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

NCT ID: NCT02209259

Last Updated: 2018-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 168 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2016-02-29

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.

Conditions

Arm Illness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

PROMIS Upper Extremity Function

Intervention Type: OTHER

Pain intensity

Intervention Type: OTHER

PROMIS depression

Intervention Type: OTHER

Positive affect negative affect scale (PANAS)

Intervention Type: OTHER

standard PCS

Intervention Type: 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.

Group Type: EXPERIMENTAL

PROMIS Upper Extremity Function

Intervention Type: OTHER

Pain intensity

Intervention Type: OTHER

PROMIS depression

Intervention Type: OTHER

Positive affect negative affect scale (PANAS)

Intervention Type: OTHER

positively-adjusted version of the PCS

Intervention Type: 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).

Group Type: EXPERIMENTAL

PROMIS Upper Extremity Function

Intervention Type: OTHER

Pain intensity

Intervention Type: OTHER

PROMIS depression

Intervention Type: OTHER

Positive affect negative affect scale (PANAS)

Intervention Type: OTHER

Interventions

PROMIS Upper Extremity Function

Intervention Type: OTHER

Pain intensity

Intervention Type: OTHER

PROMIS depression

Intervention Type: OTHER

Positive affect negative affect scale (PANAS)

Intervention Type: OTHER

standard PCS

Intervention Type: OTHER

positively-adjusted version of the PCS

Intervention Type: OTHER

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

David C. Ring, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Ring, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

References

Sullivan M J L, Bishop S, Pivik J. The Pain Catastrophizing Scale: Development andvalidation. Psychol Assess 1995, 7: 524-532.

Reference Type: BACKGROUND

Zajonc, R.B. Mere exposure: A gateway to the subliminal. Current Directions in Psychological Science 2001, 10 (6): 224-228.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 23761176 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26683347 (View on PubMed)

Other Identifiers

2014P000666

Identifier Type: -

Identifier Source: org_study_id