<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02209259</url>
  </required_header>
  <id_info>
    <org_study_id>2014P000666</org_study_id>
    <nct_id>NCT02209259</nct_id>
  </id_info>
  <brief_title>The Effect of Questionnaire Content on Measures of Pain Intensity, Magnitude of Disability, and Symptoms of Depression in Patients With Arm Illness</brief_title>
  <official_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>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators plan a prospective randomized study to see whether negative questions&#xD;
      affect measures of mood, pain, or disability. A total of 175 patients will participate at&#xD;
      Massachusetts General Hospital.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patient mood, pain intensity, and magnitude of disability can be measured using&#xD;
      questionnaires. The Pain Catastrophizing Scale (PCS) was developed to measure the extent to&#xD;
      which the ineffective coping strategy of catastrophic thinking impacts pain experience. It is&#xD;
      currently one of the most widely used measures of catastrophic thinking related to pain. The&#xD;
      PCS instructions ask participants to reflect on past painful experiences, and to indicate the&#xD;
      degree to which they experienced 13 thoughts or feelings when experiencing pain. The&#xD;
      questions in the PCS are negatively phrased, e.g. &quot;it's terrible and I think it's never going&#xD;
      to get any better.&quot;&#xD;
&#xD;
      The effect by which exposure to a stimulus influences a response to a later response is&#xD;
      called &quot;priming.&quot; Priming is the process of activating particular representations or&#xD;
      associations in memory just before carrying out an action or task. Priming affects all&#xD;
      aspects of human behavior. For example, syntactic priming is the tendency to use syntactic&#xD;
      structures that parallel the structures of sentences we have heard recently: a speaker who&#xD;
      has just heard a sentence in passive voice is subsequently more likely to use a passive&#xD;
      construction himself.&#xD;
&#xD;
      Priming apparently also has affective dimensions. Zajonc performed an experiment where he&#xD;
      showed a list of Chinese characters to his test subjects. He subsequently showed the subjects&#xD;
      a list of Chinese words and asked them which words they &quot;liked the best.&quot; The words&#xD;
      containing characters presented in the first list were evaluated more positively. The&#xD;
      negative questions in the PCS may prime patients to be more negative in subsequent&#xD;
      questionnaires.&#xD;
&#xD;
      Our group has performed multiple studies on the use of certain words, phrases, and concepts&#xD;
      in hand and upper extremity surgery. Bossen et al showed that positive or negative wording of&#xD;
      MRI reports influences patients' emotional response, satisfaction, and understanding. We are&#xD;
      interested in looking at the possibility that certain questionnaires can affect other&#xD;
      questionnaires via a priming effect.&#xD;
&#xD;
      We propose a three-arm single blind, randomized (1:1:1) controlled trial to assess whether&#xD;
      negative questions of the PCS affect measures of mood, pain, or disability.&#xD;
&#xD;
      Aim:&#xD;
&#xD;
      The aim of this study is to assess whether the negative questions in the PCS affect measures&#xD;
      of mood, pain, or disability.&#xD;
&#xD;
      Primary null hypothesis:&#xD;
&#xD;
      There is no difference in Patient Reported Outcomes Measurement Information System (PROMIS)&#xD;
      Upper Extremity Function between patients who complete the standard PCS, patients who&#xD;
      complete the positively adjusted PCS, and patients who do not complete the PCS.&#xD;
&#xD;
      Secondary null hypothesis:&#xD;
&#xD;
      There is no difference in pain intensity, PROMIS depression, and (Positive Affect Negative&#xD;
      Affect Scale) PANAS scores between patients who complete the standard PCS, patients who&#xD;
      complete the positively adjusted PCS, and patient who do not complete the PCS.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2014</start_date>
  <completion_date type="Actual">February 2016</completion_date>
  <primary_completion_date type="Actual">February 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient Reported Outcomes Measurement Information System (PROMIS) Upper Extremity</measure>
    <time_frame>1day</time_frame>
    <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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain Intensity</measure>
    <time_frame>1 day</time_frame>
    <description>10 point pain scale, where 0 is no pain and 10 is the most pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Reported Outcomes Measurement Information System (PROMIS) Depression</measure>
    <time_frame>1 day</time_frame>
    <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.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">168</enrollment>
  <condition>Arm Illness</condition>
  <arm_group>
    <arm_group_label>Intervention Group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention Group 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PROMIS Upper Extremity Function</intervention_name>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Intervention Group 1</arm_group_label>
    <arm_group_label>Intervention Group 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pain intensity</intervention_name>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Intervention Group 1</arm_group_label>
    <arm_group_label>Intervention Group 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PROMIS depression</intervention_name>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Intervention Group 1</arm_group_label>
    <arm_group_label>Intervention Group 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Positive affect negative affect scale (PANAS)</intervention_name>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Intervention Group 1</arm_group_label>
