<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/NCT03014466</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-37577</org_study_id>
    <nct_id>NCT03014466</nct_id>
  </id_info>
  <brief_title>Screen-Based Distraction Tool for Preoperative Preparation</brief_title>
  <official_title>Screen-Based Distraction Tool for Preoperative Preparation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stanford University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Preoperative anxiety in pediatric patients undergoing surgical procedures has been previously&#xD;
      shown to increase the likelihood of family stressors, post- operative pain, agitation, sleep&#xD;
      disturbances, and negative behavioral changes. The purpose of this study is to determine&#xD;
      whether the use of a bed mounted Video Projection unit (i.e. BERT, Bedside EnterRtainment&#xD;
      Theater) is more effective than the use of a standard of care tablet (i.e., iPad) for&#xD;
      preventing anxiety before surgery among children undergoing anesthesia and surgery. The&#xD;
      anticipated primary outcome will be reduction of child's anxiety in the preoperative and&#xD;
      operating room setting and compliance with mask induction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients will initially be approached about the study during a pre-surgical phone call that&#xD;
      every patient receives prior to their procedure by a Nurse Practitioner (NP). During this&#xD;
      phone call, the NP will ask if the family would be interested in participating in a research&#xD;
      study and if they may be contacted by the research team. If the family expresses interest,&#xD;
      the NP will follow-up with the research team and a eligibility screening phone call will be&#xD;
      given. If families decline interest, we will respect their decision and will not pursue the&#xD;
      family any further for this study. Not all families will be available during the initial pre-&#xD;
      surgical phone call, and in this case, the medical staff member and research assistant will&#xD;
      approach the family in the pre-operative holding area day of surgery. Interested families&#xD;
      will be given a brochure with information about the study and screened for eligibility.&#xD;
&#xD;
      Upon arrival for preoperative preparations, the research assistant will go over the consent&#xD;
      and assent forms with the parent and child and answer any questions they may have about the&#xD;
      study. While child is being prepped to be transported to the preoperative holding area, a&#xD;
      research staff member will determine whether the participant will receive the standard care&#xD;
      (i.e. entertainment via tablet) or the (i.e. BERT, Bedside EnteRtainment System; Video&#xD;
      Projection) via random assignment. Once determined, the research staff will set up the system&#xD;
      for the patient and will be asked to fill out questionnaires, on REDCap or by paper, about&#xD;
      how they are feeling at that time before their surgery. Parents will also be asked to fill&#xD;
      out questionnaires about their feelings of their child's preoperative emotions. The child&#xD;
      will continue to view their preoperative entertainment through to induction. A video camera&#xD;
      mounted to the BERT screen or tablet will be used for retrospective coding by blinded&#xD;
      research assistants. When possible, a blinded research assistant will also live-code the&#xD;
      observer-rated surveys. We aim for this to occur for around 20-30% of participants. care) The&#xD;
      research assistants will complete the mYPAS (modified Yale Preoperative Anxiety Scale) and&#xD;
      ICC (Induction Compliance Checklist) when coding in vivo. Vitals (i.e. blood pressure, heart&#xD;
      rate, oxygen saturation, end tidal CO2, and temperature) will also be recorded as they&#xD;
      undergo preoperative preparations. The parent will be asked to remain with their child from&#xD;
      the preoperative holding area until the child has undergone induction. Once child enters&#xD;
      induction phase in the OR, the patient will undergo surgery as scheduled.&#xD;
&#xD;
      Post-operation, the research assistant will further examine the child's behaviors as they&#xD;
      wake from anesthesia. They will also give the the parent, child, and child's anesthesiologist&#xD;
      a survey about their experiences with the screen-based device. 1 week after the surgery, the&#xD;
      research assistant will follow up with the parent/guardian with questions about their and&#xD;
      their child's preoperative and perioperative via phone. The call will also be audio recorded.&#xD;
      After the one-week follow-up survey, the study will be concluded for the participant.&#xD;
&#xD;
      b) Explain how the above research procedures are the least risky that can be performed&#xD;
      consistent with sound research design.&#xD;
&#xD;
      All survey questions are meant to answer questions pertaining to the study aims. Set up of&#xD;
      the Video Projection unit will be performed by trained members of the research team and will&#xD;
      be of minimal risk to patients.&#xD;
&#xD;
      The risks associated with this study include the possibility of participation being&#xD;
      discovered by others outside of the study team. This is highly unlikely given the precautions&#xD;
      that will be described later in this application.&#xD;
&#xD;
      c) State if deception will be used. If so, provide the rationale and describe debriefing&#xD;
      procedures. Since you will not be fully informing the participant in your consent process and&#xD;
      form, complete an alteration of consent (in section 13). Submit a debriefing script (in&#xD;
      section 16).&#xD;
&#xD;
      Deception will not be used.&#xD;
&#xD;
      d) State if audio or video recording will occur. Describe what will become of the recording&#xD;
      after use, e.g., shown at scientific meetings, erased. Describe the final disposition of the&#xD;
      recordings.&#xD;
&#xD;
      Participants will be video taped to capture the patient's full experience with the Video&#xD;
      Projection unit and its effect during preoperative and perioperative procedure. The video&#xD;
      camera will be mounted on the tablet or BERT system. Videos will be coded by the research&#xD;
      team, and will not contain PHI. Audio will be recorded from the follow-up phone calls so that&#xD;
      the parents' responses will be fully captured in our measures. These videos and audio files&#xD;
      will be stored on a secured, password protected, and encrypted computer, which only&#xD;
      authorized members of the study will have access to. The videos and audio files will be&#xD;
      destroyed 6 years after the publication of the study. These videos and audio files may be&#xD;
      presented at scientific meetings and this will be included in the consent.&#xD;
&#xD;
      e) Describe alternative procedures or courses of treatment, if any, that might be&#xD;
      advantageous to the participant. Describe potential risks and benefits associated with these.&#xD;
      Any standard treatment that is being withheld must be disclosed in the consent process and&#xD;
      form. (i.e. standard-of-care drug, different interventional procedure, no procedure or&#xD;
      treatment, palliative care, other research studies).&#xD;
&#xD;
      This is a randomized trial to validate the effectiveness of using a Video Projection unit,&#xD;
