<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/NCT03017027</url>
  </required_header>
  <id_info>
    <org_study_id>HSC-SN-14-0202</org_study_id>
    <nct_id>NCT03017027</nct_id>
  </id_info>
  <brief_title>Effects of Animal Assisted Activity on Biobehavioral Stress Responses of Hospitalized Children: A Randomized Control Trial</brief_title>
  <official_title>Effects of Animal Assisted Activity on Biobehavioral Stress Responses of Hospitalized Children: A Randomized Control Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Texas Health Science Center, Houston</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Texas Health Science Center, Houston</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the efficacy of a 10-minute therapy dog visitation&#xD;
      (TDV) in reducing biobehavioral stress responses among hospitalized school-age children by&#xD;
      comparing responses between TDV and non-TDV control groups.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2015</start_date>
  <completion_date type="Actual">January 2016</completion_date>
  <primary_completion_date type="Actual">January 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>Change in Anxiety as measured by the State Anxiety Inventory for Children (STAI-C) scale</measure>
    <time_frame>immediately before session, immediately after session</time_frame>
    <description>State anxiety will be measured using the State Anxiety Inventory for Children (STAI-C), a widely used instrument with upper elementary or junior high school aged children. The instrument is composed of 20 statements that ask about how one feels at a particular moment in time with three responses from &quot;very to not&quot;. Scores range from 20 to 80 and higher scores indicate a higher state of anxiety. Internal consistency has been demonstrated; researchers have reported acceptable reliability coefficients in hospitalized children ages 7-11 years old with Cronbach's α of .94.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Positive Mood/Affect as measured by the 10-item Positive and Negative Affect Schedule for Children (10 PANAS-C)</measure>
    <time_frame>immediately before session, immediately after session</time_frame>
    <description>The 10 PANAS-C is a 10 item youth self-report measure used in child and adolescent populations which asks youth to rate adjectives of varying mood states (5 negative and 5 positive affect adjectives) on how often they feel joyful, cheerful, happy, lively, and proud and miserable, mad, afraid, scared, and sad. The item responses use a 5-point Likert scale ranging from 1 (&quot;very slightly or none at all&quot;) to 5 (&quot;extremely&quot;). The 10 item PANAS-C demonstrates acceptable validity and internal consistency estimates when compared to the full-length 27-item PANAS-C scale with alpha of .86 for the positive scale; .82 for the negative scale.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Negative Mood/Affect as measured by the 10-item Positive and Negative Affect Schedule for Children (10 PANAS-C)</measure>
    <time_frame>immediately before session, immediately after session</time_frame>
    <description>The 10 PANAS-C is a 10 item youth self-report measure used in child and adolescent populations which asks youth to rate adjectives of varying mood states (5 negative and 5 positive affect adjectives) on how often they feel joyful, cheerful, happy, lively, and proud and miserable, mad, afraid, scared, and sad. The item responses use a 5-point Likert scale ranging from 1 (&quot;very slightly or none at all&quot;) to 5 (&quot;extremely&quot;). The 10 item PANAS-C demonstrates acceptable validity and internal consistency estimates when compared to the full-length 27-item PANAS-C scale with alpha of .86 for the positive scale; .82 for the negative scale.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in biological stress response as assessed by salivary cortisol levels</measure>
    <time_frame>immediately before session, immediately after session</time_frame>
    <description>Saliva samples will be collected salivary cortisol (stress), CRP, and IL-1ß (inflammatory). Time of salivary collection will be between the times of 1000-1300 to control for circadian rhythmicity. On the day of batch assay all samples will be assayed using the Salimetrics ® kits (with acceptable precision and accuracy) with an enzyme immunoassay procedure following the manufacturer's directions.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in biological inflammatory stress responses as assessed by salivary C-reactive protein (CRP) levels</measure>
    <time_frame>immediately before session, immediately after session</time_frame>
    <description>Saliva samples will be collected salivary cortisol (stress), CRP, and IL-1ß (inflammatory). Time of salivary collection will be between the times of 1000-1300 to control for circadian rhythmicity. On the day of batch assay all samples will be assayed using the Salimetrics ® kits (with acceptable precision and accuracy) with an enzyme immunoassay procedure following the manufacturer's directions.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in biological inflammatory stress responses as assessed by salivary interleukin-1beta (IL-1β) levels</measure>
