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