xml: <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/NCT06020677</url>
    </required_header>
    <id_info>
      <org_study_id>R61MH132249</org_study_id>
      <nct_id>NCT06020677</nct_id>
    </id_info>
    <brief_title>Latinx Children and Surgery</brief_title>
    <official_title>Latinx Children and Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of California, Irvine</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of California, Irvine</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Over 60 million persons in the United States (US) identify themselves as Latinx and 25.6% are&#xD;
        children under the age of 16.&#xD;
  &#xD;
        Surgical disparities for adults and children have been identified as a major problem in the&#xD;
        US and can be experienced at multiple points along a patient's health care trajectory. Data&#xD;
        from the investigator's center indicates that a substantial portion of Latinx children who&#xD;
        undergo surgery experience high anxiety and postoperative pain as well as postoperative&#xD;
        impairments in psychological and physical functioning as compared to White non-Latin children&#xD;
        who undergo surgery. Recent growth in use of mobile devices provides us an opportunity to&#xD;
        create low-cost mobile health (mHealth) behavioral interventions to reduce this disparity in&#xD;
        surgical outcomes.&#xD;
  &#xD;
        In a previous National Institutes of Health (NIH) award, the principal investigator (PI)&#xD;
        developed and tested an evidence based mHealth tailored intervention (WebTIPS) that aims to&#xD;
        prepare and be a companion of a child and their family during a surgical event. WebTIPS aims&#xD;
        to enhance the recovery of the child in several ways such as reducing anxiety and pain and is&#xD;
        based on information provision, modeling, and teaching of coping skills. WebTIPS, however,&#xD;
        was developed and validated with a population of primarily White non-Latinx English-speaking&#xD;
        children and their parents. Unfortunately, it is well established that mHealth interventions&#xD;
        are significantly less effective when used with specific ethnic minorities unless they&#xD;
        underwent a process of cultural adaptation. Over the past 4-years, the investigators have&#xD;
        established multiple academic and community collaborations, conducted extensive participatory&#xD;
        research with Latinx stakeholders and used the heuristic framework and a modified ecological&#xD;
        validity model to culturally adapt WebTIPS. The culturally adapted intervention is called&#xD;
        L-WebTIPS. The overall aim of this application is to reduce surgical disparities in a&#xD;
        population of Latinx children undergoing surgery. The first phase of this application (R61)&#xD;
        includes web programming of L-WebTIPS, conduct formative evaluation and conduct feasibly&#xD;
        randomized control trial (RCT) to test this intervention. The second phase (R33) includes a&#xD;
        multi-center RCT which aims to determine the effectiveness of L-WebTIPS compared to attention&#xD;
        control intervention in decreasing postoperative pain, opioids consumption and lowering&#xD;
        anxiety in Latinx children undergoing outpatient surgery. Secondary aims of the R33 include&#xD;
        examining the impact of L-WebTIPS on home-based clinical recovery parameters such as pain,&#xD;
        analgesic requirements, new onset behavioral changes and return to normal daily activity in&#xD;
        Latinx children undergoing outpatient surgery. The investigators also plan to determine if&#xD;
        the use of L-WebTIPS reduces anxiety and improve experience among the parents of Latinx&#xD;
        children undergoing surgery.&#xD;
  &#xD;
        Finally, the investigators plan to determine if the use of L-WebTIPS reduces anxiety and&#xD;
        enhance experience among the parents of Latinx children undergoing surgery. The investigators&#xD;
        submit that using a cultural adaption process for an existing validated intervention will&#xD;
        accelerate the process of reducing surgical disparities and bringing an effective&#xD;
        intervention to clinical settings and routine use.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">September 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 31, 2024</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>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Child Anxiety</measure>
      <time_frame>Child anxiety before surgery, while in the holding area.</time_frame>
      <description>Child anxiety is assessed using the Modified Yale Preoperative Anxiety Scale (mYPAS) in four time points: the holding area, separation, entrance to the operating room, and the placement of the anesthesia mask. The mYPAS is an observational measure of preoperative anxiety in children consisting of 27 items in five domains of behavior indicating anxiety in young children (Activity, Emotional expressivity, State of arousal, Vocalization and Use of parents). For each category the child is scored from 1-4 (however in vocalization it is 1-6). The mYPAS total score is a sum of all categories for all time points, and ranges from 0 to 100 with higher scores indicating greater anxiety.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Child Anxiety</measure>