      therefore there will be subjects that undergo standard treatment as a result of the&#xD;
      randomization. The randomization will be performed by the research assistant following&#xD;
      consent. Parents must be with their child from the pre-operative area until induction. They&#xD;
      will have the option to opt-out of the study if the parent or child does not want the parent&#xD;
      present or there is a strong patient or parent preference for pharmacological anxiolytic or a&#xD;
      specific anxiety-reduction technique.&#xD;
&#xD;
      f) Will it be possible to continue the more (most) appropriate therapy for the participant(s)&#xD;
      after the conclusion of the study?&#xD;
&#xD;
      N/A. The interventional technologies will only be implemented to allay preoperative anxiety,&#xD;
      therefore will not be continued after the surgery.&#xD;
&#xD;
      g) Study Endpoint. What are the guidelines or end points by which you can evaluate the&#xD;
      different treatments (i.e. study drug, device, procedure) during the study? If one proves to&#xD;
      be clearly more effective than another (or others) during the course of a study, will the&#xD;
      study be terminated before the projected total participant population has been enrolled? When&#xD;
      will the study end if no important differences are detected?&#xD;
&#xD;
      The endpoint of the study will be determined by the completion of the target number of&#xD;
      participants. The target number of participants for the study is 30 participants in each&#xD;
      randomized group (i.e. standard care tablet and Video Projection unit group) for a total of&#xD;
      60 patients who complete the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">January 2018</completion_date>
  <primary_completion_date type="Actual">January 2018</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Anxiety at Induction of Anesthesia</measure>
    <time_frame>30 minutes</time_frame>
    <description>Modified Yale Perioperative Anxiety Score at induction of anesthesia. This is a validated scale used to assess patient periprocedural anxiety</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Induction Compliance</measure>
    <time_frame>5 minutes</time_frame>
    <description>Validated score for assessing patient compliance with anesthesia</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Anxiety</condition>
  <arm_group>
    <arm_group_label>Tablet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Preoperative patients will utilize a video tablet for addressing pre anesthesia anxiety</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Video Projector</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Preoperative patients will utilize a video projection unit for addressing pre anesthesia anxiety</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Use of Video Projector</intervention_name>
    <description>Bed mounted video projector that is used to play videos of the patient's choosing prior to induction of anesthesia</description>
    <arm_group_label>Video Projector</arm_group_label>
    <other_name>Bedside Entertainment Theater</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Use of Video Tablet</intervention_name>
    <description>7 inch video tablet that is used for displaying videos of the patient's choosing prior to induction of anesthesia</description>
    <arm_group_label>Tablet</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Participants must:&#xD;
&#xD;
          1. be between ages of 4-10 years of age&#xD;
&#xD;
          2. have comprehension of instructions in the English language&#xD;
&#xD;
          3. have parental consent&#xD;
&#xD;
          4. Pediatric patient must be undergoing non-emergent outpatient surgery at Lucile Packard&#xD;
             Children's Hospital&#xD;
&#xD;
          5. Children who are normally healthy (ASA I) or have a mild systemic disease (ASA II) -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        General Exclusion Criteria are as follows:&#xD;
&#xD;
          1. Significant cognitive impairment/developmental delays per parental report or H&amp;P.&#xD;
&#xD;
          2. Children with ASA III, ASA IV (severe systemic disease that is a constant threat to&#xD;
             life) or ASA V (unstable patients not expected to survive &gt;24hours or without the&#xD;
             operation)&#xD;
&#xD;
          3. Children currently taking psychotropic mediations will be excluded from this study due&#xD;
             to the affect emotion modulation&#xD;
&#xD;
          4. Strong parental or patient preference for pharmacological anxiolytic&#xD;
&#xD;
          5. Strong parental or patient preference for specific anxiety-reducing technique&#xD;
&#xD;
          6. Children born before 32 week gestation&#xD;
&#xD;
          7. Any indication that the patient may be admitted post-operatively&#xD;
&#xD;
          8. Child has had previous surgery or has undergone general anesthesia&#xD;
&#xD;
          9. Parent does not want to be present during transport to the OR or during induction -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>10 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Samuel T Rodriguez, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford School of Medicine</affiliation>
  </overall_official>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>January 5, 2017</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <last_update_submitted>September 27, 2018</last_update_submitted>
  <last_update_submitted_qc>September 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 1, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Samuel Rodriguez</investigator_full_name>
    <investigator_title>Clinical Assistant Professor</investigator_title>
  </responsible_party>
  <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/NCT03014466
org study id: IRB-37577
nct id: NCT03014466
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Preoperative anxiety in pediatric patients undergoing surgical procedures has been previously
      shown to increase the likelihood of family stressors, post- operative pain, agitation, sleep
      disturbances, and negative behavioral changes. The purpose of this study is to determine
      whether the use of a bed mounted Video Projection unit (i.e. BERT, Bedside EnterRtainment
      Theater) is more effective than the use of a standard of care tablet (i.e., iPad) for
      preventing anxiety before surgery among children undergoing anesthesia and surgery. The
      anticipated primary outcome will be reduction of child's anxiety in the preoperative and
      operating room setting and compliance with mask induction.
Patients will initially be approached about the study during a pre-surgical phone call that
      every patient receives prior to their procedure by a Nurse Practitioner (NP). During this
      phone call, the NP will ask if the family would be interested in participating in a research
      study and if they may be contacted by the research team. If the family expresses interest,
      the NP will follow-up with the research team and a eligibility screening phone call will be
      given. If families decline interest, we will respect their decision and will not pursue the
      family any further for this study. Not all families will be available during the initial pre-
      surgical phone call, and in this case, the medical staff member and research assistant will
      approach the family in the pre-operative holding area day of surgery. Interested families
      will be given a brochure with information about the study and screened for eligibility.

