NCT02209259|CompletedResults
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Sponsor study identifier
interventional
168
1 country
1
Study Start
May 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2016
Actual (reported)Study Completion
February 2016
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2014
Date type not reportedThis date has not been verified as actual or estimated.
July 29, 2014
Actual (reported)August 5, 2014
Actual (reported)February 2016
Actual (reported)February 2016
Actual (reported)May 14, 2018
Actual (reported)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.
1day
Pain Intensity
1 day
Patient Reported Outcomes Measurement Information System (PROMIS) Depression
1 day
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.
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Sullivan M J L, Bishop S, Pivik J. The Pain Catastrophizing Scale: Development andvalidation. Psychol Assess 1995, 7: 524-532.
Zajonc, R.B. Mere exposure: A gateway to the subliminal. Current Directions in Psychological Science 2001, 10 (6): 224-228.
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.
David Ring, MD, PhD
Massachusetts General Hospital
168 participants (actual enrollment reported by the registry).
First Submitted
July 29, 2014
First Posted
August 5, 2014
Study Start
May 2014
Date type not reportedThis date has not been verified as actual or estimated.
The third group (the control arm) will complete PROMIS Upper Extremity Function, pain intensity, PROMIS depression, and the Positive affect negative affect scale (PANAS).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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.
Primary Completion
February 2016
Actual (reported)Study Completion
February 2016
Actual (reported)Last Updated
May 14, 2018
Results First Posted
May 14, 2018
Record last verified: 2018-05
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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