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/NCT05982249</url>
    </required_header>
    <id_info>
      <org_study_id>0053-23-BNZ</org_study_id>
      <nct_id>NCT05982249</nct_id>
    </id_info>
    <brief_title>Hypnosis, Virtual Reality and Their Combination in Bone Marrow Examination</brief_title>
    <official_title>Effectiveness of Recorded Hypnosis, Virtual Reality or Their Combination in Patients Undergoing a Bone Marrow Examination at the Hematology Unit</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Bnai Zion Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Bnai Zion Medical Center</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>
        The goal of this clinical trial is to compare the effects of hypnosis, virtual reality or&#xD;
        their combination in patients undergoing a bone marrow procedure.&#xD;
  &#xD;
        The main question it aims to answer is whether such interventions may relieve anxiety and&#xD;
        other symptoms described by patients undergoing the procedure.&#xD;
  &#xD;
        Before the bone marrow procedure and after being explained on the study and signing informed&#xD;
        consent, the nurse will measure vital signs and participants will fill-out a 2-minutes'&#xD;
        questionnaire and will be assigned to one of 4 groups:&#xD;
  &#xD;
          -  Hearing a 7-minutes hypnotic script via earphones&#xD;
  &#xD;
          -  Seeing and hearing virtual images and sounds via a virtual reality device during 7&#xD;
             minutes&#xD;
  &#xD;
          -  Both heating a 7-minutes hypnotic script via earphones and seeing virtual images via a&#xD;
             virtual reality device&#xD;
  &#xD;
          -  None of these After these interventions or 10 minutes after assignation for patients not&#xD;
             receiving intervention, patients will fill questionnaires again (about 5 minutes for&#xD;
             filling the 2 questionnaires) and vital signs will be measured again. Then the bone&#xD;
             marrow procedure will be performed. After the bone marrow procedure, the participants&#xD;
             will fill-out another 2-minutes questionnaire and vital signs will be measured by the&#xD;
             nurse.&#xD;
  &#xD;
        Researchers will compare hypnotic script, virtual reality, their combination or none of them&#xD;
        to see if they can affect anxiety and other complaints in patients undergoing a bone marrow&#xD;
        procedure.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 13, 2023</start_date>
    <completion_date type="Anticipated">July 2026</completion_date>
    <primary_completion_date type="Anticipated">July 2026</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>Open label randomized controlled trial</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Symptoms experienced by patients undergoing bone marrow procedure</measure>
      <time_frame>Through study completion, an average of 1 hour</time_frame>
      <description>Measure Yourself Concerns and Wellbeing (MYCAW) questionnaire: requires participants to nominate one or two concerns and, using a seven-point scale from 0 (worse outcome) to 6 (best outcome), to score these concerns and their general feeling of wellbeing</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Absorption, dissociation, immersion and time perception</measure>
      <time_frame>Through study completion, an average of 1 hour</time_frame>
      <description>Validated questionnaire on absorption, dissociation, immersion and time perception</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sedation</measure>
      <time_frame>Through study completion, an average of 1 hour</time_frame>
      <description>Type and dose of sedation used during procedure</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Use of analgesics</measure>
      <time_frame>Through study completion, an average of 1 hour</time_frame>
      <description>Type and dose of analgesics</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood pressure</measure>
      <time_frame>Through study completion, an average of 1 hour</time_frame>
      <description>Blood pressure</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pulse</measure>
      <time_frame>Through study completion, an average of 1 hour</time_frame>
      <description>Pulse</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Respiratory rate</measure>
      <time_frame>Through study completion, an average of 1 hour</time_frame>
      <description>Respiratory rate</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Hematologic Diseases</condition>
    <arm_group>
      <arm_group_label>Hypnosis (H)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients will be given earphones to hear a hypnotic script that was recorded by Dr. Zahi Arnon, a psychologist specializing in hypnosis after observing about ten bone marrow (BM) examinations at the hematology institute. The length of the recording is about 7 minutes.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Virtual reality (VR)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients will be connected to a VR device that will transmit to the patient's choice a 3D screen and soothing noise for about 7 minutes.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Combined hypnosis and virtual reality (VRH)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients will hear the same 7-minutes hypnotic script by earphones and simultaneously be connected to the VR device that will show the 3D screen without soothing noise.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control (C)</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Hypnosis</intervention_name>
      <description>Patients will be given earphones to hear a hypnotic script that was recorded by Dr. Zahi Arnon, a psychologist specializing in hypnosis after observing about ten BM examinations at the hematology institute. The length of the recording is about 7 minutes.</description>
      <arm_group_label>Combined hypnosis and virtual reality (VRH)</arm_group_label>
      <arm_group_label>Hypnosis (H)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Virtual reality (VR)</intervention_name>
      <description>Patients will be connected to a VR device that will transmit to the patient's choice a 3D screen and soothing noise for about 7 minutes.</description>
      <arm_group_label>Combined hypnosis and virtual reality (VRH)</arm_group_label>
      <arm_group_label>Virtual reality (VR)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age 18 or older&#xD;
  &#xD;
            2. Candidate for a BM examination at the hematology unit&#xD;
  &#xD;
            3. Ability to answer questionnaires in Hebrew, Arabic or Russian&#xD;
  &#xD;
            4. Informed consent form signing&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Major hearing impairment&#xD;
  &#xD;
            2. Major visual impairment.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ilana Levy Yurkovski, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Bnai Zion Medical Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Dana Weizer</last_name>
      <phone>+972543295952</phone>
      <email>dana.weizer@b-zion.org.il</email>
    </overall_contact>
    <location>
      <facility>
        <name>Bnai Zion Medical Center</name>
        <address>
          <city>Haifa</city>
          <zip>3339419</zip>
          <country>Israel</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ilana Levy Yurkovski, MD</last_name>
        <phone>+972525086128</phone>
        <email>ilana.levy@b-zion.org.il</email>
      </contact>
      <investigator>
        <last_name>Ilana Levy Yurkovski, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Dina Libes, RN</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Tamar Tadmor, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Nataly Kreiniz, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Laila Hakhrush, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Israel</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 16, 2023</study_first_submitted>
    <study_first_submitted_qc>July 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>July 30, 2023</last_update_submitted>
    <last_update_submitted_qc>July 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Bone marrow</keyword>
    <keyword>Procedure</keyword>
    <keyword>Hematology</keyword>
    <keyword>Hypnosis</keyword>
    <keyword>Guided imagery</keyword>
    <keyword>Virtual reality</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hematologic Diseases</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>July 5, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/49/NCT05982249/Prot_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- 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/NCT05982249
  org study id: 0053-23-BNZ
  nct id: NCT05982249
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to compare the effects of hypnosis, virtual reality or
        their combination in patients undergoing a bone marrow procedure.
  