      <time_frame>Child anxiety when exiting the holding room and up to the point when the child reaches the operating room (OR) doors.</time_frame>
      <description>Child anxiety is assessed using the Modified Yale Preoperative Anxiety Scale (mYPAS) in four time points: the holding area, separation, entrance to the operating room, and the placement of the anesthesia mask. The mYPAS is an observational measure of preoperative anxiety in children consisting of 27 items in five domains of behavior indicating anxiety in young children (Activity, Emotional expressivity, State of arousal, Vocalization and Use of parents). For each category the child is scored from 1-4 (however in vocalization it is 1-6). The mYPAS total score is a sum of all categories for all time points, and ranges from 0 to 100 with higher scores indicating greater anxiety.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Child Anxiety</measure>
      <time_frame>Child anxiety when child walks into the OR and ends when they are presented with and visually aware of the induction mask.</time_frame>
      <description>Child anxiety is assessed using the Modified Yale Preoperative Anxiety Scale (mYPAS) in four time points: the holding area, separation, entrance to the operating room, and the placement of the anesthesia mask. The mYPAS is an observational measure of preoperative anxiety in children consisting of 27 items in five domains of behavior indicating anxiety in young children (Activity, Emotional expressivity, State of arousal, Vocalization and Use of parents). For each category the child is scored from 1-4 (however in vocalization it is 1-6). The mYPAS total score is a sum of all categories for all time points, and ranges from 0 to 100 with higher scores indicating greater anxiety.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Child Anxiety</measure>
      <time_frame>Child anxiety when the child becomes aware of the mask and ends when they are asleep.</time_frame>
      <description>Child anxiety is assessed using the Modified Yale Preoperative Anxiety Scale (mYPAS) in four time points: the holding area, separation, entrance to the operating room, and the placement of the anesthesia mask. The mYPAS is an observational measure of preoperative anxiety in children consisting of 27 items in five domains of behavior indicating anxiety in young children (Activity, Emotional expressivity, State of arousal, Vocalization and Use of parents). For each category the child is scored from 1-4 (however in vocalization it is 1-6). The mYPAS total score is a sum of all categories for all time points, and ranges from 0 to 100 with higher scores indicating greater anxiety.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Assess Pediatric Anesthesia Emergence Delirium [Emergence status and Psychometric Evaluation in children]</measure>
      <time_frame>Post surgery while in the post anesthesia care unit</time_frame>
      <description>Emergence status will be assessed through the Pediatric Anesthesia Emergence Delirium Scale (PAED). Items rated on a 5-point rating scale from 0 (&quot;extremely&quot;) to 4 (&quot;not at all&quot;). The PAED rating scale consists of five psychometric items (&quot;child makes eye contact with the caregiver&quot;, &quot;child's actions are purposeful,&quot; &quot;child is aware of the surroundings,&quot; &quot;child is restless,&quot; &quot;child is inconsolable&quot;) for the measurement of Emergence Delirium in children. Items are summed up for a total score that directly increases with the degree of emergence delirium.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in children's pain intensity using the Postoperative Pain Measure (PPPM)</measure>
      <time_frame>Days 1-14 after surgery, once a day</time_frame>
      <description>Postoperative pain intensity will be assessed through the 15-item Postoperative Pain Measure (PPPM) in which parents can indicate the presence or absence of each of the 15 behavioral indicators of pain by selecting either &quot;Yes&quot; or &quot;No&quot; for each question. In this scale, &quot;0: Yes&quot; and &quot;1: No.&quot; A total score is achieved by summing all 15 items--higher scores suggest greater pain intensity. The questions on this scale are specific to postoperative pain (e.g. Refuse to eat? Eat less than usual?).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Parental Preoperative Anxiety using the State Trait Anxiety Inventory (STAI-T)</measure>
      <time_frame>Day of surgery</time_frame>
      <description>The Trait section of the questionnaire is administered to parents to assess their self-reported anxiety. Items rated on a 4-point Likert Scale from 1 (&quot;Almost Never&quot;) to 4 (&quot;Almost Always&quot;). The score range is 20-80, the higher score indicating greater anxiety.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Assess parent satisfaction outcomes using the National Research Council (NRC) Picker satisfaction survey</measure>
      <time_frame>Postoperative, day 1</time_frame>
      <description>Parent satisfaction scores will be evaluated through the National Research Council (NRC) Picker satisfaction survey - Outpatient surgery questionnaire. The questions on this survey evaluate satisfaction with the most recent hospital stay (e.g. Did the care providers explain things in a way you could understand?). Each question presents a multiple choice response of either &quot;Yes-definitely, Yes - mostly, Yes-somewhat, and No.&quot; For each question, a higher score indicates greater satisfaction with their visit.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">120</enrollment>
