<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/NCT03818464</url>
  </required_header>
  <id_info>
    <org_study_id>730/2018/OSS/AOUPR</org_study_id>
    <nct_id>NCT03818464</nct_id>
  </id_info>
  <brief_title>Psychological Assessment Before General Anesthesia (VeSPPA2018)</brief_title>
  <official_title>Pre-operative Psychological Assessment of Patients Undergoing General Anesthesia in Abdominal Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Parma</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Parma</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The level of preoperative anxiety can be related to the outcome of an operation and to the&#xD;
      post operative patient management .&#xD;
&#xD;
      The Dutch questionnaire APAIS (Amsterdam Preoperative Anxiety and Information Scale) is a&#xD;
      useful tool to quantify this parameter, and it has been translated and validated by the&#xD;
      University Federico II of Naples in the study &quot;Italian validation of the Amsterdam&#xD;
      Preoperative Anxiety and Information Scale&quot;.&#xD;
&#xD;
      The study aims at identifying the correlation between the preoperative anxiety level measured&#xD;
      by the APAIS in adult patients in general anesthesia undergoing elective major abdominal&#xD;
      surgery and the levels of post-operative pain measured by the VAS (Visual Analogue Scale) and&#xD;
      NRS (Numeric Rating Scale) scales.&#xD;
&#xD;
      Post-operative pain and agitation in the patient can be lessened through the objective&#xD;
      assessment of preoperative anxiety and its treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background and aim:&#xD;
&#xD;
      Anxiety is the body's physiological response to danger. It is a complex combination of&#xD;
      emotions and fear, which leads to developing the typical symptoms of the &quot;fight or flight&quot;&#xD;
      mode, as well as hyperactivity of the sympathetic nervous system which causes the body to&#xD;
      release the adrenal &quot;stress hormones&quot; (cortisol, noradrenaline and adrenaline).&#xD;
&#xD;
      Anxiety reaction is commonly experienced by patients undergoing surgeries, as these are&#xD;
      perceived as dangerous situations that cause the patient to feel powerless. Clinical practice&#xD;
      has shown that patients are concerned not only about the surgery itself but also about the&#xD;
      state of unconsciousness in which they enter because of general anesthesia. General&#xD;
      anesthesia is a medically induced coma which is temporary and reversible. It is obtained by&#xD;
      administering drugs to the patient, and it consists of three components - hypnosis, analgesia&#xD;
      and muscle relaxation.&#xD;
&#xD;
      The procedure can be broken down in the following phases:&#xD;
&#xD;
      medication - the patient is administered anxiolytic drugs.&#xD;
&#xD;
      Induction of general anesthesia - loss of consciousness and respiratory arrest; breathing&#xD;
      supported by mechanical ventilation.&#xD;
&#xD;
      Maintenance - surgery is carried out.&#xD;
&#xD;
      Emergence from anesthesia - administration of anesthetics is ceased and spontaneous breathing&#xD;
      resumes.&#xD;
&#xD;
      Anxious patients have hyperarousal of the sympathetic nervous system, which affects the&#xD;
      management of general anesthesia; with these patients, medication dosing will need to be&#xD;
      adjusted in order to counterbalance the hemodynamic and metabolic consequences caused by this&#xD;
      hyperarousal.&#xD;
&#xD;
      The following hypothesis is the aim of the study: to identify a significant number of&#xD;
      correlations between the preoperative anxiety levels (quantified by the APAIS questionnaire),&#xD;
      postoperative pain (quantified by the VAS and NRS scales), and the objective biological&#xD;
      parameters displayed in the crf.&#xD;
&#xD;
      Gathering such data precedes considering whether the modulation of preoperative anxiety can&#xD;
      affect positively the patient's outcome.&#xD;
&#xD;
      As a matter of fact, it is considered that reducing preoperative anxiety (for example through&#xD;
      doctor-patient conversation or administration of anxiolytic drugs) allows an improving of&#xD;
      postoperative physical and psychological conditions.&#xD;
&#xD;
      Medical literature on this topic shows that the preoperative anxiety level can be related to&#xD;
      the outcome of an operation and to the post-operative patient management. In 1996, the Dutch&#xD;
      Nelly Moerman, Martin J. Muller, F. S. van Dam and Hans Oosting introduced the Amsterdam&#xD;
      Preoperative Anxiety and Information Scale (APAIS) - a scale for the objective assessment of&#xD;
      anxiety.&#xD;
&#xD;
      It is a quick questionnaire consisting of 6 questions; its purpose is to investigate in&#xD;
      detail the patient's anxiety and his/her need of information about general anesthesia and the&#xD;
      surgery he/she will undergo. The questionnaire is easy to use and precise, which led to a&#xD;
      widespread use of the APAIS scale.&#xD;
&#xD;
      In Italy, the APAIS scale has been the subject matter of the study &quot;Italian validation of the&#xD;
      Amsterdam Preoperative Anxiety and Information Scale&quot; carried out by the the University&#xD;
      Federico II of Naples. This study demonstrated that the scale measured effectively the&#xD;
      preoperative anxiety level in that portion of Italian population undergoing surgery, and it&#xD;
      reliably identifies pathological anxiety. In fact, there are cases in which anxiety is not an&#xD;
      adaptive (thus physiological) response, but it reveals to be maladaptive (and thus&#xD;
      pathological). When present in the preoperative phase, this type of anxiety can strongly&#xD;
      affect a surgery's outcome.&#xD;
&#xD;
      The study aims at using the APAIS scale to measure preoperative anxiety levels in adult&#xD;
      patients in general anesthesia undergoing elective major abdominal surgery, and then assess&#xD;
      the correlation between the anxiety levels and the patient's wellbeing in the postoperative&#xD;
      phase. The investigators believes that the management of both surgery and patient's&#xD;
      postoperative pain can be improved through an objective assessment of preoperative anxiety&#xD;
