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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

Primary Purpose

Arm Illness

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PROMIS Upper Extremity Function
Pain intensity
PROMIS depression
Positive affect negative affect scale (PANAS)
standard PCS
positively-adjusted version of the PCS
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arm Illness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Intervention Group 1

Intervention Group 2

Control

Arm Description

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.

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.

The third group (the control arm) will complete PROMIS Upper Extremity Function, pain intensity, PROMIS depression, and the Positive affect negative affect scale (PANAS).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
July 29, 2014
Last Updated
May 11, 2018
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02209259
Brief Title
The Effect of Questionnaire Content on Measures of Pain Intensity, Magnitude of Disability, and Symptoms of Depression in Patients With Arm Illness
Official Title
The Effect of Questionnaire Content on Measures of Pain Intensity, Magnitude of Disability, and Symptoms of Depression in Patients With Arm Illness
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arm Illness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
168 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Intervention Group 2
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Experimental
Arm Description
The third group (the control arm) will complete PROMIS Upper Extremity Function, pain intensity, PROMIS depression, and the Positive affect negative affect scale (PANAS).
Intervention Type
Other
Intervention Name(s)
PROMIS Upper Extremity Function
Intervention Type
Other
Intervention Name(s)
Pain intensity
Intervention Type
Other
Intervention Name(s)
PROMIS depression
Intervention Type
Other
Intervention Name(s)
Positive affect negative affect scale (PANAS)
Intervention Type
Other
Intervention Name(s)
standard PCS
Intervention Type
Other
Intervention Name(s)
positively-adjusted version of the PCS
Primary Outcome Measure Information:
Title
Patient Reported Outcomes Measurement Information System (PROMIS) Upper Extremity
Description
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
Secondary Outcome Measure Information:
Title
Pain Intensity
Description
10 point pain scale, where 0 is no pain and 10 is the most pain
Time Frame
1 day
Title
Patient Reported Outcomes Measurement Information System (PROMIS) Depression
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Ring, MD, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Citations:
Citation
Sullivan M J L, Bishop S, Pivik J. The Pain Catastrophizing Scale: Development andvalidation. Psychol Assess 1995, 7: 524-532.
Results Reference
background
Citation
Zajonc, R.B. Mere exposure: A gateway to the subliminal. Current Directions in Psychological Science 2001, 10 (6): 224-228.
Results Reference
background
PubMed Identifier
23761176
Citation
Bossen JK, Hageman MG, King JD, Ring DC. Does rewording MRI reports improve patient understanding and emotional response to a clinical report? Clin Orthop Relat Res. 2013 Nov;471(11):3637-44. doi: 10.1007/s11999-013-3100-x. Epub 2013 Jun 13.
Results Reference
background
PubMed Identifier
26683347
Citation
Claessen FM, Mellema JJ, Stoop N, Lubberts B, Ring D, Poolman RW. Influence of Priming on Patient-Reported Outcome Measures: A Randomized Controlled Trial. Psychosomatics. 2016 Jan-Feb;57(1):47-56. doi: 10.1016/j.psym.2015.09.005. Epub 2015 Oct 1.
Results Reference
derived

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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

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