<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/NCT03832309</url>
  </required_header>
  <id_info>
    <org_study_id>2017196</org_study_id>
    <nct_id>NCT03832309</nct_id>
  </id_info>
  <brief_title>Techniques to Reduce the Severity and Frequency of Emergent Reactions</brief_title>
  <official_title>Non-Pharmacological Techniques to Reduce the Severity and Frequency of Emergency Reactions After Procedural Sedation and Analgesia in the Emergency Department</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CHRISTUS Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CHRISTUS Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objectives of this study are first to determine if the power of suggestion will decrease&#xD;
      the frequency and severity of emergence reactions after procedural sedation and analgesia&#xD;
      with ketamine in the setting of the emergency department. Second, to determine if people&#xD;
      dream about what they were thinking about when they were induced with ketamine.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The proposed research will be single blinded (patient) randomized controlled trial with a&#xD;
      retrospective component to test the hypothesis that the power of suggestion will reduce the&#xD;
      frequency and severity of emergence reactions, even in the setting of the emergency&#xD;
      department.&#xD;
&#xD;
      The study will be conducted in the emergency department at CHRISTU Spohn Shoreline Hospital.&#xD;
      CHRISTUS Spohn Shore hospital is the region's primary acute care center. It houses the Chest&#xD;
      Pain, Stroke, and Cancer Centers of CHRISTUS Spohn, and the only level II trauma center in&#xD;
      south Texas. It is a major teaching affiliate of Texas A&amp;M medical school, and serves an&#xD;
      inner-city population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Not enough recruitment.&#xD;
  </why_stopped>
  <start_date type="Actual">November 21, 2017</start_date>
  <completion_date type="Actual">June 21, 2021</completion_date>
  <primary_completion_date type="Actual">June 21, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>The study will be conducted in the emergency department at CHRISTUS Spohn Shoreline hospital is the region's primary acute care center. It houses the Chest Pain, Stroke, and Cancer Centers of CHRISTUS Spohn and is the only level II trauma center in south Texas. It is a major affiliate of Texas A&amp; M medical school, and serves an inner-city population</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>During the consent for the study, the physician will do the following depending on which group the patient has been randomized to: Packet 1: The physician will be asked to instruct the patient as empathetically and confidently as possible, that the drug the patient will be given will make them feel not pain, cause them to forget the procedure, and allow them to dream the dream of their choice. The resident will specifically ask the patient what he or she wants to dream about and the resident will then write the patient's answer on the instruction sheet. Packet #2: They physician will be asked to read a written statement about how the drug they will be given will cause analgesia, amnesia, and may cause hallucinations.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>T-Test</measure>
    <time_frame>24 months</time_frame>
    <description>Data gathered from post sedation questionnaire, specifically question 5, will be analyzed by comparing the two means of group one and group two using a student's T test,</description>
  </primary_outcome>
  <primary_outcome>
    <measure>STAI-6</measure>
    <time_frame>24 months</time_frame>
    <description>To ensure two groups are similar to each other -demographic data, the pre and post opt sedation VAS scores, and the STAI-6 information.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Analgesia</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Packet 1: The Physician will be asked to instruct the patient as empathetically and confidently as possible, that the drug the patient will be given will make them feel no pain, cause them to forget the procedure, and allow them to dream the dream of their choice.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Arm</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Half of the participants will receive the sedation medication with the usual conversation while the physician is giving the medication to the patient. The other half of the participants will have a more positive conversation, (which is the study intervention), with the physician while being given the medication. Both group's emergence reactions, if any, will be compared to see if the positive conversation reduced the side effect.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Do we speak to them in a way that convinces them to have the dream</intervention_name>
    <description>During induction, and depending on what group they are randomized to, the physician will speak to them about having a dream while on the drug</description>
    <arm_group_label>Control Arm</arm_group_label>
    <arm_group_label>Group 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Speaking to them as a regualar person</intervention_name>
    <description>During induction, if the patient is in group 1, the resident performing procedural sedation will remind the patient about what the patient wanted to dream and ask them to focus on that as the ketamine is being administered. If the patient is in group 2, the resident performing procedural sedation will give no specific instruction to the patient at this point.</description>
    <arm_group_label>Control Arm</arm_group_label>
    <arm_group_label>Group 1</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be at least 18 years of age&#xD;
&#xD;
          -  Required need for procedural sedation and analgesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age&lt; 18&#xD;
&#xD;
          -  Hypertension&#xD;
&#xD;
          -  Raised Intracranial pressure&#xD;
&#xD;
          -  Major psychological disorders&#xD;
&#xD;
          -  Procedures involving laryngel manipulations&#xD;
&#xD;
          -  History of Laryngeal sapsm History of adverse reactions to ketamine&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Paul Crapo, DO</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHRISTUS Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHRISTUS Health</name>
      <address>
        <city>Corpus Christi</city>
        <state>Texas</state>
        <zip>78404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>August 2, 2018</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>April 5, 2022</last_update_submitted>
  <last_update_submitted_qc>April 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03832309
org study id: 2017196
nct id: NCT03832309
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The objectives of this study are first to determine if the power of suggestion will decrease
      the frequency and severity of emergence reactions after procedural sedation and analgesia
      with ketamine in the setting of the emergency department. Second, to determine if people
      dream about what they were thinking about when they were induced with ketamine.
