Arm Illness
Conditions
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.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
* All new and follow-up patients presenting to the Orthopaedic Hand and Upper Extremity Service * English fluency and literacy
Exclusion criteria
* pregnant women * Inability to complete enrollment forms due to any mental status or language problems (e.g. dementia, head injury, overall illness).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Reported Outcomes Measurement Information System (PROMIS) Upper Extremity | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity | 1 day | 10 point pain scale, where 0 is no pain and 10 is the most pain |
| Patient Reported Outcomes Measurement Information System (PROMIS) Depression | 1 day | A computerized assessment of depression 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 worse than the average and a T score less than 50 is better than the average. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard PCS The first intervention group will be comprised of patients who will complete the standard PCS. | 56 |
| Positively-adjusted PCS The second intervention group will be comprised of patients who will complete a positively-adjusted version of the PCS. | 56 |
| Control The third group (the control arm) will not complete the PCS. | 56 |
| Total | 168 |
Baseline characteristics
| Characteristic | Standard PCS | Total | Control | Positively-adjusted PCS |
|---|---|---|---|---|
| Age, Continuous | 53 years STANDARD_DEVIATION 16 | 52 years STANDARD_DEVIATION 17 | 56 years STANDARD_DEVIATION 15 | 51 years STANDARD_DEVIATION 18 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 8 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 6 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 11 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 47 Participants | 143 Participants | 50 Participants | 46 Participants |
| Region of Enrollment United States | 56 participants | 168 participants | 56 participants | 56 participants |
| Sex: Female, Male Female | 27 Participants | 89 Participants | 28 Participants | 34 Participants |
| Sex: Female, Male Male | 29 Participants | 79 Participants | 28 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 56 | 0 / 56 | 0 / 56 |
| other Total, other adverse events | 0 / 56 | 0 / 56 | 0 / 56 |
| serious Total, serious adverse events | 0 / 56 | 0 / 56 | 0 / 56 |
Outcome results
Patient Reported Outcomes Measurement Information System (PROMIS) Upper Extremity
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.
Time frame: 1day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard PCS | Patient Reported Outcomes Measurement Information System (PROMIS) Upper Extremity | 39 T-score | Standard Deviation 9.8 |
| Positively-adjusted PCS | Patient Reported Outcomes Measurement Information System (PROMIS) Upper Extremity | 43 T-score | Standard Deviation 8.1 |
| Control | Patient Reported Outcomes Measurement Information System (PROMIS) Upper Extremity | 41 T-score | Standard Deviation 11 |
Pain Intensity
10 point pain scale, where 0 is no pain and 10 is the most pain
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard PCS | Pain Intensity | 3.5 units on a scale | Standard Deviation 3 |
| Positively-adjusted PCS | Pain Intensity | 3.5 units on a scale | Standard Deviation 2.9 |
| Control | Pain Intensity | 3.3 units on a scale | Standard Deviation 2.9 |
Patient Reported Outcomes Measurement Information System (PROMIS) Depression
A computerized assessment of depression 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 worse than the average and a T score less than 50 is better than the average.
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard PCS | Patient Reported Outcomes Measurement Information System (PROMIS) Depression | 47 T-score | Standard Deviation 8.4 |
| Positively-adjusted PCS | Patient Reported Outcomes Measurement Information System (PROMIS) Depression | 48 T-score | Standard Deviation 7.9 |
| Control | Patient Reported Outcomes Measurement Information System (PROMIS) Depression | 48 T-score | Standard Deviation 8.5 |