<clinical_study>
  <!-- This xml conforms to an XML Schema at:
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  <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/NCT02222064</url>
  </required_header>
  <id_info>
    <org_study_id>14/0190</org_study_id>
    <nct_id>NCT02222064</nct_id>
  </id_info>
  <brief_title>Pilot of Mindfulness Therapy for Inpatients With Gastro-intestinal Pain</brief_title>
  <official_title>Exploratory Study of Mindfulness for Inpatients With Chronic Gastrointestinal Pain: Does it Reduce Pain Related Distress and Increase Confidence in Pain Self-management?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University College, London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University College, London</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Research questions/hypotheses&#xD;
&#xD;
        1. Can an individual mindfulness intervention for Gastro Intestinal Failure inpatients&#xD;
           reduce pain-related distress, improve quality of life, and increase confidence in pain&#xD;
           self-management?&#xD;
&#xD;
        2. How useful and applicable do Gastro Intestinal Failure inpatients find Mindfulness&#xD;
           methods?&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in pain distress rating on 11 point numerical rating scale</measure>
    <time_frame>Baseline, week 1, week 2, week 3, week 4, week 5 , week 6, week 7, week 8</time_frame>
    <description>A numerical rating scale scored from 0 to 10 which asks &quot;how distressing is the pain on average in the last week with 0 being not distressing at all and 10 being extreme distress&quot;</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hospital Anxiety and Depression Scale</measure>
    <time_frame>At baseline, week 8</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Self Efficacy Questionnaire</measure>
    <time_frame>At baseline, week 8</time_frame>
    <description>a 10 item scale that attempts to capture a measure of individual's confidence in being active despite pain, rated on a numerical scale from 0 &quot;not at all confident&quot; to 6 &quot;completely confident&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chronic Pain Acceptance Questionnaire</measure>
    <time_frame>At baseline, week 8</time_frame>
    <description>a 20 item measure included to provide a rating of acceptance of pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Five Facet Mindfulness Questionnaire</measure>
    <time_frame>At baseline, week 8</time_frame>
    <description>a 39 item questionnaire which has been developed from five mindfulness questionnaires using exploratory factor analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-report record of using mindfulness exercises (frequency and duration)</measure>
    <time_frame>Week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brief account of experience of pain and doing the mindfulness exercises</measure>
    <time_frame>Week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8</time_frame>
    <description>participants will be asked to write a brief (&lt;1 page) account of their experience of their pain and of doing the mindfulness exercises over the preceding week</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in pain intensity rating on 11 point numerical rating scale</measure>
    <time_frame>Baseline, week 1, week 2, week 3, week 4, week 5 , week 6, week 7, week 8</time_frame>
    <description>A numerical rating scale scored from 0 to 10 which asks &quot;how intense is the pain on average in the last week with 0 being no pain and 10 being extreme pain&quot;</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Gastro-intestinal Pain</condition>
  <arm_group>
    <arm_group_label>Mindfulness</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>8 week self-managed mindfulness based intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mindfulness</intervention_name>
    <description>Mindfulness is a psychological intervention based on increasing skills of non-judgemental awareness using meditations. In this study a self-directed 8 week course of mindfulness will be used involving self-help materials in the form of a book and 8 guided meditations on audio files.</description>
    <arm_group_label>Mindfulness</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  &gt;18 years, pain experienced&#xD;
&#xD;
          -  &gt;3 months, proficiency in English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous mindfulness experience&#xD;
&#xD;
          -  severe cognitive impairment&#xD;
&#xD;
          -  profound hearing difficulties&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University College Hospital</name>
      <address>
        <city>London</city>
        <zip>NW1 2BU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>August 12, 2014</study_first_submitted>
  <study_first_submitted_qc>August 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2014</study_first_posted>
  <last_update_submitted>December 3, 2015</last_update_submitted>
  <last_update_submitted_qc>December 3, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 4, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02222064
org study id: 14/0190
nct id: NCT02222064
lead sponsor: 
has dmc: No
Research questions/hypotheses

        1. Can an individual mindfulness intervention for Gastro Intestinal Failure inpatients
           reduce pain-related distress, improve quality of life, and increase confidence in pain
           self-management?

        2. How useful and applicable do Gastro Intestinal Failure inpatients find Mindfulness
           methods?
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change in pain distress rating on 11 point numerical rating scale
time frame: Baseline, week 1, week 2, week 3, week 4, week 5 , week 6, week 7, week 8
description: A numerical rating scale scored from 0 to 10 which asks "how distressing is the pain on average in the last week with 0 being not distressing at all and 10 being extreme distress"
measure: Hospital Anxiety and Depression Scale
time frame: At baseline, week 8
measure: Pain Self Efficacy Questionnaire
time frame: At baseline, week 8
description: a 10 item scale that attempts to capture a measure of individual's confidence in being active despite pain, rated on a numerical scale from 0 "not at all confident" to 6 "completely confident"
measure: Chronic Pain Acceptance Questionnaire
time frame: At baseline, week 8
description: a 20 item measure included to provide a rating of acceptance of pain
measure: Five Facet Mindfulness Questionnaire
time frame: At baseline, week 8
description: a 39 item questionnaire which has been developed from five mindfulness questionnaires using exploratory factor analysis
measure: Self-report record of using mindfulness exercises (frequency and duration)
time frame: Week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8
measure: Brief account of experience of pain and doing the mindfulness exercises
time frame: Week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8
description: participants will be asked to write a brief (<1 page) account of their experience of their pain and of doing the mindfulness exercises over the preceding week
measure: Change in pain intensity rating on 11 point numerical rating scale
time frame: Baseline, week 1, week 2, week 3, week 4, week 5 , week 6, week 7, week 8
description: A numerical rating scale scored from 0 to 10 which asks "how intense is the pain on average in the last week with 0 being no pain and 10 being extreme pain"
arm group label: Mindfulness
arm group type: Experimental
description: 8 week self-managed mindfulness based intervention
intervention type: Behavioral
intervention name: Mindfulness
description: Mindfulness is a psychological intervention based on increasing skills of non-judgemental awareness using meditations. In this study a self-directed 8 week course of mindfulness will be used involving self-help materials in the form of a book and 8 guided meditations on audio files.
arm group label: Mindfulness
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United Kingdom
responsible party type: Sponsor