The Effect of Questionnaire Content on Measures of Pain Intensity, Magnitude of Disability, and Symptoms of Depression in Patients With Arm Illness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 168
- 试验地点
- 2
- 主要终点
- Patient Reported Outcomes Measurement Information System (PROMIS) Upper Extremity
研究概览
简要总结
The investigators plan a prospective randomized study to see whether negative questions affect measures of mood, pain, or disability. A total of 175 patients will participate at Massachusetts General Hospital.
详细描述
Patient mood, pain intensity, and magnitude of disability can be measured using questionnaires. The Pain Catastrophizing Scale (PCS) was developed to measure the extent to which the ineffective coping strategy of catastrophic thinking impacts pain experience. It is currently one of the most widely used measures of catastrophic thinking related to pain. The PCS instructions ask participants to reflect on past painful experiences, and to indicate the degree to which they experienced 13 thoughts or feelings when experiencing pain. The questions in the PCS are negatively phrased, e.g. "it's terrible and I think it's never going to get any better."
The effect by which exposure to a stimulus influences a response to a later response is called "priming." Priming is the process of activating particular representations or associations in memory just before carrying out an action or task. Priming affects all aspects of human behavior. For example, syntactic priming is the tendency to use syntactic structures that parallel the structures of sentences we have heard recently: a speaker who has just heard a sentence in passive voice is subsequently more likely to use a passive construction himself.
Priming apparently also has affective dimensions. Zajonc performed an experiment where he showed a list of Chinese characters to his test subjects. He subsequently showed the subjects a list of Chinese words and asked them which words they "liked the best." The words containing characters presented in the first list were evaluated more positively. The negative questions in the PCS may prime patients to be more negative in subsequent questionnaires.
Our group has performed multiple studies on the use of certain words, phrases, and concepts in hand and upper extremity surgery. Bossen et al showed that positive or negative wording of MRI reports influences patients' emotional response, satisfaction, and understanding. We are interested in looking at the possibility that certain questionnaires can affect other questionnaires via a priming effect.
We propose a three-arm single blind, randomized (1:1:1) controlled trial to assess whether negative questions of the PCS affect measures of mood, pain, or disability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All new and follow-up patients presenting to the Orthopaedic Hand and Upper Extremity Service
- •English fluency and literacy
排除标准
- •pregnant women
- •Inability to complete enrollment forms due to any mental status or language problems (e.g. dementia, head injury, overall illness).
研究组 & 干预措施
Intervention Group 1
The first intervention group will be comprised of patients who will complete PROMIS Upper Extremity Function, pain intensity, PROMIS depression, and the Positive affect negative affect scale (PANAS) after completing the standard PCS.
干预措施: Pain intensity (Other)
Intervention Group 1
The first intervention group will be comprised of patients who will complete PROMIS Upper Extremity Function, pain intensity, PROMIS depression, and the Positive affect negative affect scale (PANAS) after completing the standard PCS.
干预措施: PROMIS depression (Other)
Intervention Group 1
The first intervention group will be comprised of patients who will complete PROMIS Upper Extremity Function, pain intensity, PROMIS depression, and the Positive affect negative affect scale (PANAS) after completing the standard PCS.
干预措施: Positive affect negative affect scale (PANAS) (Other)
Intervention Group 1
The first intervention group will be comprised of patients who will complete PROMIS Upper Extremity Function, pain intensity, PROMIS depression, and the Positive affect negative affect scale (PANAS) after completing the standard PCS.
干预措施: standard PCS (Other)
Intervention Group 1
The first intervention group will be comprised of patients who will complete PROMIS Upper Extremity Function, pain intensity, PROMIS depression, and the Positive affect negative affect scale (PANAS) after completing the standard PCS.
干预措施: PROMIS Upper Extremity Function (Other)
Intervention Group 2
The second intervention group will be comprised of patients who will complete PROMIS Upper Extremity Function, pain intensity, PROMIS depression, and the Positive affect negative affect scale (PANAS) after completing a positively-adjusted version of the PCS.
干预措施: positively-adjusted version of the PCS (Other)
Intervention Group 2
The second intervention group will be comprised of patients who will complete PROMIS Upper Extremity Function, pain intensity, PROMIS depression, and the Positive affect negative affect scale (PANAS) after completing a positively-adjusted version of the PCS.
干预措施: PROMIS Upper Extremity Function (Other)
Intervention Group 2
The second intervention group will be comprised of patients who will complete PROMIS Upper Extremity Function, pain intensity, PROMIS depression, and the Positive affect negative affect scale (PANAS) after completing a positively-adjusted version of the PCS.
干预措施: Pain intensity (Other)
Intervention Group 2
The second intervention group will be comprised of patients who will complete PROMIS Upper Extremity Function, pain intensity, PROMIS depression, and the Positive affect negative affect scale (PANAS) after completing a positively-adjusted version of the PCS.
干预措施: PROMIS depression (Other)
Intervention Group 2
The second intervention group will be comprised of patients who will complete PROMIS Upper Extremity Function, pain intensity, PROMIS depression, and the Positive affect negative affect scale (PANAS) after completing a positively-adjusted version of the PCS.
干预措施: Positive affect negative affect scale (PANAS) (Other)
Control
The third group (the control arm) will complete PROMIS Upper Extremity Function, pain intensity, PROMIS depression, and the Positive affect negative affect scale (PANAS).
干预措施: Pain intensity (Other)
Control
The third group (the control arm) will complete PROMIS Upper Extremity Function, pain intensity, PROMIS depression, and the Positive affect negative affect scale (PANAS).
干预措施: PROMIS depression (Other)
Control
The third group (the control arm) will complete PROMIS Upper Extremity Function, pain intensity, PROMIS depression, and the Positive affect negative affect scale (PANAS).
干预措施: Positive affect negative affect scale (PANAS) (Other)
Control
The third group (the control arm) will complete PROMIS Upper Extremity Function, pain intensity, PROMIS depression, and the Positive affect negative affect scale (PANAS).
干预措施: PROMIS Upper Extremity Function (Other)
结局指标
主要结局
Patient Reported Outcomes Measurement Information System (PROMIS) Upper Extremity
时间窗: 1day
A computerized assessment of upper extremity physical function measured at enrollment. The average T score of the U.S. population is 50, so the T score reported compares the study population to the U.S. population, where a T score greater than 50 is better than the average and a T score less than 50 is worse than the average.
次要结局
- Patient Reported Outcomes Measurement Information System (PROMIS) Depression(1 day)
- Pain Intensity(1 day)
研究者
David C. Ring, MD
Principal Investigator
Massachusetts General Hospital