    <arm_group_label>Intervention Group 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>standard PCS</intervention_name>
    <arm_group_label>Intervention Group 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>positively-adjusted version of the PCS</intervention_name>
    <arm_group_label>Intervention Group 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All new and follow-up patients presenting to the Orthopaedic Hand and Upper Extremity&#xD;
             Service&#xD;
&#xD;
          -  English fluency and literacy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant women&#xD;
&#xD;
          -  Inability to complete enrollment forms due to any mental status or language problems&#xD;
             (e.g. dementia, head injury, overall illness).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Ring, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Sullivan M J L, Bishop S, Pivik J. The Pain Catastrophizing Scale: Development andvalidation. Psychol Assess 1995, 7: 524-532.</citation>
  </reference>
  <reference>
    <citation>Zajonc, R.B. Mere exposure: A gateway to the subliminal. Current Directions in Psychological Science 2001, 10 (6): 224-228.</citation>
  </reference>
  <reference>
    <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.</citation>
    <PMID>23761176</PMID>
  </reference>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>July 29, 2014</study_first_submitted>
  <study_first_submitted_qc>August 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 5, 2014</study_first_posted>
  <results_first_submitted>February 2, 2017</results_first_submitted>
  <results_first_submitted_qc>May 11, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">May 14, 2018</results_first_posted>
  <last_update_submitted>May 11, 2018</last_update_submitted>
  <last_update_submitted_qc>May 11, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 14, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>David C. Ring, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain</mesh_term>
    <mesh_term>Depression</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Standard PCS</title>
          <description>The first intervention group will be comprised of patients who will complete the standard PCS.</description>
        </group>
        <group group_id="P2">
          <title>Positively-adjusted PCS</title>
          <description>The second intervention group will be comprised of patients who will complete a positively-adjusted version of the PCS.</description>
        </group>
        <group group_id="P3">
          <title>Control</title>
          <description>The third group (the control arm) will not complete the PCS.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="56"/>
                <participants group_id="P2" count="56"/>
                <participants group_id="P3" count="56"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="56"/>
                <participants group_id="P2" count="56"/>
                <participants group_id="P3" count="56"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Standard PCS</title>
          <description>The first intervention group will be comprised of patients who will complete the standard PCS.</description>
        </group>
        <group group_id="B2">
          <title>Positively-adjusted PCS</title>
          <description>The second intervention group will be comprised of patients who will complete a positively-adjusted version of the PCS.</description>
        </group>
        <group group_id="B3">
          <title>Control</title>
          <description>The third group (the control arm) will not complete the PCS.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="56"/>
            <count group_id="B2" value="56"/>
            <count group_id="B3" value="56"/>
            <count group_id="B4" value="168"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53" spread="16"/>
                    <measurement group_id="B2" value="51" spread="18"/>
                    <measurement group_id="B3" value="56" spread="15"/>
                    <measurement group_id="B4" value="52" spread="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="28"/>
                    <measurement group_id="B4" value="89"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="28"/>
                    <measurement group_id="B4" value="79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="47"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="50"/>
                    <measurement group_id="B4" value="143"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="56"/>
                    <measurement group_id="B2" value="56"/>
                    <measurement group_id="B3" value="56"/>
                    <measurement group_id="B4" value="168"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Patient Reported Outcomes Measurement Information System (PROMIS) Upper Extremity</title>
        <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.</description>
        <time_frame>1day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard PCS</title>
            <description>The first intervention group will be comprised of patients who will complete the standard PCS.</description>
          </group>
          <group group_id="O2">
            <title>Positively-adjusted PCS</title>
            <description>The second intervention group will be comprised of patients who will complete a positively-adjusted version of the PCS.</description>
          </group>
          <group group_id="O3">
            <title>Control</title>
            <description>The third group (the control arm) will not complete the PCS.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Reported Outcomes Measurement Information System (PROMIS) Upper Extremity</title>
          <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.</description>
          <units>T-score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="56"/>
                <count group_id="O2" value="56"/>
                <count group_id="O3" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39" spread="9.8"/>
                    <measurement group_id="O2" value="43" spread="8.1"/>
