Creating a Czech Version of the Simplified Faces Pain Scale and the Simplified Concrete Ordinal Pain Scale
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- Pain intensity at Time 0 (immediately prior to the painful procedure) using the Simplified Faces Pain Scale (using self-report).
研究概览
简要总结
The aim is to create a Czech version of pain assessment tools in children, the Simplified Faces Pain Scale (S-FPS) and the Simplified Concrete Ordinal Scale (S-COS), including methodology for their use in practice, and to establish their validity and reliability in pre-school children. The S-FPS is composed of three faces representing three different levels of pain, and the S-COS shows three blocks that symbolize three levels of intensity of pain. The instrument translation and linguistic validation process will be based on the International Society for Pharmacoeconomics and Outcomes Research guidelines (Wild et al., 2005). Validity and reliability will be tested by comparing the children´s pain intensity using the S-FPS and S-COS, which will be completed by the children, and the instrument Face, Legs, Activity, Cry, Consolability (FLACC), which will be completed independently by the attending nurse and the researcher. A repeated measures design will be used as all assessments will be performed prior to a painful procedure (peripheral venepuncture) and will be repeated twice after the painful procedure, once immediately after the painful procedure and a second time 5-10 minutes after the painful procedure. A total of 180 children with will be recruited (aged 3-6 years) from whom complete data will be obtained.
详细描述
Introduction:
For a long time, there has been a myth that children do not remember pain that they were subjected to in the past. However, it has been confirmed that children transfer their negative experience of pain to adulthood. As many studies have shown, information about pain can be obtained from patient self-report, physical response and/or behavioral manifestations. Self-report is considered as the gold standard. The major problem is that most preschool-aged children do not have the necessary cognitive development to use the standard scales.
A group of experts in Canada has developed two new pain scales for this particular age, the Simplified Faces Pain Scale (S-FPS) and the Simplified Concrete Ordinal Scale (S-COS). The S-FPS consists of three faces representing three levels of pain intensity, and the S-COS consists of three blocks that symbolize pain intensity, ranging from mild pain (one block) to severe pain (three blocks). Their research was based on the assumption that younger children are able to distinguish only two or three levels of pain intensity.
Aim:
The aim is to create a Czech version of pain assessment tools in children, the Simplified Faces Pain Scale (S-FPS) and the Simplified Concrete Ordinal Scale (S-COS), including methodology for their use in practice, and to establish their validity and reliability in pre-school children.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Czech-speaking
- •male or female
- •aged 3-6 years
- •scheduled to undergo peripheral venepuncture
- •ability to distinguish three sizes using a toy: small/medium sized/large
- •signed informed consent by parent/significant other
排除标准
- •non-Czech speaking
- •refusal to cooperate by the child,
- •low cognitive ability (inability to distinguish three sizes using a toy: small/medium sized/large)
- •refusal to cooperate by the parent/significant other
结局指标
主要结局
Pain intensity at Time 0 (immediately prior to the painful procedure) using the Simplified Faces Pain Scale (using self-report).
时间窗: Time 0 (immediately prior to the painful procedure)
The Simplified Faces Pain Scale is a self-report measure of pain intensity consisting of pictures of three faces printed on a form, each face represents a different level of pain. Beginning from the left, the first face = mild pain, the middle face = moderate pain, the last face = severe pain.
Pain intensity at Time 2 (5-10 minutes after the painful procedure) using the Simplified Faces Pain Scale (using self-report).
时间窗: Time 2 (immediately after the painful procedure)
The Simplified Faces Pain Scale is a self-report measure of pain intensity consisting of pictures of three faces printed on a form, each face represents a different level of pain. Beginning from the left, the first face = mild pain, the middle face = moderate pain, the last face = severe pain.
Pain intensity at Time 2 (5-10 minutes after to the painful procedure) using the The Face, Legs, Activity, Cry, Consolability instrument (using proxy report by the attending nurse).
时间窗: Time 2 (5-10 minutes after the painful procedure)
The Face, Legs, Activity, Cry, Consolability scale is an observational (behavioral) instrument used to assess pain using 5 criteria: the face, legs, activity, cry, and consolability, which are each assigned a score of 0, 1, or 2. Total score ranges from 0-10 with 0 representing no pain.