    <condition>Pain, Postoperative</condition>
    <condition>Pain, Acute</condition>
    <arm_group>
      <arm_group_label>L-WebTIPS</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>L-WebINFO</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>L-WebTIPS</intervention_name>
      <description>This mobile health application includes cultural adaption and grounding of a previously developed and tested tailored mHealth intervention, WebTIPS. LWebTIPS is a culturally adapted mHealth intervention that is aimed at the child and parent and strives to improve clinical outcomes and patient experience of Latinx children. Tailoring variables include: Simpatia, Religiosity and Familism.</description>
      <arm_group_label>L-WebTIPS</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Children:&#xD;
  &#xD;
            1. Children age 2-7 who are scheduled to undergo outpatient surgery.&#xD;
  &#xD;
            2. Children of Latinx parents, who speak Spanish as a primary language and who may speak&#xD;
               English&#xD;
  &#xD;
            3. Children whose health status is American Society of Anesthesiologists (ASA) physical&#xD;
               status I-III will be recruited for this study. ASA status I refers to &quot;patients who&#xD;
               are normal and healthy with no known systemic disease&quot;. ASA status II refers to&#xD;
               &quot;patients who have mild or well-controlled systemic diseases,&quot; such as non-insulin&#xD;
               dependent diabetes, upper respiratory conditions, well-controlled asthma or allergies.&#xD;
               ASA status III refers to patients who have moderate or severe systemic disease, which&#xD;
               does limit their activities (e.g., stable angina or diabetes with systemic sequellae).&#xD;
               This criteria was chosen as this group of children will typically undergo surgery in&#xD;
               an outpatient setting. ASA status IV children will most likely undergo surgery in an&#xD;
               inpatient setting and represents a much sicker population of children with different&#xD;
               barriers.&#xD;
  &#xD;
            4. Only children who are in the normal range of development will be recruited for this&#xD;
               study. This will be assessed by report from the parents at the time of recruitment.&#xD;
               The rationale for excluding patients with developmental delay is that it is unknown&#xD;
               whether parents manage their children's postoperative pain differently than in the&#xD;
               general population. To generalize the findings to the general population, children&#xD;
               with developmental delays will be excluded.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Children with health status defined by ASA status IV-V will be excluded from this&#xD;
               study. ASA status IV refers to &quot;patients with an incapacitating systemic disease that&#xD;
               is a constant threat to life&quot;. ASA status V &quot;patients are considered moribund&quot;.&#xD;
  &#xD;
            2. Children whose parents do not identify as Latinx will be excluded from this study.&#xD;
  &#xD;
            3. Children who are taking psychotropic or pain medications that affect emotion&#xD;
               modulation will be excluded from this study because of the potential for confounding&#xD;
               effects on pain.&#xD;
  &#xD;
            4. Children with current malignant or any other disease or pain condition will be&#xD;
               excluded as this may impact postoperative pain and thus be a confounding variable.&#xD;
  &#xD;
          Parent:&#xD;
  &#xD;
          Inclusion Criteria:&#xD;
  &#xD;
          1. Latinx Parents of children who are enrolled in the study who speak Spanish as a primary&#xD;
          language and who may speak English.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Parents who refuse to be part of the study.&#xD;
  &#xD;
            2. Parents who do not speak Spanish as the primary language.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>2 Years</minimum_age>
      <maximum_age>7 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Haydee Cortes, BA</last_name>
      <phone>7144562838</phone>
      <email>cortesh@hs.uci.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Children's Hospital of Orange County</name>
        <address>
          <city>Orange</city>
          <state>California</state>
          <zip>92868</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Haydee Cortes</last_name>
        <phone>818-438-6107</phone>
        <email>cortesh@hs.uci.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>February 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of California, Irvine</investigator_affiliation>
      <investigator_full_name>Zeev Kain</investigator_full_name>
      <investigator_title>Distinguished Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pain, Postoperative</mesh_term>
      <mesh_term>Acute Pain</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06020677
  org study id: R61MH132249
  nct id: NCT06020677
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Over 60 million persons in the United States (US) identify themselves as Latinx and 25.6% are
        children under the age of 16.