    <time_frame>immediately before session, immediately after session</time_frame>
    <description>Saliva samples will be collected salivary cortisol (stress), CRP, and IL-1ß (inflammatory). Time of salivary collection will be between the times of 1000-1300 to control for circadian rhythmicity. On the day of batch assay all samples will be assayed using the Salimetrics ® kits (with acceptable precision and accuracy) with an enzyme immunoassay procedure following the manufacturer's directions.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Attachment level to pets as assessed by the Pet Attitude Scale (PAS)</measure>
    <time_frame>immediately before session</time_frame>
    <description>Attachment to pets will be measured using the Pet Attitude Scale (PAS)Questionnaire.The PAS is an 18 item paper and pencil instrument with 7 Likert response statements which measures the favorableness of attitudes towards pets. Higher scores indicate more positive attitudes towards pets. Evidence of PAS-M is demonstrated with a Cronbach's alpha of .93.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Human-Animal Interaction as assessed by the Human-Animal Interaction Scale (HAIS)</measure>
    <time_frame>immediately after session</time_frame>
    <description>The Human-Animal Interaction Scale (HAIS) is a newly developed questionnaire designed to measure behavioral interactions between animal and human which predict beneficial effects to humans (Fournier, Letson, Laitalia, &amp; Krog, 2015). The HAIS is a 26 item Likert Scale with 5 Likert response statements ranging from &quot;not at all&quot; to &quot;a great deal&quot; and is completed by the participant after the TDV.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Human-Animal Interaction as assessed by the HAIS observer questionnaire</measure>
    <time_frame>immediately after session</time_frame>
    <description>The HAIS observer questionnaire is a 24 item instrument completed by the research staff who quantifies behaviors with a percent or range in respect to the behavior observed.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">53</enrollment>
  <condition>Psychosocial Stress</condition>
  <arm_group>
    <arm_group_label>Therapy dog visitation (TDV)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The TDV intervention consists of a one-time 10 minute TDV with the dog handler and his/her dog interacting with the patient. The therapy dog visitation program is a currently established program and each therapy dog meets obedience, temperament, and health standards required by the organization and are deemed appropriate to therapy dog visitation. For hygienic reasons, dogs are bathed before visitation and the patient is required to wash hands before and after the visit. The TDV will be casual and not restrict the handler with conversing, which is standard practice in TDV. The therapy dog will be leashed and controlled by the dog handler. If the participant wants the dog to be placed on the bed, a clean sheet will be placed on the bed in between the dog and patient. The TDV will be casual and not restrict the handler with conversing, which is standard practice in TDV. Tactile and visual contact with the dog will be promoted.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>non-TDV control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants randomized to the control condition will receive a new plush stuffed animal for the same 10-min timeframe without any structured activities. At the end of the session, a stuffed animal will be offered to the participant to keep.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Therapy dog visitation (TDV)</intervention_name>
    <description>The TDV intervention consists of a one-time 10 minute TDV with the dog handler and his/her dog interacting with the patient. The therapy dog visitation program is a currently established program and each therapy dog meets obedience, temperament, and health standards required by the organization and are deemed appropriate to therapy dog visitation. For hygienic reasons, dogs are bathed before visitation and the patient is required to wash hands before and after the visit. The TDV will be casual and not restrict the handler with conversing, which is standard practice in TDV. The therapy dog will be leashed and controlled by the dog handler. If the participant wants the dog to be placed on the bed, a clean sheet will be placed on the bed in between the dog and patient. The TDV will be casual and not restrict the handler with conversing, which is standard practice in TDV. Tactile and visual contact with the dog will be promoted.</description>
    <arm_group_label>Therapy dog visitation (TDV)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>non-TDV control</intervention_name>
    <description>Participants randomized to the control condition will receive a new plush stuffed animal for the same 10-min timeframe without any structured activities. At the end of the session, a stuffed animal will be offered to the participant to keep.</description>
    <arm_group_label>non-TDV control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  understand English&#xD;
&#xD;
          -  alert and oriented to person, place, and time&#xD;
&#xD;
          -  able to complete study instruments&#xD;
&#xD;