The proposed research will be single blinded (patient) randomized controlled trial with a
      retrospective component to test the hypothesis that the power of suggestion will reduce the
      frequency and severity of emergence reactions, even in the setting of the emergency
      department.

      The study will be conducted in the emergency department at CHRISTU Spohn Shoreline Hospital.
      CHRISTUS Spohn Shore hospital is the region's primary acute care center. It houses the Chest
      Pain, Stroke, and Cancer Centers of CHRISTUS Spohn, and the only level II trauma center in
      south Texas. It is a major teaching affiliate of Texas A&M medical school, and serves an
      inner-city population.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The study will be conducted in the emergency department at CHRISTUS Spohn Shoreline hospital is the region's primary acute care center. It houses the Chest Pain, Stroke, and Cancer Centers of CHRISTUS Spohn and is the only level II trauma center in south Texas. It is a major affiliate of Texas A& M medical school, and serves an inner-city population
primary purpose: Other
masking: Single (Participant)
masking description: During the consent for the study, the physician will do the following depending on which group the patient has been randomized to: Packet 1: The physician will be asked to instruct the patient as empathetically and confidently as possible, that the drug the patient will be given will make them feel not pain, cause them to forget the procedure, and allow them to dream the dream of their choice. The resident will specifically ask the patient what he or she wants to dream about and the resident will then write the patient's answer on the instruction sheet. Packet #2: They physician will be asked to read a written statement about how the drug they will be given will cause analgesia, amnesia, and may cause hallucinations.
measure: T-Test
time frame: 24 months
description: Data gathered from post sedation questionnaire, specifically question 5, will be analyzed by comparing the two means of group one and group two using a student's T test,
measure: STAI-6
time frame: 24 months
description: To ensure two groups are similar to each other -demographic data, the pre and post opt sedation VAS scores, and the STAI-6 information.
arm group label: Group 1
arm group type: Active Comparator
description: Packet 1: The Physician will be asked to instruct the patient as empathetically and confidently as possible, that the drug the patient will be given will make them feel no pain, cause them to forget the procedure, and allow them to dream the dream of their choice.
arm group label: Control Arm
arm group type: Other
description: Half of the participants will receive the sedation medication with the usual conversation while the physician is giving the medication to the patient. The other half of the participants will have a more positive conversation, (which is the study intervention), with the physician while being given the medication. Both group's emergence reactions, if any, will be compared to see if the positive conversation reduced the side effect.
intervention type: Behavioral
intervention name: Do we speak to them in a way that convinces them to have the dream
description: During induction, and depending on what group they are randomized to, the physician will speak to them about having a dream while on the drug
arm group label: Control Arm
arm group label: Group 1
intervention type: Behavioral
intervention name: Speaking to them as a regualar person
description: During induction, if the patient is in group 1, the resident performing procedural sedation will remind the patient about what the patient wanted to dream and ask them to focus on that as the ketamine is being administered. If the patient is in group 2, the resident performing procedural sedation will give no specific instruction to the patient at this point.
arm group label: Control Arm
arm group label: Group 1
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Paul Crapo, DO
role: Principal Investigator
affiliation: CHRISTUS Health
facility: 
country: United States
responsible party type: Sponsor