      Upon arrival for preoperative preparations, the research assistant will go over the consent
      and assent forms with the parent and child and answer any questions they may have about the
      study. While child is being prepped to be transported to the preoperative holding area, a
      research staff member will determine whether the participant will receive the standard care
      (i.e. entertainment via tablet) or the (i.e. BERT, Bedside EnteRtainment System; Video
      Projection) via random assignment. Once determined, the research staff will set up the system
      for the patient and will be asked to fill out questionnaires, on REDCap or by paper, about
      how they are feeling at that time before their surgery. Parents will also be asked to fill
      out questionnaires about their feelings of their child's preoperative emotions. The child
      will continue to view their preoperative entertainment through to induction. A video camera
      mounted to the BERT screen or tablet will be used for retrospective coding by blinded
      research assistants. When possible, a blinded research assistant will also live-code the
      observer-rated surveys. We aim for this to occur for around 20-30% of participants. care) The
      research assistants will complete the mYPAS (modified Yale Preoperative Anxiety Scale) and
      ICC (Induction Compliance Checklist) when coding in vivo. Vitals (i.e. blood pressure, heart
      rate, oxygen saturation, end tidal CO2, and temperature) will also be recorded as they
      undergo preoperative preparations. The parent will be asked to remain with their child from
      the preoperative holding area until the child has undergone induction. Once child enters
      induction phase in the OR, the patient will undergo surgery as scheduled.

