Assessing the Effects of Educational Training Aimed to Improve Pain-reporting Reliability in Children After Surgery
Treating pain, just as treating other medical conditions, depends on accurate assessment of patient's condition. When assessing pain, as other subjective symptoms, the challenge is twofold because the assessment is dependent on patient's understanding and use of the scale, all the more so in children
So far, attempts to improve pain assessments have been focused on the development and refining pain scales. No emphasis has been placed on improving patient's ability to report their pain. Our purpose is to evaluate a training program designed to improve the quality of children's post-surgical pain intensity reports.
After receiving Helsinki approval, eligible children and their parents will signed informed-consent. After surgery, the children, their parents, and the department nurses will assess children's pain intensity. Immediately after the nurse assessment, parents will assess their child's pain (blindly and independently) and the children will report their pain on four different pain scales.
Children aged 8-17, hospitalized in Rambam medical-center for elective surgery will be invited to participate. Children in the experimental group will be exposed to a training program, developed for this study, aimed to teach and train how to report pain. The control group will receive the standard pre-surgical instructions.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Haifa、以色列、3498838
- University of Haifa, The Clinical Pain Innovation Lab
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- children at age 8-17 years;
- absence of psychiatry, cognitive, and/or neurological disorders;
- understand the purpose and the instructions of the study, agree to participate and parent signed inform consent.
Exclusion Criteria:
1. children suffering from Post traumatic stress disorder.
学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Interventional arm
The intervention, which was aimed to educate children on how to use pain scales and provide reliable pain assessments was based on a two short animation clips, lasting approximately 5 min each, and a short (5 min) guided interaction between the study nurse and the participants, in between the two clips.
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The first animation clip focuses on the importance of pain assessment introduce three pain scales (categorical, NPS and faces) followed by explanations on their properties and on the appropriate way to use them.The second movie was aimed to provide an opportunity to implement the new knowledge in case studies
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其他：Control
Children underwent the routine pre-operative preparations, which included a section on pain assessment.
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Routine preoperative preparations, which included a section on pain assessment instructions.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Quality of pain intensity scores based on the concordance between pain reports on different scales.
大体时间：Pain intensity rating before analgesic consumption.
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The average difference between scores reported on the different scales was calculated as follows: The difference between to pain scores reported on each possible pairs of two scales was calculated in absolute values.
The average difference of the 6 pairs was calculated.
The 5-point CAT was transformed into a 0-10 scale by multiplying its values by 2.5.
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Pain intensity rating before analgesic consumption.
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Quality of pain intensity scores based on the concordance between pain reports on different scales.
大体时间：Pain intensity rating one hour after analgesic consumption.
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The average difference between scores reported on the different scales was calculated as follows: The difference between to pain scores reported on each possible pairs of two scales was calculated in absolute values.
The average difference of the 6 pairs was calculated.
The 5-point CAT was transformed into a 0-10 scale by multiplying its values by 2.5.
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Pain intensity rating one hour after analgesic consumption.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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The difference between children assessment vs. nurses assessment.
大体时间：NPS ratings before and one hour after analgesic consumption
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The difference between children pain assessment vs. nurses assessment on a 0-10 numerical pain scale (NPS), in which 0 indicates "no pain" and 10 "the worst pain imaginable."
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NPS ratings before and one hour after analgesic consumption
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The average difference between children assessment vs. parents.
大体时间：NPS ratings before and one hour after analgesic consumption
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The difference between children pain assessment vs. parents assessment on a 0-10 numerical pain scale (NPS), in which 0 indicates "no pain" and 10 "the worst pain imaginable."
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NPS ratings before and one hour after analgesic consumption
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The average decrease in pain following analgesia: NPS
大体时间：NPS ratings before and one hour after analgesic consumption
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The average decrease in pain following analgesic consumption (Delta NPS) based on a 0-10 numerical pain scale (NPS), in which 0 indicates "no pain" and 10 "the worst pain imaginable."
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NPS ratings before and one hour after analgesic consumption
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Quality of pain intensity scores based on the concordance between pain reports on different scales.
大体时间：Pain intensity ratings before analgesic consumption.
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The within-subjects standard deviation (SD) between the 4 pain scores (provided at the same time of assessment).
To assure that variability will be appropriately reflected by this measure, subjects who reported only "0" or only "10" in all 4 scales were excluded from this analysis due to potential bias of the within-subjects SD due to floor or ceiling effects.
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Pain intensity ratings before analgesic consumption.
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Quality of pain intensity scores based on the concordance between pain reports on different scales.
大体时间：Pain intensity ratings one hour after analgesic consumption.
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The within-subjects standard deviation (SD) between the 4 pain scores (provided at the same time of assessment).
To assure that variability will be appropriately reflected by this measure, subjects who reported only "0" or only "10" in all 4 scales were excluded from this analysis due to potential bias of the within-subjects SD due to floor or ceiling effects.
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Pain intensity ratings one hour after analgesic consumption.
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 0091-19-RMB
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
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