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/NCT05970029</url>
    </required_header>
    <id_info>
      <org_study_id>0014-23-CMC</org_study_id>
      <nct_id>NCT05970029</nct_id>
    </id_info>
    <brief_title>Influence of the Communication Between Nursing Staff and Patients on the Analgesic Response Following Caesarean Section</brief_title>
    <official_title>Influence of the Communication Between Nursing Staff and Patients on the Analgesic Response Following Caesarean Section</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Haifa</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Haifa</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>
        Effective management of postoperative pain is a priority for women undergoing cesarean&#xD;
        delivery. Despite availability of modern analgesics, postoperative pain management remains a&#xD;
        challenge.&#xD;
  &#xD;
        One opportunity to enhance the analgesic effect of the pharmacological treatments given to&#xD;
        people suffering from pain (and not just pain) is through increasing the expectations for&#xD;
        pain relief following treatment. Although much knowledge has been accumulated about the&#xD;
        significant effect of expectations on pain, virtually all evidence are based on experimental&#xD;
        studies carried out in laboratory settings, and there is a need to investigate how this&#xD;
        knowledge could translated into improved clinical care.&#xD;
  &#xD;
        The aim of the current study is to examine whether the communication style between the&#xD;
        nursing staff and the patient during analgesic administration will affect the results of pain&#xD;
        relief treatment in the mother-newborn ward after cesarean section. As another goal, the&#xD;
        study will examine whether relevant patient's characteristics will predict the effectiveness&#xD;
        of the treatment.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study will be carried out in the maternity ward at Carmel Hospital. The study population&#xD;
        will include patients who are about to undergo an elective caesarean section under spinal&#xD;
        anesthesia. The recruitment will be done pre-surgery. Following consent, participants will&#xD;
        receive an explanation about how to assess pain and will fill out the research&#xD;
        questionnaires. Communication is the independent variable in this study , which has 2 levels&#xD;
        - the increased communication arm and the normal communication arm. Each arm will include 40&#xD;
        patients that will be randomly divided between the arms. The dependent variable is the&#xD;
        treatment efficacy, based on the changes in the intensity of the patient's pain one hour&#xD;
        after the administration of analgesic. The Self-Consciousness Scale (SCS-R) and the Short&#xD;
        suggestibility scale (SSS) will be used to assess relevant personality traits.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 1, 2023</start_date>
    <completion_date type="Anticipated">March 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 1, 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>
      <intervention_model_description>Parallel design - subjects are allocated into one of two study arms</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
      <masking_description>At the time of analgesic request the nurse will open an envelop in which the participant assignment will be described. While the nurse (the communicator) is not blinded, the participants are blinded. The pain intensity reports will be recoded by the participants via a secured link, hence the participants are also the outcome assessor.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Change in pain intensity on the 0-10 pain scale</measure>
      <time_frame>one hour</time_frame>
      <description>Change in pain intensity one hour following administration of analgesics</description>
    </primary_outcome>
    <other_outcome>
      <measure>The Self-Consciousness Scale (SCS-R)</measure>
      <time_frame>Once, at baseline</time_frame>
      <description>Assessment of direction of attention. Three variables are calculated (private and public attention and social anxiety)</description>
    </other_outcome>
    <other_outcome>
      <measure>The Short suggestibility scale (SSS)</measure>
      <time_frame>Once, at baseline</time_frame>
      <description>Assessment of suggestibility score, ranging from 21 to 84, higher scores represent more tendency to suggestibility</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Acute Pain</condition>
    <arm_group>
      <arm_group_label>Enhanced communication</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In the enhanced communication study arm the nurse will say to the patient: &quot;I will now give you our first line analgesic medication, liquid Dipyrone. It is a very efficient treatment and based on my experience you will very soon feel significant pain relief&quot;.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Normal communication</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>In the normal communication study arm the communication between the nurse and patients will be as usual in clinical practice - i.e. - no instruction are given to the nurses regarding on how to communicate with patients while administrating the treatment.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Communication style</intervention_name>
      <description>The verbal communication between the nurse and the patient at the time of analgesic administration</description>
      <arm_group_label>Enhanced communication</arm_group_label>
      <arm_group_label>Normal communication</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Be able to provide signed and dated written informed consent and to be compliant with&#xD;
               the schedule of protocol assessments.&#xD;
  &#xD;
            -  Females aged 18 till 50&#xD;
  &#xD;
            -  Undergoing cesarean section&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          * Mental retardation and cognitive impairment&#xD;
  &#xD;
          study.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Only woman undergoing cesarian section</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Vered Cohen, BA</last_name>
      <role>Principal Investigator</role>
      <affiliation>Carmel Medical Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Vered Cohen, BA</last_name>
      <phone>972-525213440</phone>
      <email>golanv35@walla.co.il</email>
    </overall_contact>
    <location>
      <facility>
        <name>Carmel Medical Center</name>
        <address>
          <city>Haifa</city>
          <country>Israel</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Vered Cohen</last_name>
        <phone>+972525213440</phone>
        <email>veredcohen1@clalit.org.il</email>
      </contact>
    </location>
    <location_countries>
      <country>Israel</country>
    </location_countries>
    <verification_date>April 2023</verification_date>
    <study_first_submitted>April 20, 2023</study_first_submitted>
    <study_first_submitted_qc>July 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 23, 2023</last_update_submitted>
    <last_update_submitted_qc>July 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Acute Pain</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>A link to the data location will be published in the article summarizing the results</ipd_description>
    </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/NCT05970029
  org study id: 0014-23-CMC
  nct id: NCT05970029
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Effective management of postoperative pain is a priority for women undergoing cesarean
        delivery. Despite availability of modern analgesics, postoperative pain management remains a
        challenge.