        The main question it aims to answer is whether such interventions may relieve anxiety and
        other symptoms described by patients undergoing the procedure.
  
        Before the bone marrow procedure and after being explained on the study and signing informed
        consent, the nurse will measure vital signs and participants will fill-out a 2-minutes'
        questionnaire and will be assigned to one of 4 groups:
  
          -  Hearing a 7-minutes hypnotic script via earphones
  
          -  Seeing and hearing virtual images and sounds via a virtual reality device during 7
             minutes
  
          -  Both heating a 7-minutes hypnotic script via earphones and seeing virtual images via a
             virtual reality device
  
          -  None of these After these interventions or 10 minutes after assignation for patients not
             receiving intervention, patients will fill questionnaires again (about 5 minutes for
             filling the 2 questionnaires) and vital signs will be measured again. Then the bone
             marrow procedure will be performed. After the bone marrow procedure, the participants
             will fill-out another 2-minutes questionnaire and vital signs will be measured by the
             nurse.
  
        Researchers will compare hypnotic script, virtual reality, their combination or none of them
        to see if they can affect anxiety and other complaints in patients undergoing a bone marrow
        procedure.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Open label randomized controlled trial
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Symptoms experienced by patients undergoing bone marrow procedure
  time frame: Through study completion, an average of 1 hour
  description: Measure Yourself Concerns and Wellbeing (MYCAW) questionnaire: requires participants to nominate one or two concerns and, using a seven-point scale from 0 (worse outcome) to 6 (best outcome), to score these concerns and their general feeling of wellbeing
  measure: Absorption, dissociation, immersion and time perception
  time frame: Through study completion, an average of 1 hour
  description: Validated questionnaire on absorption, dissociation, immersion and time perception
  measure: Sedation
  time frame: Through study completion, an average of 1 hour
  description: Type and dose of sedation used during procedure
  measure: Use of analgesics
  time frame: Through study completion, an average of 1 hour
  description: Type and dose of analgesics
  measure: Blood pressure
  time frame: Through study completion, an average of 1 hour
  description: Blood pressure
  measure: Pulse
  time frame: Through study completion, an average of 1 hour
  description: Pulse
  measure: Respiratory rate
  time frame: Through study completion, an average of 1 hour
  description: Respiratory rate
  arm group label: Hypnosis (H)
  arm group type: Experimental
  description: Patients will be given earphones to hear a hypnotic script that was recorded by Dr. Zahi Arnon, a psychologist specializing in hypnosis after observing about ten bone marrow (BM) examinations at the hematology institute. The length of the recording is about 7 minutes.
  arm group label: Virtual reality (VR)
  arm group type: Experimental
  description: Patients will be connected to a VR device that will transmit to the patient's choice a 3D screen and soothing noise for about 7 minutes.
  arm group label: Combined hypnosis and virtual reality (VRH)
  arm group type: Experimental
  description: Patients will hear the same 7-minutes hypnotic script by earphones and simultaneously be connected to the VR device that will show the 3D screen without soothing noise.
  arm group label: Control (C)
  arm group type: No Intervention
  intervention type: Device
  intervention name: Hypnosis
  description: Patients will be given earphones to hear a hypnotic script that was recorded by Dr. Zahi Arnon, a psychologist specializing in hypnosis after observing about ten BM examinations at the hematology institute. The length of the recording is about 7 minutes.
  arm group label: Combined hypnosis and virtual reality (VRH)
  arm group label: Hypnosis (H)
  intervention type: Device
  intervention name: Virtual reality (VR)
  description: Patients will be connected to a VR device that will transmit to the patient's choice a 3D screen and soothing noise for about 7 minutes.
  arm group label: Combined hypnosis and virtual reality (VRH)
  arm group label: Virtual reality (VR)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Ilana Levy Yurkovski, MD
  role: Principal Investigator
  affiliation: Bnai Zion Medical Center
  last name: Dana Weizer
  phone: +972543295952
  email: dana.weizer@b-zion.org.il
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: Israel
  responsible party type: Sponsor
  mesh term: Hematologic Diseases
  sharing ipd: No
  provided document: 