      Post-operation, the research assistant will further examine the child's behaviors as they
      wake from anesthesia. They will also give the the parent, child, and child's anesthesiologist
      a survey about their experiences with the screen-based device. 1 week after the surgery, the
      research assistant will follow up with the parent/guardian with questions about their and
      their child's preoperative and perioperative via phone. The call will also be audio recorded.
      After the one-week follow-up survey, the study will be concluded for the participant.

      b) Explain how the above research procedures are the least risky that can be performed
      consistent with sound research design.

      All survey questions are meant to answer questions pertaining to the study aims. Set up of
      the Video Projection unit will be performed by trained members of the research team and will
      be of minimal risk to patients.

      The risks associated with this study include the possibility of participation being
      discovered by others outside of the study team. This is highly unlikely given the precautions
      that will be described later in this application.

      c) State if deception will be used. If so, provide the rationale and describe debriefing
      procedures. Since you will not be fully informing the participant in your consent process and
      form, complete an alteration of consent (in section 13). Submit a debriefing script (in
      section 16).

      Deception will not be used.

      d) State if audio or video recording will occur. Describe what will become of the recording
      after use, e.g., shown at scientific meetings, erased. Describe the final disposition of the
      recordings.

      Participants will be video taped to capture the patient's full experience with the Video
      Projection unit and its effect during preoperative and perioperative procedure. The video
      camera will be mounted on the tablet or BERT system. Videos will be coded by the research
      team, and will not contain PHI. Audio will be recorded from the follow-up phone calls so that
      the parents' responses will be fully captured in our measures. These videos and audio files
      will be stored on a secured, password protected, and encrypted computer, which only
      authorized members of the study will have access to. The videos and audio files will be
      destroyed 6 years after the publication of the study. These videos and audio files may be
      presented at scientific meetings and this will be included in the consent.

      e) Describe alternative procedures or courses of treatment, if any, that might be
      advantageous to the participant. Describe potential risks and benefits associated with these.
      Any standard treatment that is being withheld must be disclosed in the consent process and
      form. (i.e. standard-of-care drug, different interventional procedure, no procedure or
      treatment, palliative care, other research studies).

      This is a randomized trial to validate the effectiveness of using a Video Projection unit,
      therefore there will be subjects that undergo standard treatment as a result of the
      randomization. The randomization will be performed by the research assistant following
      consent. Parents must be with their child from the pre-operative area until induction. They
      will have the option to opt-out of the study if the parent or child does not want the parent
      present or there is a strong patient or parent preference for pharmacological anxiolytic or a
      specific anxiety-reduction technique.

      f) Will it be possible to continue the more (most) appropriate therapy for the participant(s)
      after the conclusion of the study?

      N/A. The interventional technologies will only be implemented to allay preoperative anxiety,
      therefore will not be continued after the surgery.

      g) Study Endpoint. What are the guidelines or end points by which you can evaluate the
      different treatments (i.e. study drug, device, procedure) during the study? If one proves to
      be clearly more effective than another (or others) during the course of a study, will the
      study be terminated before the projected total participant population has been enrolled? When
      will the study end if no important differences are detected?

      The endpoint of the study will be determined by the completion of the target number of
      participants. The target number of participants for the study is 30 participants in each
      randomized group (i.e. standard care tablet and Video Projection unit group) for a total of
      60 patients who complete the study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Anxiety at Induction of Anesthesia
time frame: 30 minutes
description: Modified Yale Perioperative Anxiety Score at induction of anesthesia. This is a validated scale used to assess patient periprocedural anxiety
measure: Induction Compliance
time frame: 5 minutes
description: Validated score for assessing patient compliance with anesthesia
arm group label: Tablet
arm group type: Active Comparator
description: Preoperative patients will utilize a video tablet for addressing pre anesthesia anxiety
arm group label: Video Projector
arm group type: Experimental
description: Preoperative patients will utilize a video projection unit for addressing pre anesthesia anxiety
intervention type: Behavioral
intervention name: Use of Video Projector
description: Bed mounted video projector that is used to play videos of the patient's choosing prior to induction of anesthesia
arm group label: Video Projector
other name: Bedside Entertainment Theater
intervention type: Behavioral
intervention name: Use of Video Tablet
description: 7 inch video tablet that is used for displaying videos of the patient's choosing prior to induction of anesthesia
arm group label: Tablet
criteria: 
gender: All
minimum age: 4 Years
maximum age: 10 Years
healthy volunteers: No
last name: Samuel T Rodriguez, MD
role: Principal Investigator
affiliation: Stanford School of Medicine
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Samuel Rodriguez
investigator title: Clinical Assistant Professor
sharing ipd: No