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The Effect of Questionnaire Content on Measures of Pain Intensity, Magnitude of Disability, and Symptoms of Depression in Patients With Arm Illness

The Effect of Questionnaire Content on Measures of Pain Intensity, Magnitude of Disability, and Symptoms of Depression in Patients With Arm Illness

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02209259
Enrollment
168
Registered
2014-08-05
Start date
2014-05-31
Completion date
2016-02-29
Last updated
2018-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arm Illness

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

OTHERPROMIS Upper Extremity Function
OTHERPain intensity
OTHERPROMIS depression
OTHERPositive affect negative affect scale (PANAS)
OTHERpositively-adjusted version of the PCS

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
Patient Reported Outcomes Measurement Information System (PROMIS) Upper Extremity1dayA 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

MeasureTime frameDescription
Pain Intensity1 day10 point pain scale, where 0 is no pain and 10 is the most pain
Patient Reported Outcomes Measurement Information System (PROMIS) Depression1 dayA 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

ArmCount
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
Total168

Baseline characteristics

CharacteristicStandard PCSTotalControlPositively-adjusted PCS
Age, Continuous53 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 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
4 Participants8 Participants2 Participants2 Participants
Race (NIH/OMB)
Black or African American
3 Participants6 Participants1 Participants2 Participants
Race (NIH/OMB)
More than one race
2 Participants11 Participants3 Participants6 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
47 Participants143 Participants50 Participants46 Participants
Region of Enrollment
United States
56 participants168 participants56 participants56 participants
Sex: Female, Male
Female
27 Participants89 Participants28 Participants34 Participants
Sex: Female, Male
Male
29 Participants79 Participants28 Participants22 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 560 / 560 / 56
other
Total, other adverse events
0 / 560 / 560 / 56
serious
Total, serious adverse events
0 / 560 / 560 / 56

Outcome results

Primary

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

ArmMeasureValue (MEAN)Dispersion
Standard PCSPatient Reported Outcomes Measurement Information System (PROMIS) Upper Extremity39 T-scoreStandard Deviation 9.8
Positively-adjusted PCSPatient Reported Outcomes Measurement Information System (PROMIS) Upper Extremity43 T-scoreStandard Deviation 8.1
ControlPatient Reported Outcomes Measurement Information System (PROMIS) Upper Extremity41 T-scoreStandard Deviation 11
Secondary

Pain Intensity

10 point pain scale, where 0 is no pain and 10 is the most pain

Time frame: 1 day

ArmMeasureValue (MEAN)Dispersion
Standard PCSPain Intensity3.5 units on a scaleStandard Deviation 3
Positively-adjusted PCSPain Intensity3.5 units on a scaleStandard Deviation 2.9
ControlPain Intensity3.3 units on a scaleStandard Deviation 2.9
Secondary

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

ArmMeasureValue (MEAN)Dispersion
Standard PCSPatient Reported Outcomes Measurement Information System (PROMIS) Depression47 T-scoreStandard Deviation 8.4
Positively-adjusted PCSPatient Reported Outcomes Measurement Information System (PROMIS) Depression48 T-scoreStandard Deviation 7.9
ControlPatient Reported Outcomes Measurement Information System (PROMIS) Depression48 T-scoreStandard Deviation 8.5

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026