  
        Surgical disparities for adults and children have been identified as a major problem in the
        US and can be experienced at multiple points along a patient's health care trajectory. Data
        from the investigator's center indicates that a substantial portion of Latinx children who
        undergo surgery experience high anxiety and postoperative pain as well as postoperative
        impairments in psychological and physical functioning as compared to White non-Latin children
        who undergo surgery. Recent growth in use of mobile devices provides us an opportunity to
        create low-cost mobile health (mHealth) behavioral interventions to reduce this disparity in
        surgical outcomes.
  
        In a previous National Institutes of Health (NIH) award, the principal investigator (PI)
        developed and tested an evidence based mHealth tailored intervention (WebTIPS) that aims to
        prepare and be a companion of a child and their family during a surgical event. WebTIPS aims
        to enhance the recovery of the child in several ways such as reducing anxiety and pain and is
        based on information provision, modeling, and teaching of coping skills. WebTIPS, however,
        was developed and validated with a population of primarily White non-Latinx English-speaking
        children and their parents. Unfortunately, it is well established that mHealth interventions
        are significantly less effective when used with specific ethnic minorities unless they
        underwent a process of cultural adaptation. Over the past 4-years, the investigators have
        established multiple academic and community collaborations, conducted extensive participatory
        research with Latinx stakeholders and used the heuristic framework and a modified ecological
        validity model to culturally adapt WebTIPS. The culturally adapted intervention is called
        L-WebTIPS. The overall aim of this application is to reduce surgical disparities in a
        population of Latinx children undergoing surgery. The first phase of this application (R61)
        includes web programming of L-WebTIPS, conduct formative evaluation and conduct feasibly
        randomized control trial (RCT) to test this intervention. The second phase (R33) includes a
        multi-center RCT which aims to determine the effectiveness of L-WebTIPS compared to attention
        control intervention in decreasing postoperative pain, opioids consumption and lowering
        anxiety in Latinx children undergoing outpatient surgery. Secondary aims of the R33 include
        examining the impact of L-WebTIPS on home-based clinical recovery parameters such as pain,
        analgesic requirements, new onset behavioral changes and return to normal daily activity in
        Latinx children undergoing outpatient surgery. The investigators also plan to determine if
        the use of L-WebTIPS reduces anxiety and improve experience among the parents of Latinx
        children undergoing surgery.
  
        Finally, the investigators plan to determine if the use of L-WebTIPS reduces anxiety and
        enhance experience among the parents of Latinx children undergoing surgery. The investigators
        submit that using a cultural adaption process for an existing validated intervention will
        accelerate the process of reducing surgical disparities and bringing an effective
        intervention to clinical settings and routine use.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Child Anxiety
  time frame: Child anxiety before surgery, while in the holding area.
  description: Child anxiety is assessed using the Modified Yale Preoperative Anxiety Scale (mYPAS) in four time points: the holding area, separation, entrance to the operating room, and the placement of the anesthesia mask. The mYPAS is an observational measure of preoperative anxiety in children consisting of 27 items in five domains of behavior indicating anxiety in young children (Activity, Emotional expressivity, State of arousal, Vocalization and Use of parents). For each category the child is scored from 1-4 (however in vocalization it is 1-6). The mYPAS total score is a sum of all categories for all time points, and ranges from 0 to 100 with higher scores indicating greater anxiety.
  measure: Child Anxiety
  time frame: Child anxiety when exiting the holding room and up to the point when the child reaches the operating room (OR) doors.
  description: Child anxiety is assessed using the Modified Yale Preoperative Anxiety Scale (mYPAS) in four time points: the holding area, separation, entrance to the operating room, and the placement of the anesthesia mask. The mYPAS is an observational measure of preoperative anxiety in children consisting of 27 items in five domains of behavior indicating anxiety in young children (Activity, Emotional expressivity, State of arousal, Vocalization and Use of parents). For each category the child is scored from 1-4 (however in vocalization it is 1-6). The mYPAS total score is a sum of all categories for all time points, and ranges from 0 to 100 with higher scores indicating greater anxiety.
  measure: Child Anxiety
  time frame: Child anxiety when child walks into the OR and ends when they are presented with and visually aware of the induction mask.
