Ignite Creation Date:
2025-12-24 @ 2:23 PM
Ignite Modification Date:
2026-01-04 @ 4:41 AM
Study NCT ID:
NCT02209259
Status:
COMPLETED
Last Update Posted:
2018-05-14
First Post:
2014-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Effect of Questionnaire Content on Measures of Pain Intensity, Magnitude of Disability, and Symptoms of Depression in Patients With Arm Illness
Sponsor:
Massachusetts General Hospital
Organization:
Study Overview
Official Title:
The Effect of Questionnaire Content on Measures of Pain Intensity, Magnitude of Disability, and Symptoms of Depression in Patients With Arm Illness
Status:
COMPLETED
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
Aim:
The aim of this study is to assess whether the negative questions in the PCS affect measures of mood, pain, or disability.
Primary null hypothesis:
There is no difference in Patient Reported Outcomes Measurement Information System (PROMIS) Upper Extremity Function between patients who complete the standard PCS, patients who complete the positively adjusted PCS, and patients who do not complete the PCS.
Secondary null hypothesis:
There is no difference in pain intensity, PROMIS depression, and (Positive Affect Negative Affect Scale) PANAS scores between patients who complete the standard PCS, patients who complete the positively adjusted PCS, and patient who do not complete the PCS.
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.
Aim:
The aim of this study is to assess whether the negative questions in the PCS affect measures of mood, pain, or disability.
Primary null hypothesis:
There is no difference in Patient Reported Outcomes Measurement Information System (PROMIS) Upper Extremity Function between patients who complete the standard PCS, patients who complete the positively adjusted PCS, and patients who do not complete the PCS.
Secondary null hypothesis:
There is no difference in pain intensity, PROMIS depression, and (Positive Affect Negative Affect Scale) PANAS scores between patients who complete the standard PCS, patients who complete the positively adjusted PCS, and patient who do not complete the PCS.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: