<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/NCT04401514</url>
  </required_header>
  <id_info>
    <org_study_id>RockingICU</org_study_id>
    <nct_id>NCT04401514</nct_id>
  </id_info>
  <brief_title>Does Rocking Charis Calm Delirious Patients in the Intensive Care Unit</brief_title>
  <acronym>RocingICU</acronym>
  <official_title>Does ROCKING Chairs Calm Delirious Patients in the Intensive Care Unit: a Multicenter Clinical Randomized Trial (RockingICU)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Scandinavian Critical Care Trials Group</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Scandinavian Critical Care Trials Group</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: Delirium among patients admitted to an ICU is a common condition associated with&#xD;
      increased morbidity and mortality. To this point no evidence-based prevention or treatment&#xD;
      exist for delirium. Non-pharmacological interventions such as early mobilization and&#xD;
      systematic bundle of care have been suggested to decrease the number of days of delirium. So&#xD;
      far there exist no studies exploring if delirious patients benefit or not when mobilized to a&#xD;
      rocking chair with music therapy.&#xD;
&#xD;
      Objectives: To assess if rocking chair therapy can decrease the burden of delirium in adult,&#xD;
      critical ill patients admitted to an ICU.&#xD;
&#xD;
      Design: A clinical initiated multicenter randomized non-blinded trial, of delirious patients&#xD;
      mobilized to a rocking chair versus no rocking chair.&#xD;
&#xD;
      Inclusion and exclusion criteria: Inclusion criteria: Adult intensive care patients (18 years&#xD;
      and above) diagnosed with delirium with a validated screening tool. Exclusion criteria: if&#xD;
      the patient is evaluated not to be mobilized to a rocking chair and expressing discomfort and&#xD;
      do not wish to be mobilized, a patient with critical illness neuropati, patients with lever&#xD;
      coma, patient in ECM treatment, patients that are mentally permanently incompetent, not&#xD;
      receiving active life support if needed, weight more that 130 kg, if informed consent cannot&#xD;
      be obtained, if the patient is admitted because of suicide attempt and is the patient have&#xD;
      delirium tremens.&#xD;
&#xD;
      Intervention: The experimental intervention is a 20 min. long rocking chair with music&#xD;
      therapy. Control intervention is also transferred to the rocking chair, but the therapy&#xD;
      program will not be turned on. Standardized pharmacological and non-pharmacological&#xD;
      interventions for delirium will continue for both groups. Delirium and consciousness will be&#xD;
      evaluated twice a day.&#xD;
&#xD;
      Outcomes: Primary outcome: number of days alive without coma and delirium in the ICU.&#xD;
      Secondary outcome: Number of days admitted to the ICU and number of patients with at least&#xD;
      one difference in RASS score before end after the experimental intervention.&#xD;
&#xD;
      Trial size: A power calculation have estimated that a total number of 76 patients with&#xD;
      delirium should be included in each study group.&#xD;
&#xD;
      Time schedule: We estimate that the inclusion period and follow up will as long as 1 year&#xD;
      from the time the first patient is randomized.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The intervention is a 30 min long transfer to a rocking chair with music cure therapy. For&#xD;
      the intervention group, the intervention will be turned on and for the control, the rocking&#xD;
      and music function will not be turned on.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Anticipated">December 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 1, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>number of days alive without coma and delirium in the ICU</measure>
    <time_frame>14 day follow up</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of days admitted to the ICU</measure>
    <time_frame>14 day follow up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Delta RASS</measure>
    <time_frame>14 day follow up</time_frame>
    <description>RASS score goes from +4 very agitated to -5 is coma. A score of 0 is equal to alert and calm</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">152</enrollment>
  <condition>Delirium</condition>
  <arm_group>
    <arm_group_label>Experiemntal intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The experimental intervention is a 20 min. long rocking chair with music therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Control intervention is also transferred to the rocking chair, but the therapy program will not be turned on.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Rocking chair therapy</intervention_name>
    <description>20 min long rocking therapy with music cure. The therapy can be extended if needed</description>
    <arm_group_label>Control intervention</arm_group_label>
    <arm_group_label>Experiemntal intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  admitted to ICU&#xD;
&#xD;
          -  positive delirium evaluation with CAM-ICU or ICDSC&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  if the patient is evaluated not to be mobilized to a rocking chair&#xD;
&#xD;
          -  expressing discomfort and do not wish to be mobilized&#xD;
&#xD;
          -  patients with critical illness neuropathy&#xD;
&#xD;
          -  patients with levercoma&#xD;
&#xD;
          -  patient in ECOM (exstracorporel membrane oxygenation) treatment&#xD;
&#xD;
          -  patients that are mentally permanently incompetent&#xD;
&#xD;
          -  patients not receiving active life support if needed&#xD;
&#xD;
          -  patients that weight more than 130 kg&#xD;
&#xD;
          -  patients were informed consent cannot be obtained&#xD;
&#xD;
          -  patients admitted because of suicide attempt&#xD;
&#xD;
          -  patients with delirium tremens&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>110 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ingrid Egerod, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>Department of Intensive care, Copenhagen University Hospital, Denmark</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Marie O Collet, Nurse</last_name>
    <phone>+44535456949</phone>
    <email>marie.oxenboell-collet@regionh.dk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Gitte M Nielsen, Nurse</last_name>
    <phone>35454131</phone>
    <email>gitte.meldgaard.nielsen@regionh.dk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Copenhagen University Hospital, Rigshospitalet</name>
      <address>
        <city>Copenhagen</city>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anders Perner, MD PhD</last_name>
      <phone>+4535458333</phone>
      <email>anders.perner@regionh.dk</email>
    </contact>
    <contact_backup>
      <last_name>Peter B Hjortrup, MD</last_name>
      <phone>+4535458456</phone>
      <email>peter.buhl.hjortrup@regionh.dk</email>
    </contact_backup>
    <investigator>
      <last_name>Anders Perner, MD PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>November 4, 2019</study_first_submitted>
  <study_first_submitted_qc>May 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>November 12, 2020</last_update_submitted>
  <last_update_submitted_qc>November 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Scandinavian Critical Care Trials Group</investigator_affiliation>
    <investigator_full_name>Anders Perner</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Delirium</mesh_term>
  </condition_browse>
  <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/NCT04401514
org study id: RockingICU
nct id: NCT04401514
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Background: Delirium among patients admitted to an ICU is a common condition associated with
      increased morbidity and mortality. To this point no evidence-based prevention or treatment
      exist for delirium. Non-pharmacological interventions such as early mobilization and
      systematic bundle of care have been suggested to decrease the number of days of delirium. So
      far there exist no studies exploring if delirious patients benefit or not when mobilized to a
      rocking chair with music therapy.

      Objectives: To assess if rocking chair therapy can decrease the burden of delirium in adult,
      critical ill patients admitted to an ICU.

      Design: A clinical initiated multicenter randomized non-blinded trial, of delirious patients
      mobilized to a rocking chair versus no rocking chair.

      Inclusion and exclusion criteria: Inclusion criteria: Adult intensive care patients (18 years
      and above) diagnosed with delirium with a validated screening tool. Exclusion criteria: if
      the patient is evaluated not to be mobilized to a rocking chair and expressing discomfort and
      do not wish to be mobilized, a patient with critical illness neuropati, patients with lever
      coma, patient in ECM treatment, patients that are mentally permanently incompetent, not
      receiving active life support if needed, weight more that 130 kg, if informed consent cannot
      be obtained, if the patient is admitted because of suicide attempt and is the patient have
      delirium tremens.

      Intervention: The experimental intervention is a 20 min. long rocking chair with music
      therapy. Control intervention is also transferred to the rocking chair, but the therapy
      program will not be turned on. Standardized pharmacological and non-pharmacological
      interventions for delirium will continue for both groups. Delirium and consciousness will be
      evaluated twice a day.

      Outcomes: Primary outcome: number of days alive without coma and delirium in the ICU.
      Secondary outcome: Number of days admitted to the ICU and number of patients with at least
      one difference in RASS score before end after the experimental intervention.

      Trial size: A power calculation have estimated that a total number of 76 patients with
      delirium should be included in each study group.

      Time schedule: We estimate that the inclusion period and follow up will as long as 1 year
      from the time the first patient is randomized.
The intervention is a 30 min long transfer to a rocking chair with music cure therapy. For
      the intervention group, the intervention will be turned on and for the control, the rocking
      and music function will not be turned on.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: number of days alive without coma and delirium in the ICU
time frame: 14 day follow up
measure: Number of days admitted to the ICU
time frame: 14 day follow up
measure: Delta RASS
time frame: 14 day follow up
description: RASS score goes from +4 very agitated to -5 is coma. A score of 0 is equal to alert and calm
arm group label: Experiemntal intervention
arm group type: Experimental
description: The experimental intervention is a 20 min. long rocking chair with music therapy.
arm group label: Control intervention
arm group type: Active Comparator
description: Control intervention is also transferred to the rocking chair, but the therapy program will not be turned on.
intervention type: Device
intervention name: Rocking chair therapy
description: 20 min long rocking therapy with music cure. The therapy can be extended if needed
arm group label: Control intervention
arm group label: Experiemntal intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 110 Years
healthy volunteers: No
last name: Ingrid Egerod, Professor
role: Study Chair
affiliation: Department of Intensive care, Copenhagen University Hospital, Denmark
last name: Marie O Collet, Nurse
phone: +44535456949
email: marie.oxenboell-collet@regionh.dk
last name: Gitte M Nielsen, Nurse
phone: 35454131
email: gitte.meldgaard.nielsen@regionh.dk
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Scandinavian Critical Care Trials Group
investigator full name: Anders Perner
investigator title: Professor
mesh term: Delirium
sharing ipd: No