The Impact of a Neutral Formulated and Designed Package Insert on Nocebo-effect. (NEUPANO)
Neutral Formulated and Designed Package Insert or Only Verbal Information Compared to Package Insert According EU-directive: a Pilot Randomised Controlled Trial to Analyse the Influence on the Nocebo Effect and Non-adherence
Background The nocebo effect describes the association between the expectation of negative effects, (e.g. side effects) and the actual occurrence of negative effects. Studies have shown that the nocebo effect can be influenced by (risk) communication. Till today there is no study that compares different types of information on adverse events regarding the strength of the nocebo effect.
Aim The aim of this pilot randomized controlled trial is to analyse the influence of different communication types on the frequency and intensity of adverse events and adherence. To increase the relevance and applicability of the results the study intervention builds up on package inserts because these are the most widespread form of information on side effects.
Methods Patients It is planned to include 60 patients in the study.
Intervention
- Modified package insert: simplified and focused on neutral risk perception. The representations and formulations are based on the findings from research on evidence-based patient information and risk communication. The package insert contains the same information as the statutory package insert to ensure that it complies with the legal requirements.
- Verbal information about side effects: The patient is informed verbally about side effects and does not receive any package insert.
Control Package insert according to EU (European Union) Directive 2001/83 / EC (European Commission) (usual package insert).
Outcomes
- Number of patient reported adverse events (primary outcome).
- Adherence (correct initiation of therapy, correct intake amount, premature discontinuation of therapy).
- Resource use (e.g. provider contacts).
Type of study Monocentric, outcome assessor, three-arm, randomised controlled pilot trial.
研究概览
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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North-Rhine-Westfalia
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Cologne、North-Rhine-Westfalia、德国、51109
- Clinic for orthopedics, trauma surgery and sports traumatology, hospital Cologne Merheim
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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:
- elective orthopaedic surgery
- planned intake of ibuprofen 600 mg to treat postoperative pain
- postoperative pain medication other than Ibuprofen 600 (Opioids, Opiate, Paracetamol) no longer than 1-2 days postoperative (until discharge)
- at least 18 years
- able to speak German
- no cognitive deficits
- written informed consent
Exclusion Criteria:
- serious comorbidity
- pain medication prior to surgery
- other medication with similar side effects
- polytrauma
- planned inpatient rehabilitation > one week after hospital discharge
学习计划
研究是如何设计的?
设计细节
- 主要用途:卫生服务研究
- 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:Modified Package Insert
Simplified and focused on neutral risk perception.
The representations and formulations are based on the findings from research on evidence-based patient information and risk communication.
The package insert contains the same information as the statutory package insert to ensure that it complies with the legal requirements.
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Modified package insert of Ibuprofen given postprocedural as pain medication
其他名称:
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无干预:Verbal Information
The patient is informed verbally about side effects and does not receive any package insert.
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有源比较器:Control
Package insert according to EU Directive 2001/83 / EC (usual package insert)
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Modified package insert of Ibuprofen given postprocedural as pain medication
其他名称:
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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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Number of patient reported adverse events
大体时间:6-9 days after surgery
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Any reported adverse events
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6-9 days after surgery
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Adherence
大体时间:6-9 days after surgery
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Correct initiation of therapy, correct intake amount, premature discontinuation of therapy
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6-9 days after surgery
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Resource use
大体时间:6-9 days after surgery
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e.g. provider contacts
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6-9 days after surgery
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合作者和调查者
调查人员
- 首席研究员:Tim Mathes, Dr.、Witten/Herdecke University
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 (预期的)
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
关键字
其他研究编号
- V01-01
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
IPD 共享时间框架
IPD 共享访问标准
IPD 共享支持信息类型
- 研究方案
- 企业社会责任
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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Package Insert的临床试验
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Medical University of GrazMedical University of Vienna; Medical University Innsbruck; Klinikum Klagenfurt am Wörthersee; University... 和其他合作者未知