<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/NCT04503382</url>
  </required_header>
  <id_info>
    <org_study_id>EK-002</org_study_id>
    <nct_id>NCT04503382</nct_id>
  </id_info>
  <brief_title>Impact of Kindness Videos in Health Care Settings</brief_title>
  <official_title>An Exploratory Study of the Impact of Kindness Videos in Health Care Settings</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Envision Kindness Inc</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Penn State University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Envision Kindness Inc</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 study builds on earlier work assessing the impact of kindness media on viewers'&#xD;
      emotional responses. Using images of kindness and connection, as well as other content, we&#xD;
      will test its impact on emotions and behavior in the field. The setting is in healthcare,&#xD;
      specifically a pediatric dental clinic. Using simple scales, participants anonymously rate&#xD;
      themselves on a variety of emotions, watch a television for 8 minutes, and then complete the&#xD;
      self-assessment. An honorarium is provided for participation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The present study builds on the earlier work with a focused application of inspiring content&#xD;
      in health care settings. It is well described that health care providers, including doctors,&#xD;
      nurses, and other staff members) have high rates of burnout, depression, and&#xD;
      suicide-approximately twice that of the general population. In addition to the lower quality&#xD;
      of life for the individual health care provider, this burnout problem has consequences for&#xD;
      the patient, including heightened number of medical errors.&#xD;
&#xD;
      Patients, of course, also have significant stressors in their lives. Perhaps, those center on&#xD;
      health-related issues, or are more general in nature. In the general population, it is known&#xD;
      that anxiety, perceived stress, opiate abuse, and suicide are all rising.&#xD;
&#xD;
      From the patients' perspective, it is important to encourage them to adapt behaviors and&#xD;
      attitudes that will benefit themselves as well as others. It has been shown that being kind&#xD;
      and compassionate can yield positive impacts on health: people who volunteer regularly, for&#xD;
      example, have death rates 20-40% lower than those who do not. Another facet of inducing&#xD;
      kindness and compassion is kindness towards oneself. In health care settings, behavioral&#xD;
      modification is very challenging. One way to rethink that approach is teaching and&#xD;
      illustrating to patients how kindness to oneself is a necessity. Kindness to oneself&#xD;
      encompasses following physician instructions as well as general health practice. By providing&#xD;
      inspiring visual content to both patients and providers, it is believed that at least&#xD;
      additive if not synergistic interaction will occur with simultaneous promotion of kindness,&#xD;
      compassion, joy and love for both groups.&#xD;
&#xD;
      To date, multiple publications have pointed to the observation that various types of media&#xD;
      can inspire viewers such that they are &quot;moved&quot; or &quot;touched&quot; or &quot;elevated.&quot; Most of these&#xD;
      studies have focused on the use of single films from several minutes long to full length&#xD;
      feature films.&#xD;
&#xD;
      Much of the above cited research has been done in a laboratory or structured research&#xD;
      setting. While very valuable, this research plan focuses on a &quot;real world&quot; setting, i.e.,&#xD;
      with patients and practitioners at the source in their work environments. The first step is&#xD;
      to measure responses from both providers and patients.&#xD;
&#xD;
      C. Objectives&#xD;
&#xD;
        1. Quantify the response to videos depicting kindness, compassion, connection, joy, and&#xD;
           love for both patients (or caregivers) and for health care staff.&#xD;
&#xD;
        2. Compare these responses to the standard content that the site uses.&#xD;
&#xD;
        3. Determine the impact of these videos on a measure of generosity.&#xD;
&#xD;
        4. Obtain qualitative feedback on the content in the effort to improve the content.&#xD;
&#xD;
      D. Hypothesis&#xD;
&#xD;
        1. Kindness media both moves and provides a significant lift in emotional state for both&#xD;
           sets of viewers (providers and patients).&#xD;
&#xD;
        2. Compared to what is usually shown, kindness media has significant impact on emotional&#xD;
           state.&#xD;
&#xD;
        3. Viewers will prefer to see more kindness media upon future visits.&#xD;
&#xD;
      Design:&#xD;
&#xD;
      Open, randomized, comparator-controlled study of kindness media versus commercial media on&#xD;
      emotions and behavior. Parents and staff of the clinic are recruited as participants. Surveys&#xD;
      with self-ratings are completed before and then after watching either kindness media or&#xD;
      commercial (standard) children's media for 8 minutes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2019</start_date>
  <completion_date type="Actual">September 30, 2020</completion_date>
  <primary_completion_date type="Actual">July 15, 2020</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>Emotional responses</measure>
    <time_frame>immediately after intervention</time_frame>
    <description>Set of questions regarding self-assessed emotional states including happiness, feeling calm, grateful, compassionate, optimistic, sad, irritated, or anxious. Scored 1-5 with &quot;1&quot; = not at all and &quot;5&quot;= a lot.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants who donated</measure>
    <time_frame>Immediately after intervention</time_frame>
    <description>Measurement of donation--participants are asked whether or not they would be willing to donate to a family in need. The number of donations in each intervention group is counted.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">53</enrollment>
  <condition>Altruism</condition>
  <condition>Behavior</condition>
  <condition>Emotions</condition>
  <arm_group>
    <arm_group_label>Kindness media</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Short videos of kindness media. As part of a program entitled EnSpire®, this media consists of short videos that display acts of kindness and compassion that are edited together into a single reel.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard television</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Children's commercial programming--as the control condition, participants watched commercial children's programming such as Disney, Nickelodeon, etc.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Kindness Media</intervention_name>
    <description>As described above, the intervention is a series of short videos that display acts of kindness or ideas about kindness. These videos are edited together into one reel that was 8 minutes long.</description>
    <arm_group_label>Kindness media</arm_group_label>
    <arm_group_label>Standard television</arm_group_label>
    <other_name>EnSpire®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Ability to give consent and complete forms&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Children Dental Associates of New London County</name>
      <address>
        <city>New London</city>
        <state>Connecticut</state>
        <zip>06333</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>March 21, 2022</last_update_submitted>
  <last_update_submitted_qc>March 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>kindness</keyword>
  <keyword>behavior</keyword>
  <keyword>altruism</keyword>
  <keyword>emotions</keyword>
  <keyword>generosity</keyword>
  <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/NCT04503382
org study id: EK-002
nct id: NCT04503382
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study builds on earlier work assessing the impact of kindness media on viewers'
      emotional responses. Using images of kindness and connection, as well as other content, we
      will test its impact on emotions and behavior in the field. The setting is in healthcare,
      specifically a pediatric dental clinic. Using simple scales, participants anonymously rate
      themselves on a variety of emotions, watch a television for 8 minutes, and then complete the
      self-assessment. An honorarium is provided for participation.
The present study builds on the earlier work with a focused application of inspiring content
      in health care settings. It is well described that health care providers, including doctors,
      nurses, and other staff members) have high rates of burnout, depression, and
      suicide-approximately twice that of the general population. In addition to the lower quality
      of life for the individual health care provider, this burnout problem has consequences for
      the patient, including heightened number of medical errors.