  description: Child anxiety is assessed using the Modified Yale Preoperative Anxiety Scale (mYPAS) in four time points: the holding area, separation, entrance to the operating room, and the placement of the anesthesia mask. The mYPAS is an observational measure of preoperative anxiety in children consisting of 27 items in five domains of behavior indicating anxiety in young children (Activity, Emotional expressivity, State of arousal, Vocalization and Use of parents). For each category the child is scored from 1-4 (however in vocalization it is 1-6). The mYPAS total score is a sum of all categories for all time points, and ranges from 0 to 100 with higher scores indicating greater anxiety.
  measure: Child Anxiety
  time frame: Child anxiety when the child becomes aware of the mask and ends when they are asleep.
  description: Child anxiety is assessed using the Modified Yale Preoperative Anxiety Scale (mYPAS) in four time points: the holding area, separation, entrance to the operating room, and the placement of the anesthesia mask. The mYPAS is an observational measure of preoperative anxiety in children consisting of 27 items in five domains of behavior indicating anxiety in young children (Activity, Emotional expressivity, State of arousal, Vocalization and Use of parents). For each category the child is scored from 1-4 (however in vocalization it is 1-6). The mYPAS total score is a sum of all categories for all time points, and ranges from 0 to 100 with higher scores indicating greater anxiety.
  measure: Assess Pediatric Anesthesia Emergence Delirium [Emergence status and Psychometric Evaluation in children]
  time frame: Post surgery while in the post anesthesia care unit
  description: Emergence status will be assessed through the Pediatric Anesthesia Emergence Delirium Scale (PAED). Items rated on a 5-point rating scale from 0 ("extremely") to 4 ("not at all"). The PAED rating scale consists of five psychometric items ("child makes eye contact with the caregiver", "child's actions are purposeful," "child is aware of the surroundings," "child is restless," "child is inconsolable") for the measurement of Emergence Delirium in children. Items are summed up for a total score that directly increases with the degree of emergence delirium.
  measure: Change in children's pain intensity using the Postoperative Pain Measure (PPPM)
  time frame: Days 1-14 after surgery, once a day
  description: Postoperative pain intensity will be assessed through the 15-item Postoperative Pain Measure (PPPM) in which parents can indicate the presence or absence of each of the 15 behavioral indicators of pain by selecting either "Yes" or "No" for each question. In this scale, "0: Yes" and "1: No." A total score is achieved by summing all 15 items--higher scores suggest greater pain intensity. The questions on this scale are specific to postoperative pain (e.g. Refuse to eat? Eat less than usual?).
  measure: Parental Preoperative Anxiety using the State Trait Anxiety Inventory (STAI-T)
  time frame: Day of surgery
  description: The Trait section of the questionnaire is administered to parents to assess their self-reported anxiety. Items rated on a 4-point Likert Scale from 1 ("Almost Never") to 4 ("Almost Always"). The score range is 20-80, the higher score indicating greater anxiety.
  measure: Assess parent satisfaction outcomes using the National Research Council (NRC) Picker satisfaction survey
  time frame: Postoperative, day 1
  description: Parent satisfaction scores will be evaluated through the National Research Council (NRC) Picker satisfaction survey - Outpatient surgery questionnaire. The questions on this survey evaluate satisfaction with the most recent hospital stay (e.g. Did the care providers explain things in a way you could understand?). Each question presents a multiple choice response of either "Yes-definitely, Yes - mostly, Yes-somewhat, and No." For each question, a higher score indicates greater satisfaction with their visit.
  arm group label: L-WebTIPS
  arm group type: Experimental
  arm group label: L-WebINFO
  arm group type: No Intervention
  intervention type: Other
  intervention name: L-WebTIPS
  description: This mobile health application includes cultural adaption and grounding of a previously developed and tested tailored mHealth intervention, WebTIPS. LWebTIPS is a culturally adapted mHealth intervention that is aimed at the child and parent and strives to improve clinical outcomes and patient experience of Latinx children. Tailoring variables include: Simpatia, Religiosity and Familism.
  arm group label: L-WebTIPS
  criteria: 
  gender: All
  minimum age: 2 Years
  maximum age: 7 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Haydee Cortes, BA
  phone: 7144562838
  email: cortesh@hs.uci.edu
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of California, Irvine
  investigator full name: Zeev Kain
  investigator title: Distinguished Professor
  mesh term: Pain, Postoperative
  mesh term: Acute Pain
  sharing ipd: No