Pain intensity at Time 0 (immediately prior to the painful procedure) using the Simplified Concrete Ordinal Scale (using self-report).
时间窗: Time 0 (immediately prior to the painful procedure)
The Simplified Concrete Ordinal Scale is a self-report measure of pain intensity consisting of three blocks that symbolize pain intensity, ranging from mild pain (one block) to severe pain (three blocks).
Pain intensity at Time 0 (immediately prior to the painful procedure) using the The Face, Legs, Activity, Cry, Consolability instrument (using proxy report by the researcher).
时间窗: Time 0 (immediately prior to the painful procedure)
The Face, Legs, Activity, Cry, Consolability scale is an observational (behavioral) instrument used to assess pain using 5 criteria: the face, legs, activity, cry, and consolability, which are each assigned a score of 0, 1, or 2. Total score ranges from 0-10 with 10 representing the most severe pain possible.
Pain intensity at Time 0 (immediately prior to the painful procedure) using the The Face, Legs, Activity, Cry, Consolability instrument (using proxy report by the attending nurse).
时间窗: Time 0 (immediately prior to the painful procedure)
The Face, Legs, Activity, Cry, Consolability scale is an observational (behavioral) instrument used to assess pain using 5 criteria: the face, legs, activity, cry, and consolability, which are each assigned a score of 0, 1, or 2. Total score ranges from 0-10 with 10 representing the most severe pain possible.
Pain intensity at Time 1 (immediately after the painful procedure) using the Simplified Concrete Ordinal Scale (using self-report).
时间窗: Time 1 (immediately after the painful procedure)
The Simplified Concrete Ordinal Scale is a self-report measure of pain intensity consisting of three blocks that symbolize pain intensity, ranging from mild pain (one block) to severe pain (three blocks).
Pain intensity at Time 1 (immediately after to the painful procedure) using the The Face, Legs, Activity, Cry, Consolability instrument (using proxy report by the attending nurse).
时间窗: Time 1 (immediately after the painful procedure)
The Face, Legs, Activity, Cry, Consolability scale is an observational (behavioral) instrument used to assess pain using 5 criteria: the face, legs, activity, cry, and consolability, which are each assigned a score of 0, 1, or 2. Total score ranges from 0-10 with 10 representing the most severe pain possible.
Pain intensity at Time 1 (immediately after the painful procedure) using the Simplified Faces Pain Scale (using self-report).
时间窗: Time 1 (immediately after the painful procedure)
The Simplified Faces Pain Scale is a self-report measure of pain intensity consisting of pictures of three faces printed on a form, each face represents a different level of pain. Beginning from the left, the first face = mild pain, the middle face = moderate pain, the last face = severe pain.
Pain intensity at Time 1 (immediately after to the painful procedure) using the The Face, Legs, Activity, Cry, Consolability instrument (using proxy report by the researcher).
时间窗: Time 1 (immediately after the painful procedure)
The Face, Legs, Activity, Cry, Consolability scale is an observational (behavioral) instrument used to assess pain using 5 criteria: the face, legs, activity, cry, and consolability, which are each assigned a score of 0, 1, or 2. Total score ranges from 0-10 with 10 representing the most severe pain possible.
Pain intensity at Time 2 (5-10 minutes after the painful procedure) using the Simplified Concrete Ordinal Scale (using self-report).
时间窗: Time 2 (5-10 minutes after the painful procedure)
The Simplified Concrete Ordinal Scale is a self-report measure of pain intensity consisting of three blocks that symbolize pain intensity, ranging from mild pain (one block) to severe pain (three blocks).
Pain intensity at Time 2 (5-10 minutes after to the painful procedure) using the The Face, Legs, Activity, Cry, Consolability instrument (using proxy report by the researcher).
时间窗: Time 2 (5-10 minutes after the painful procedure)
The Face, Legs, Activity, Cry, Consolability scale is an observational (behavioral) instrument used to assess pain using 5 criteria: the face, legs, activity, cry, and consolability, which are each assigned a score of 0, 1, or 2. Total score ranges from 0-10 with 0 representing no pain.
次要结局
未报告次要终点
研究者
Petra Kasparova
Principal Investigator
Palacky University