      Patients, of course, also have significant stressors in their lives. Perhaps, those center on
      health-related issues, or are more general in nature. In the general population, it is known
      that anxiety, perceived stress, opiate abuse, and suicide are all rising.

      From the patients' perspective, it is important to encourage them to adapt behaviors and
      attitudes that will benefit themselves as well as others. It has been shown that being kind
      and compassionate can yield positive impacts on health: people who volunteer regularly, for
      example, have death rates 20-40% lower than those who do not. Another facet of inducing
      kindness and compassion is kindness towards oneself. In health care settings, behavioral
      modification is very challenging. One way to rethink that approach is teaching and
      illustrating to patients how kindness to oneself is a necessity. Kindness to oneself
      encompasses following physician instructions as well as general health practice. By providing
      inspiring visual content to both patients and providers, it is believed that at least
      additive if not synergistic interaction will occur with simultaneous promotion of kindness,
      compassion, joy and love for both groups.

      To date, multiple publications have pointed to the observation that various types of media
      can inspire viewers such that they are "moved" or "touched" or "elevated." Most of these
      studies have focused on the use of single films from several minutes long to full length
      feature films.

      Much of the above cited research has been done in a laboratory or structured research
      setting. While very valuable, this research plan focuses on a "real world" setting, i.e.,
      with patients and practitioners at the source in their work environments. The first step is
      to measure responses from both providers and patients.

      C. Objectives

        1. Quantify the response to videos depicting kindness, compassion, connection, joy, and
           love for both patients (or caregivers) and for health care staff.

        2. Compare these responses to the standard content that the site uses.

        3. Determine the impact of these videos on a measure of generosity.

        4. Obtain qualitative feedback on the content in the effort to improve the content.

      D. Hypothesis

        1. Kindness media both moves and provides a significant lift in emotional state for both
           sets of viewers (providers and patients).

        2. Compared to what is usually shown, kindness media has significant impact on emotional
           state.

        3. Viewers will prefer to see more kindness media upon future visits.

      Design:

      Open, randomized, comparator-controlled study of kindness media versus commercial media on
      emotions and behavior. Parents and staff of the clinic are recruited as participants. Surveys
      with self-ratings are completed before and then after watching either kindness media or
      commercial (standard) children's media for 8 minutes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Emotional responses
time frame: immediately after intervention
description: Set of questions regarding self-assessed emotional states including happiness, feeling calm, grateful, compassionate, optimistic, sad, irritated, or anxious. Scored 1-5 with "1" = not at all and "5"= a lot.
measure: Number of participants who donated
time frame: Immediately after intervention
description: Measurement of donation--participants are asked whether or not they would be willing to donate to a family in need. The number of donations in each intervention group is counted.
arm group label: Kindness media
arm group type: Experimental
description: Short videos of kindness media. As part of a program entitled EnSpire®, this media consists of short videos that display acts of kindness and compassion that are edited together into a single reel.
arm group label: Standard television
arm group type: Active Comparator
description: Children's commercial programming--as the control condition, participants watched commercial children's programming such as Disney, Nickelodeon, etc.
intervention type: Other
intervention name: Kindness Media
description: As described above, the intervention is a series of short videos that display acts of kindness or ideas about kindness. These videos are edited together into one reel that was 8 minutes long.
arm group label: Kindness media
arm group label: Standard television
other name: EnSpire®
criteria: 
gender: All
gender based: Yes
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No