          -  able to provide saliva specimens, and&#xD;
&#xD;
          -  consent from parent/legal guardian, and&#xD;
&#xD;
          -  assent from child.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  currently taking hormone replacement, or steroidal antiinflammatory medications&#xD;
&#xD;
          -  in contact precautions at facility&#xD;
&#xD;
          -  diagnosed with Addison's or Cushing's disease, and&#xD;
&#xD;
          -  fears, phobias, or allergies to dogs.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sandra M Branson, PhD, MSN, RN</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Texas Health Science Center, Houston</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The University of Texas Health Science Center at Houston</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 9, 2017</study_first_submitted>
  <study_first_submitted_qc>January 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <last_update_submitted>January 9, 2017</last_update_submitted>
  <last_update_submitted_qc>January 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Texas Health Science Center, Houston</investigator_affiliation>
    <investigator_full_name>Sandra M Branson</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>human-animal interaction</keyword>
  <!-- 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/NCT03017027
org study id: HSC-SN-14-0202
nct id: NCT03017027
lead sponsor: 
has dmc: No
The purpose of this study is to assess the efficacy of a 10-minute therapy dog visitation
      (TDV) in reducing biobehavioral stress responses among hospitalized school-age children by
      comparing responses between TDV and non-TDV control groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Anxiety as measured by the State Anxiety Inventory for Children (STAI-C) scale
time frame: immediately before session, immediately after session
description: State anxiety will be measured using the State Anxiety Inventory for Children (STAI-C), a widely used instrument with upper elementary or junior high school aged children. The instrument is composed of 20 statements that ask about how one feels at a particular moment in time with three responses from "very to not". Scores range from 20 to 80 and higher scores indicate a higher state of anxiety. Internal consistency has been demonstrated; researchers have reported acceptable reliability coefficients in hospitalized children ages 7-11 years old with Cronbach's α of .94.
measure: Change in Positive Mood/Affect as measured by the 10-item Positive and Negative Affect Schedule for Children (10 PANAS-C)
time frame: immediately before session, immediately after session
description: The 10 PANAS-C is a 10 item youth self-report measure used in child and adolescent populations which asks youth to rate adjectives of varying mood states (5 negative and 5 positive affect adjectives) on how often they feel joyful, cheerful, happy, lively, and proud and miserable, mad, afraid, scared, and sad. The item responses use a 5-point Likert scale ranging from 1 ("very slightly or none at all") to 5 ("extremely"). The 10 item PANAS-C demonstrates acceptable validity and internal consistency estimates when compared to the full-length 27-item PANAS-C scale with alpha of .86 for the positive scale; .82 for the negative scale.
measure: Change in Negative Mood/Affect as measured by the 10-item Positive and Negative Affect Schedule for Children (10 PANAS-C)
time frame: immediately before session, immediately after session
description: The 10 PANAS-C is a 10 item youth self-report measure used in child and adolescent populations which asks youth to rate adjectives of varying mood states (5 negative and 5 positive affect adjectives) on how often they feel joyful, cheerful, happy, lively, and proud and miserable, mad, afraid, scared, and sad. The item responses use a 5-point Likert scale ranging from 1 ("very slightly or none at all") to 5 ("extremely"). The 10 item PANAS-C demonstrates acceptable validity and internal consistency estimates when compared to the full-length 27-item PANAS-C scale with alpha of .86 for the positive scale; .82 for the negative scale.
measure: Change in biological stress response as assessed by salivary cortisol levels
time frame: immediately before session, immediately after session
description: Saliva samples will be collected salivary cortisol (stress), CRP, and IL-1ß (inflammatory). Time of salivary collection will be between the times of 1000-1300 to control for circadian rhythmicity. On the day of batch assay all samples will be assayed using the Salimetrics ® kits (with acceptable precision and accuracy) with an enzyme immunoassay procedure following the manufacturer's directions.
measure: Change in biological inflammatory stress responses as assessed by salivary C-reactive protein (CRP) levels
time frame: immediately before session, immediately after session
description: Saliva samples will be collected salivary cortisol (stress), CRP, and IL-1ß (inflammatory). Time of salivary collection will be between the times of 1000-1300 to control for circadian rhythmicity. On the day of batch assay all samples will be assayed using the Salimetrics ® kits (with acceptable precision and accuracy) with an enzyme immunoassay procedure following the manufacturer's directions.
