<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/NCT04424810</url>
  </required_header>
  <id_info>
    <org_study_id>20-0516</org_study_id>
    <nct_id>NCT04424810</nct_id>
  </id_info>
  <brief_title>Effect of High-quality Pre-operative Videos on Patient Anxiety Levels Prior to Ambulatory Hand Surgery</brief_title>
  <official_title>Effect of High-quality Pre-operative Videos on Patient Anxiety Levels Prior to Ambulatory Hand Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwell Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Northwell Health</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>
      Previous research has shown that YouTube is a poor source of high-quality medical&#xD;
      information. This is likely because there is no regulation of the content on YouTube and&#xD;
      relatively little of the content is posted by qualified medical professionals. It is known&#xD;
      that up to 30% of patients use the internet to research the procedure they will be having and&#xD;
      given the increasing popularity of YouTube we suspect many patients are using YouTube or&#xD;
      similar sites as a source of information prior to elective surgery. There are likely a number&#xD;
      of patient factors that contribute to patients seeking out videos as a source of&#xD;
      pre-operative medical information. Patient age, which is generally inversely correlated to&#xD;
      computer literacy, may have a role. Patient anxiety and pre-operative worrying may cause a&#xD;
      patient to turn to the internet to search for information, and the poor overall quality of&#xD;
      the content available may worsen pre-operative anxiety.&#xD;
&#xD;
      The primary objective of this study is to determine if providing patients with a reliable,&#xD;
      high-quality video about their condition and operation prior to surgery reduces pre-operative&#xD;
      anxiety. Secondary aims are to determine the percentage of patients that independently seek&#xD;
      out videos online as a source of medical information prior to elective hand surgery, identify&#xD;
      patient attributes that are associated with this behavior, and understand if introducing high&#xD;
      quality pre-surgical videos has an impact on post-operative patient outcomes and/or patient&#xD;
      engagement. The investigators hypothesize that providing patients with high-quality&#xD;
      pre-operative videos will reduce pre-operative anxiety. Its is also expected that patients&#xD;
      who seek out videos on their own for pre-operative medical information will be younger and&#xD;
      have higher anxiety levels and pain catastrophizing scores. Additionally, the investigators&#xD;
      hypothesize that patients who watch high-quality pre-operative videos may have better short&#xD;
      term post-operative outcomes and greater engagement in their care than their counterparts&#xD;
      that did not watch videos or who sought out videos on their own.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Actual">July 1, 2021</completion_date>
  <primary_completion_date type="Actual">July 1, 2021</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>
    <intervention_model_description>Parallel, 2 groups, 1:1 randomization</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pre-operative anxiety</measure>
    <time_frame>Immediately prior to surgery</time_frame>
    <description>We will measure pre-operative anxiety using the State-Trait Anxiety Inventory (STAI) 6-item short form (minimum score: 20, maximum score: 80, higher scores indicate more anxiety)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients who sought out pre-operative videos before surgery</measure>
    <time_frame>Immediately before surgery</time_frame>
    <description>We plan to determine the percentage of patients who sought out pre-operative videos before surgery on websites such as YouTube as a part of our &quot;video questionnaire&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain catastrophizing</measure>
    <time_frame>Immediately before surgery</time_frame>
    <description>As determined by the pain catastrophizing scale (PCS); (minimum score: 0, maximum score: 100, higher scores indicate more anxiety)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient engagement</measure>
    <time_frame>Immediately before surgery</time_frame>
    <description>To determine patient levels of engagement in their care as assessed by the Patient Activation Measure (PAM)-13 (minimum score: 0, maximum score: 100, higher scores indicate higher levels of activation/engagement in care)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain scores</measure>
    <time_frame>At 48-72 hour post-operatively and 2 weeks post-operatively</time_frame>
    <description>Assessed by Visual Analog Scale (VAS) pain scores (minimum: 0, maximum: 10, higher scores indicate greater levels of pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional outcomes</measure>
    <time_frame>At 48-72 hour post-operatively and 2 weeks post-operatively</time_frame>
    <description>Assessed by the Quick Disabilities of the Arm, Shoulder and Hand (qDASH) questionnaire (minimum: 0, maximum: 100, greater scores indicate a greater level of disability)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">167</enrollment>
  <condition>Anxiety</condition>
  <condition>Carpal Tunnel Syndrome</condition>
  <condition>Trigger Finger</condition>
  <condition>Engagement, Patient</condition>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Video group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients selected to be in the intervention group will be asked to watch a high-quality, physician created video describing their condition and the operative treatment they are about to undergo.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients selected to be in the control group will not be asked to watch a video prior to surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>High-quality, physician created video</intervention_name>
    <description>The intervention group will watch a short (2-5 minute) video prior to surgery that will provide them with information about their condition and the procedure they are about to undergo (either carpal tunnel release or trigger finger release).</description>
    <arm_group_label>Video group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard of care</intervention_name>
    <description>Patients in the control group will not be asked to do anything differently prior to their surgery</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  undergoing a primary routine elective hand procedure (Carpal tunnel release, trigger&#xD;