  
        One opportunity to enhance the analgesic effect of the pharmacological treatments given to
        people suffering from pain (and not just pain) is through increasing the expectations for
        pain relief following treatment. Although much knowledge has been accumulated about the
        significant effect of expectations on pain, virtually all evidence are based on experimental
        studies carried out in laboratory settings, and there is a need to investigate how this
        knowledge could translated into improved clinical care.
  
        The aim of the current study is to examine whether the communication style between the
        nursing staff and the patient during analgesic administration will affect the results of pain
        relief treatment in the mother-newborn ward after cesarean section. As another goal, the
        study will examine whether relevant patient's characteristics will predict the effectiveness
        of the treatment.
  The study will be carried out in the maternity ward at Carmel Hospital. The study population
        will include patients who are about to undergo an elective caesarean section under spinal
        anesthesia. The recruitment will be done pre-surgery. Following consent, participants will
        receive an explanation about how to assess pain and will fill out the research
        questionnaires. Communication is the independent variable in this study , which has 2 levels
        - the increased communication arm and the normal communication arm. Each arm will include 40
        patients that will be randomly divided between the arms. The dependent variable is the
        treatment efficacy, based on the changes in the intensity of the patient's pain one hour
        after the administration of analgesic. The Self-Consciousness Scale (SCS-R) and the Short
        suggestibility scale (SSS) will be used to assess relevant personality traits.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Parallel design - subjects are allocated into one of two study arms
  primary purpose: Other
  masking: Double (Participant, Outcomes Assessor)
  masking description: At the time of analgesic request the nurse will open an envelop in which the participant assignment will be described. While the nurse (the communicator) is not blinded, the participants are blinded. The pain intensity reports will be recoded by the participants via a secured link, hence the participants are also the outcome assessor.
  measure: Change in pain intensity on the 0-10 pain scale
  time frame: one hour
  description: Change in pain intensity one hour following administration of analgesics
  measure: The Self-Consciousness Scale (SCS-R)
  time frame: Once, at baseline
  description: Assessment of direction of attention. Three variables are calculated (private and public attention and social anxiety)
  measure: The Short suggestibility scale (SSS)
  time frame: Once, at baseline
  description: Assessment of suggestibility score, ranging from 21 to 84, higher scores represent more tendency to suggestibility
  arm group label: Enhanced communication
  arm group type: Experimental
  description: In the enhanced communication study arm the nurse will say to the patient: "I will now give you our first line analgesic medication, liquid Dipyrone. It is a very efficient treatment and based on my experience you will very soon feel significant pain relief".
  arm group label: Normal communication
  arm group type: Other
  description: In the normal communication study arm the communication between the nurse and patients will be as usual in clinical practice - i.e. - no instruction are given to the nurses regarding on how to communicate with patients while administrating the treatment.
  intervention type: Behavioral
  intervention name: Communication style
  description: The verbal communication between the nurse and the patient at the time of analgesic administration
  arm group label: Enhanced communication
  arm group label: Normal communication
  criteria: 
  gender: Female
  gender based: Yes
  gender description: Only woman undergoing cesarian section
  minimum age: 18 Years
  maximum age: 50 Years
  healthy volunteers: No
  last name: Vered Cohen, BA
  role: Principal Investigator
  affiliation: Carmel Medical Center
  last name: Vered Cohen, BA
  phone: 972-525213440
  email: golanv35@walla.co.il
  facility: 
  status: Recruiting
  contact: 
  country: Israel
  responsible party type: Sponsor
  mesh term: Acute Pain
  sharing ipd: No
  ipd description: A link to the data location will be published in the article summarizing the results