measure: Change in biological inflammatory stress responses as assessed by salivary interleukin-1beta (IL-1β) levels
time frame: immediately before session, immediately after session
description: Saliva samples will be collected salivary cortisol (stress), CRP, and IL-1ß (inflammatory). Time of salivary collection will be between the times of 1000-1300 to control for circadian rhythmicity. On the day of batch assay all samples will be assayed using the Salimetrics ® kits (with acceptable precision and accuracy) with an enzyme immunoassay procedure following the manufacturer's directions.
measure: Attachment level to pets as assessed by the Pet Attitude Scale (PAS)
time frame: immediately before session
description: Attachment to pets will be measured using the Pet Attitude Scale (PAS)Questionnaire.The PAS is an 18 item paper and pencil instrument with 7 Likert response statements which measures the favorableness of attitudes towards pets. Higher scores indicate more positive attitudes towards pets. Evidence of PAS-M is demonstrated with a Cronbach's alpha of .93.
measure: Human-Animal Interaction as assessed by the Human-Animal Interaction Scale (HAIS)
time frame: immediately after session
description: The Human-Animal Interaction Scale (HAIS) is a newly developed questionnaire designed to measure behavioral interactions between animal and human which predict beneficial effects to humans (Fournier, Letson, Laitalia, & Krog, 2015). The HAIS is a 26 item Likert Scale with 5 Likert response statements ranging from "not at all" to "a great deal" and is completed by the participant after the TDV.
measure: Human-Animal Interaction as assessed by the HAIS observer questionnaire
time frame: immediately after session
description: The HAIS observer questionnaire is a 24 item instrument completed by the research staff who quantifies behaviors with a percent or range in respect to the behavior observed.
arm group label: Therapy dog visitation (TDV)
arm group type: Experimental
description: The TDV intervention consists of a one-time 10 minute TDV with the dog handler and his/her dog interacting with the patient. The therapy dog visitation program is a currently established program and each therapy dog meets obedience, temperament, and health standards required by the organization and are deemed appropriate to therapy dog visitation. For hygienic reasons, dogs are bathed before visitation and the patient is required to wash hands before and after the visit. The TDV will be casual and not restrict the handler with conversing, which is standard practice in TDV. The therapy dog will be leashed and controlled by the dog handler. If the participant wants the dog to be placed on the bed, a clean sheet will be placed on the bed in between the dog and patient. The TDV will be casual and not restrict the handler with conversing, which is standard practice in TDV. Tactile and visual contact with the dog will be promoted.
arm group label: non-TDV control
arm group type: Other
description: Participants randomized to the control condition will receive a new plush stuffed animal for the same 10-min timeframe without any structured activities. At the end of the session, a stuffed animal will be offered to the participant to keep.
intervention type: Behavioral
intervention name: Therapy dog visitation (TDV)
description: The TDV intervention consists of a one-time 10 minute TDV with the dog handler and his/her dog interacting with the patient. The therapy dog visitation program is a currently established program and each therapy dog meets obedience, temperament, and health standards required by the organization and are deemed appropriate to therapy dog visitation. For hygienic reasons, dogs are bathed before visitation and the patient is required to wash hands before and after the visit. The TDV will be casual and not restrict the handler with conversing, which is standard practice in TDV. The therapy dog will be leashed and controlled by the dog handler. If the participant wants the dog to be placed on the bed, a clean sheet will be placed on the bed in between the dog and patient. The TDV will be casual and not restrict the handler with conversing, which is standard practice in TDV. Tactile and visual contact with the dog will be promoted.
arm group label: Therapy dog visitation (TDV)
intervention type: Behavioral
intervention name: non-TDV control
description: Participants randomized to the control condition will receive a new plush stuffed animal for the same 10-min timeframe without any structured activities. At the end of the session, a stuffed animal will be offered to the participant to keep.
arm group label: non-TDV control
criteria: 
gender: All
minimum age: 7 Years
maximum age: 17 Years
healthy volunteers: No
last name: Sandra M Branson, PhD, MSN, RN
role: Principal Investigator
affiliation: The University of Texas Health Science Center, Houston
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: The University of Texas Health Science Center, Houston
investigator full name: Sandra M Branson
investigator title: Assistant Professor