             finger release)&#xD;
&#xD;
          -  age &gt; 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  revision procedure&#xD;
&#xD;
          -  prior debilitating upper extremity injury&#xD;
&#xD;
          -  surgery not being performed on ambulatory basis&#xD;
&#xD;
          -  special populations (pregnant patients, prisoners or other institutionalized patients,&#xD;
             cognitive impairment)&#xD;
&#xD;
          -  non-english speaking patients (videos only available in english language)&#xD;
&#xD;
          -  age &lt; 18 years&#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>North Shore University Hospital, Schwartz Ambulatory Surgery Center</name>
      <address>
        <city>Manhasset</city>
        <state>New York</state>
        <zip>11030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>September 2, 2021</last_update_submitted>
  <last_update_submitted_qc>September 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwell Health</investigator_affiliation>
    <investigator_full_name>Christopher Larsen</investigator_full_name>
    <investigator_title>Physician, Department of Orthopaedic Surgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Trigger Finger Disorder</mesh_term>
    <mesh_term>Carpal Tunnel Syndrome</mesh_term>
    <mesh_term>Anxiety Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04424810
org study id: 20-0516
nct id: NCT04424810
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Previous research has shown that YouTube is a poor source of high-quality medical
      information. This is likely because there is no regulation of the content on YouTube and
      relatively little of the content is posted by qualified medical professionals. It is known
      that up to 30% of patients use the internet to research the procedure they will be having and
      given the increasing popularity of YouTube we suspect many patients are using YouTube or
      similar sites as a source of information prior to elective surgery. There are likely a number
      of patient factors that contribute to patients seeking out videos as a source of
      pre-operative medical information. Patient age, which is generally inversely correlated to
      computer literacy, may have a role. Patient anxiety and pre-operative worrying may cause a
      patient to turn to the internet to search for information, and the poor overall quality of
      the content available may worsen pre-operative anxiety.

      The primary objective of this study is to determine if providing patients with a reliable,
      high-quality video about their condition and operation prior to surgery reduces pre-operative
      anxiety. Secondary aims are to determine the percentage of patients that independently seek
      out videos online as a source of medical information prior to elective hand surgery, identify
      patient attributes that are associated with this behavior, and understand if introducing high
      quality pre-surgical videos has an impact on post-operative patient outcomes and/or patient
      engagement. The investigators hypothesize that providing patients with high-quality
      pre-operative videos will reduce pre-operative anxiety. Its is also expected that patients
      who seek out videos on their own for pre-operative medical information will be younger and
      have higher anxiety levels and pain catastrophizing scores. Additionally, the investigators
      hypothesize that patients who watch high-quality pre-operative videos may have better short
      term post-operative outcomes and greater engagement in their care than their counterparts
      that did not watch videos or who sought out videos on their own.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Parallel, 2 groups, 1:1 randomization
primary purpose: Prevention
masking: None (Open Label)
measure: Pre-operative anxiety
time frame: Immediately prior to surgery
description: We will measure pre-operative anxiety using the State-Trait Anxiety Inventory (STAI) 6-item short form (minimum score: 20, maximum score: 80, higher scores indicate more anxiety)
measure: Percentage of patients who sought out pre-operative videos before surgery
time frame: Immediately before surgery
description: We plan to determine the percentage of patients who sought out pre-operative videos before surgery on websites such as YouTube as a part of our "video questionnaire"
measure: Pain catastrophizing
time frame: Immediately before surgery
description: As determined by the pain catastrophizing scale (PCS); (minimum score: 0, maximum score: 100, higher scores indicate more anxiety)
measure: Patient engagement
time frame: Immediately before surgery
description: To determine patient levels of engagement in their care as assessed by the Patient Activation Measure (PAM)-13 (minimum score: 0, maximum score: 100, higher scores indicate higher levels of activation/engagement in care)
measure: Pain scores
time frame: At 48-72 hour post-operatively and 2 weeks post-operatively
description: Assessed by Visual Analog Scale (VAS) pain scores (minimum: 0, maximum: 10, higher scores indicate greater levels of pain)
measure: Functional outcomes
time frame: At 48-72 hour post-operatively and 2 weeks post-operatively
description: Assessed by the Quick Disabilities of the Arm, Shoulder and Hand (qDASH) questionnaire (minimum: 0, maximum: 100, greater scores indicate a greater level of disability)
arm group label: Video group
arm group type: Experimental
description: Patients selected to be in the intervention group will be asked to watch a high-quality, physician created video describing their condition and the operative treatment they are about to undergo.
arm group label: Control group
arm group type: Placebo Comparator
description: Patients selected to be in the control group will not be asked to watch a video prior to surgery.
intervention type: Other
intervention name: High-quality, physician created video
description: The intervention group will watch a short (2-5 minute) video prior to surgery that will provide them with information about their condition and the procedure they are about to undergo (either carpal tunnel release or trigger finger release).
arm group label: Video group
intervention type: Other
intervention name: Standard of care
description: Patients in the control group will not be asked to do anything differently prior to their surgery
arm group label: Control group
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: Northwell Health
investigator full name: Christopher Larsen
investigator title: Physician, Department of Orthopaedic Surgery
mesh term: Trigger Finger Disorder
mesh term: Carpal Tunnel Syndrome
mesh term: Anxiety Disorders
sharing ipd: No