<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/NCT04477278</url>
  </required_header>
  <id_info>
    <org_study_id>IRB_00116896</org_study_id>
    <nct_id>NCT04477278</nct_id>
  </id_info>
  <brief_title>Examining the Impact of Mindfulness on Patients' Experience of Osteopathic Manipulation</brief_title>
  <official_title>Examining the Impact of Mindfulness on Patients' Experience of Osteopathic Manipulation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Utah</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Utah</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a single site, two-arm, parallel group pilot randomized controlled trial examining&#xD;
      the effect of coupling a brief mindfulness-based intervention with an osteopathic&#xD;
      manipulation session for pain patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 25, 2019</start_date>
  <completion_date type="Actual">June 23, 2020</completion_date>
  <primary_completion_date type="Actual">September 16, 2019</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>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Pain Intensity from immediately before session to immediately after</measure>
    <time_frame>Immediately before and after the osteopathic manipulation session (i.e., 1 hour)</time_frame>
    <description>Pain intensity was measured with individual items rated on a numeric rating scale (0-10). Higher scores indicate more pain.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Sensation Ratio (Pleasant/Unpleasant) from immediately before session to immediately after</measure>
    <time_frame>Immediately before and after the osteopathic manipulation session (i.e., 1 hour)</time_frame>
    <description>The sensation manikin is a digital human figure silhouette that is overlaid with a grid of 786 &quot;sensation&quot; pixels. Participants identify locations (i.e., grid pixels) on the manikin where they feel both pleasant and unpleasant sensations. Clicking once on any grid pixel turns that location blue, indicating a pleasant sensation. Clicking twice on any grid pixel turns that location red, indicating an unpleasant sensation. Each participant was instructed to color the entire area in which they were currently feeling sensation in their body. A clinically useful sensation ratio score is achieved by dividing the number of pleasant sensation pixels reported by the number of unpleasant sensation pixels reported. Higher scores indicate a larger pleasant sensation to unpleasant sensation ratio.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction</measure>
    <time_frame>Immediately after the osteopathic manipulation session</time_frame>
    <description>Session satisfaction was measured with an individual item (&quot;I am satisfied with my treatment session.&quot;) rated on a numeric rating scale (0-10). Higher scores indicate greater satisfaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Mindfulness of the Body from immediately before pre-session audio recording to immediately after</measure>
    <time_frame>Immediately before and after the pre-session audio recording (i.e., 10 minutes)</time_frame>
    <description>Mindfulness of the body was measured with an individual item (&quot;I felt in contact with my body&quot;) from the State Mindfulness Scale (Tanay &amp; Bernstein, 2013) rated on a numeric rating scale (0-10). Higher scores indicate more mindfulness of the body.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Embodied Safety from immediately before pre-session audio recording to immediately after</measure>
    <time_frame>Immediately before and after the pre-session audio recording (i.e., 10 minutes)</time_frame>
    <description>Embodied safety was measured with an individual item (&quot;I felt my body was a safe place.&quot;), from the Multidimensional Assessment of Interoceptive Awareness (Mehling et al., 2012) rated on a numeric rating scale (0-10). Higher scores indicate greater embodied safety.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">39</enrollment>
  <condition>Pain</condition>
  <condition>Satisfaction, Patient</condition>
  <arm_group>
    <arm_group_label>Audio-Guided Mindfulness Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Brief, 8-minute, audio-guided mindfulness intervention delivered prior to osteopathic manipulation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>History of Osteopathy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Brief, 8-minute, audio-guided history of osteopathy delivered prior to osteopathic manipulation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mindfulness Meditation</intervention_name>
    <description>The mindfulness meditation recording consisted of instruction in focused attention on breath and body sensations and metacognitive monitoring and acceptance of discursive thoughts, negative emotions, and pain.</description>
    <arm_group_label>Audio-Guided Mindfulness Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>History of Osteopathy</intervention_name>
    <description>The history of osteopathy recording introduced patients to the founder of osteopathy, Andrew Taylor Still, and his philosophy of healing.</description>
    <arm_group_label>History of Osteopathy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients scheduled for OMT at the Huntsman Cancer Institute&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Altered mental status due to delirium, psychosis, or medication sedation as determined&#xD;
             by treating clinician.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Utah</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>July 15, 2020</last_update_submitted>
  <last_update_submitted_qc>July 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Utah</investigator_affiliation>
    <investigator_full_name>Adam Hanley</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Data will be made available to qualified applicants upon receipt of worthy project proposal</ipd_description>
  </patient_data>
  <!-- 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/NCT04477278
org study id: IRB_00116896
nct id: NCT04477278
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a single site, two-arm, parallel group pilot randomized controlled trial examining
      the effect of coupling a brief mindfulness-based intervention with an osteopathic
      manipulation session for pain patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Care Provider, Investigator, Outcomes Assessor)
measure: Change in Pain Intensity from immediately before session to immediately after
time frame: Immediately before and after the osteopathic manipulation session (i.e., 1 hour)
description: Pain intensity was measured with individual items rated on a numeric rating scale (0-10). Higher scores indicate more pain.
