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The Effect of Priming of Questionnaire Content on Grip Strength in Patients With Hand and Upper Extremity Illness

2017年3月1日 更新者：David C. Ring, MD、Massachusetts General Hospital

Objectives:

To determine the association between priming and measurements of hand function such as grip strength

Primary null hypothesis:

There is no difference in grip strength (best of three attempts) as a percent of the opposite hand between patients that complete the standard Pain Catastrophizing Scale (PCS) compared to patients that complete the positively adjusted PCS.

Secondary null hypotheses:

There is no difference in grip strength (last of three attempts) as a percent of the opposite hand between patients that complete the standard PCS compared to patients that complete the positively adjusted PCS.

There is no difference in grip strength (best of three attempts) before and after completing the questionnaires between patients that complete the standard PCS compared to patients that complete the positively adjusted PCS.

研究概览

地位

完全的

条件

干预/治疗

详细说明

Priming affects all aspects of human behavior. Prior research by the investigators' group determined that completing a positively phrased version of the pain catastrophizing scale (PCS) primed patients to report less disability on average than completing the standard PCS. The influence of priming can be better understood by determining if it also affects direct measurements of hand function such as grip strength measures.

研究类型

介入性

注册 (实际的)

122

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Massachusetts
      • Boston、Massachusetts、美国、02114
        • Massachusetts General Hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • All English-speaking adult patients visiting the Orthopaedic Hand and Upper Extremity Service

Exclusion Criteria:

  • Unable to complete enrollment forms due to mental status or language problem

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：Standard PCS
Grip strength measurements and completes standard PCS
其他：Standard PCS
Subject completes the standard version of the PCS Questionnaire
其他：Grip Strength
Research Assistant takes Grip Strength Measurements
实验性的：Positive PCS
Grip strength measurements and completes positively adjusted PCS
其他：Grip Strength
Research Assistant takes Grip Strength Measurements
其他：Positively Adjusted PCS
Subject completes the positively-adjusted version of the PCS Questionnaire

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
Pain Catastrophizing Scale (PCS)
大体时间：enrollment
The pain catastrophizing scale is a 13-item scale to measure catastrophic thinking. The scale is from 0-4 and scores range from 0-52, a lower score indicates less catastrophic thinking about pain.
enrollment
Positive Pain Catastrophizing Scale (PCS)
大体时间：enrollment
The positive pain catastrophizing scale (PCS) is a positively-phrased 13-item scale to measure catastrophic thinking. The scale is from 0-4 and scores range from 0-52, a higher score indicates less catastrophic thinking about pain.
enrollment
Difference in Grip Strength Measured With Dynamometer
大体时间：Day 1
Difference in Grip strength of the non-affected hand after completing intervention. Each participant completed the grip strength measurement 3 times on the non-affected hand at enrollment (day 1). The results reported represent an increase or decrease in mean grip strength and maximum grip strength after completing the intervention.
Day 1
Difference in Grip Strength Measured With Dynamometer
大体时间：Day 1
Difference in Grip strength of the injured hand after completing intervention. Each participant completed the grip strength measurement 3 times on the injured hand at enrollment (day 1). The results reported represent an increase or decrease in mean grip strength and maximum grip strength after completing the intervention.
Day 1
Difference in Grip Strength Measured With Dynamometer
大体时间：Day 1
Difference in Grip strength of both hands after completing intervention. Each participant completed the grip strength measurement 3 times with both hands at enrollment (day 1). The results reported represent an increase or decrease in mean grip strength and maximum grip strength after completing the intervention.
Day 1

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Massachusetts General Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2015年6月1日

初级完成 (实际的)

2015年8月1日

研究完成 (实际的)

2015年8月1日

研究注册日期

首次提交

2015年6月15日

首先提交符合 QC 标准的

2015年7月8日

首次发布 (估计)

2015年7月9日

研究记录更新

最后更新发布 (实际的)

2017年4月13日

上次提交的符合 QC 标准的更新

2017年3月1日

最后验证

2017年3月1日

更多信息

与本研究相关的术语

其他研究编号

  • 2015P000879

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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