                    <measurement group_id="O3" value="41" spread="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Intensity</title>
        <description>10 point pain scale, where 0 is no pain and 10 is the most pain</description>
        <time_frame>1 day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard PCS</title>
            <description>The first intervention group will be comprised of patients who will complete the standard PCS.</description>
          </group>
          <group group_id="O2">
            <title>Positively-adjusted PCS</title>
            <description>The second intervention group will be comprised of patients who will complete a positively-adjusted version of the PCS.</description>
          </group>
          <group group_id="O3">
            <title>Control</title>
            <description>The third group (the control arm) will not complete the PCS.</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Intensity</title>
          <description>10 point pain scale, where 0 is no pain and 10 is the most pain</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="56"/>
                <count group_id="O2" value="56"/>
                <count group_id="O3" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.5" spread="3.0"/>
                    <measurement group_id="O2" value="3.5" spread="2.9"/>
                    <measurement group_id="O3" value="3.3" spread="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Reported Outcomes Measurement Information System (PROMIS) Depression</title>
        <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.</description>
        <time_frame>1 day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard PCS</title>
            <description>The first intervention group will be comprised of patients who will complete the standard PCS.</description>
          </group>
          <group group_id="O2">
            <title>Positively-adjusted PCS</title>
            <description>The second intervention group will be comprised of patients who will complete a positively-adjusted version of the PCS.</description>
          </group>
          <group group_id="O3">
            <title>Control</title>
            <description>The third group (the control arm) will not complete the PCS.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Reported Outcomes Measurement Information System (PROMIS) Depression</title>
          <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.</description>
          <units>T-score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="56"/>
                <count group_id="O2" value="56"/>
                <count group_id="O3" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47" spread="8.4"/>
                    <measurement group_id="O2" value="48" spread="7.9"/>
                    <measurement group_id="O3" value="48" spread="8.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Standard PCS</title>
          <description>The first intervention group will be comprised of patients who will complete the standard PCS.</description>
        </group>
        <group group_id="E2">
          <title>Positively-adjusted PCS</title>
          <description>The second intervention group will be comprised of patients who will complete a positively-adjusted version of the PCS.</description>
        </group>
        <group group_id="E3">
          <title>Control</title>
          <description>The third group (the control arm) will not complete the PCS.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Taylor Pong</name_or_title>
      <organization>Massachusetts General Hospital</organization>
      <email>tpong1@partners.org</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02209259
org study id: 2014P000666
nct id: NCT02209259
lead sponsor: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Patient Reported Outcomes Measurement Information System (PROMIS) Upper Extremity
time frame: 1day
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.
measure: Pain Intensity
time frame: 1 day
description: 10 point pain scale, where 0 is no pain and 10 is the most pain
measure: Patient Reported Outcomes Measurement Information System (PROMIS) Depression
time frame: 1 day
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.
arm group label: Intervention Group 1
arm group type: Experimental
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 group label: Intervention Group 2
arm group type: Experimental
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 group label: Control
arm group type: Experimental
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: PROMIS Upper Extremity Function
arm group label: Control
arm group label: Intervention Group 1
arm group label: Intervention Group 2
intervention type: Other
intervention name: Pain intensity
arm group label: Control
arm group label: Intervention Group 1
arm group label: Intervention Group 2
intervention type: Other
intervention name: PROMIS depression
arm group label: Control
arm group label: Intervention Group 1
arm group label: Intervention Group 2
intervention type: Other
intervention name: Positive affect negative affect scale (PANAS)
arm group label: Control
arm group label: Intervention Group 1
arm group label: Intervention Group 2
intervention type: Other
intervention name: standard PCS
arm group label: Intervention Group 1
intervention type: Other
intervention name: positively-adjusted version of the PCS
arm group label: Intervention Group 2
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: David Ring, MD, PhD
role: Principal Investigator
affiliation: Massachusetts General Hospital
facility: 
country: United States
citation: Sullivan M J L, Bishop S, Pivik J. The Pain Catastrophizing Scale: Development andvalidation. Psychol Assess 1995, 7: 524-532.
citation: Zajonc, R.B. Mere exposure: A gateway to the subliminal. Current Directions in Psychological Science 2001, 10 (6): 224-228.
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.
PMID: 23761176
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: David C. Ring, MD
investigator title: Principal Investigator
mesh term: Pain
mesh term: Depression
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 