measure: Change in Sensation Ratio (Pleasant/Unpleasant) from immediately before session to immediately after
time frame: Immediately before and after the osteopathic manipulation session (i.e., 1 hour)
description: The sensation manikin is a digital human figure silhouette that is overlaid with a grid of 786 "sensation" pixels. Participants identify locations (i.e., grid pixels) on the manikin where they feel both pleasant and unpleasant sensations. Clicking once on any grid pixel turns that location blue, indicating a pleasant sensation. Clicking twice on any grid pixel turns that location red, indicating an unpleasant sensation. Each participant was instructed to color the entire area in which they were currently feeling sensation in their body. A clinically useful sensation ratio score is achieved by dividing the number of pleasant sensation pixels reported by the number of unpleasant sensation pixels reported. Higher scores indicate a larger pleasant sensation to unpleasant sensation ratio.
measure: Patient Satisfaction
time frame: Immediately after the osteopathic manipulation session
description: Session satisfaction was measured with an individual item ("I am satisfied with my treatment session.") rated on a numeric rating scale (0-10). Higher scores indicate greater satisfaction.
measure: Change in Mindfulness of the Body from immediately before pre-session audio recording to immediately after
time frame: Immediately before and after the pre-session audio recording (i.e., 10 minutes)
description: Mindfulness of the body was measured with an individual item ("I felt in contact with my body") from the State Mindfulness Scale (Tanay & Bernstein, 2013) rated on a numeric rating scale (0-10). Higher scores indicate more mindfulness of the body.
measure: Change in Embodied Safety from immediately before pre-session audio recording to immediately after
time frame: Immediately before and after the pre-session audio recording (i.e., 10 minutes)
description: Embodied safety was measured with an individual item ("I felt my body was a safe place."), from the Multidimensional Assessment of Interoceptive Awareness (Mehling et al., 2012) rated on a numeric rating scale (0-10). Higher scores indicate greater embodied safety.
arm group label: Audio-Guided Mindfulness Intervention
arm group type: Experimental
description: Brief, 8-minute, audio-guided mindfulness intervention delivered prior to osteopathic manipulation.
arm group label: History of Osteopathy
arm group type: Active Comparator
description: Brief, 8-minute, audio-guided history of osteopathy delivered prior to osteopathic manipulation.
intervention type: Behavioral
intervention name: Mindfulness Meditation
description: The mindfulness meditation recording consisted of instruction in focused attention on breath and body sensations and metacognitive monitoring and acceptance of discursive thoughts, negative emotions, and pain.
arm group label: Audio-Guided Mindfulness Intervention
intervention type: Behavioral
intervention name: History of Osteopathy
description: The history of osteopathy recording introduced patients to the founder of osteopathy, Andrew Taylor Still, and his philosophy of healing.
arm group label: History of Osteopathy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Utah
investigator full name: Adam Hanley
investigator title: Assistant Professor
sharing ipd: Undecided
ipd description: Data will be made available to qualified applicants upon receipt of worthy project proposal