      and its treatment. The questionnaire allows to obtain a certain score corresponding to a&#xD;
      certain level of anxiety in the patient (in the Italian translation of APAIS, the score &gt;14&#xD;
      corresponds to &quot;pathological anxiety&quot;). The work aims at identifying a significant number of&#xD;
      correlations between this score and the pain and between anxiety and the variation of&#xD;
      biological parameters displayed in the cfr (frequency, blood pressure, hemoglobin, and so&#xD;
      on).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 10, 2019</start_date>
  <completion_date type="Anticipated">March 10, 2021</completion_date>
  <primary_completion_date type="Anticipated">February 10, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Week</target_duration>
  <primary_outcome>
    <measure>Correlation between anxiety level and postoperative pain</measure>
    <time_frame>from before induction of general anesthesia until the end of recovery, up to 3 days</time_frame>
    <description>Identify the correlation between the preoperative patient anxiety level measured by APAIS (Amsterdam Preoperative Anxiety and Information Scale) and the postoperative pain levels measured using the VAS (Visual Analogue Scale). The evaluation range of Apais scale is from one (the lower level with better outcome) to five (the maximum level with worse outcome). The VAS Scale is made of six smiles from zero (the lower level with better outcome) to five ( the maximum level of pain with worse outcome).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Correlation between anxiety level and postoperative pain</measure>
    <time_frame>from before induction of general anesthesia until the end of recovery, up to 3 days</time_frame>
    <description>Identify the correlation between the preoperative patient anxiety level measured by APAIS (Amsterdam Preoperative Anxiety and Information Scale) and the postoperative pain levels measured using the NRS (Numeric Rating Scales). The evaluation range of Apais scale is from one (the lower level with better outcome) to five (the maximum level with worse outcome). The evaluation range of NRS scale is from zero ( the lower level with better outcome) to ten (the maximum level with worse outcome).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Level of agitation at the time of extubation</measure>
    <time_frame>from the time of extubation until the end of recovery, up to 3 days</time_frame>
    <description>Evaluate the level of agitation at the time of extubation through the BARS scale (Behavioral Activity Rating Scale). The evaluation range of the Bars scale is from one (the lower level with better outcome) to seven (the maximum level with worse outcome)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Level of agitation at the time of extubation</measure>
    <time_frame>from the time of extubation until the end of recovery, up to 3 days</time_frame>
    <description>Evaluate the level of agitation at the time of extubation through the RAMSAY Score (Ramsay Sedation Scale). The evaluation range of the Ramsay score is from one (the lower level with better outcome ) to six (the maximum level with worse outcome).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluate treatment of anxiety</measure>
    <time_frame>from the time of awakening until the end of recovery, up to 3 days</time_frame>
    <description>Pre-operative anxiety will be evaluated through APAIS (Amsterdam Preoperative Anxiety and Information Scale) questionnaire, for set the optimal type and dosage (mg/Kg) of drugs given for anxiety treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate treatment of pain</measure>
    <time_frame>from the time of awakening until the end of recovery, up to 3 days</time_frame>
    <description>Post operative pain will be evaluated through VAS (Visual Analogue Scale) score, for set the optimal type and dosage (mg/Kg) of drugs given for pain treatment.&#xD;
The VAS Scale is made of six smiles from zero (the lower level with better outcome) to five ( the maximum level of pain with worse outcome).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate treatment of pain</measure>
    <time_frame>from the time of awakening until the end of recovery, up to 3 days</time_frame>
    <description>Post operative pain will be evaluated through NRS (Numeric Rating Scale) score, for set the optimal type and dosage (mg/Kg) of drugs given for pain treatment. The evaluation range of NRS scale is from zero ( the lower level with better outcome) to ten (the maximum level with worse outcome).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's emotional background</measure>
    <time_frame>from the time of awakening until the end of recovery, up to 3 days</time_frame>
    <description>To investigate the patient's emotional background on the experience of general anesthesia through post-operative interviews</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neoplastic patient</measure>
    <time_frame>from the time of awakening until the end of recovery, up to 3 days</time_frame>
    <description>Evaluate the presence of any APAIS (Amsterdam Preoperative Anxiety and Information Scale) score differences in patients with and without neoplasia. The evaluation range of Apais scale is from one (the lower level with better outcome) to five (the maximum level with worse outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative complications</measure>
    <time_frame>from the time of awakening until the end of recovery, up to 3 days</time_frame>
    <description>Evaluate the incidence of postoperative complications such as hypoxia, correlating the APAIS (Amsterdam Preoperative Anxiety and Information Scale) score in the preoperative with the values of arterial pressure, heart rate, oxygen saturation, hemoglobin and hematocrit in the postoperative</description>
  </secondary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Anesthesia</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Non-critically ill patients undergoing general anesthesia before elective surgery.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patient aged between 18 and 75 years.&#xD;
&#xD;
          -  Degrees I, II and III of the ASA Classification (Classification of the physical&#xD;
             condition of the patient).&#xD;
&#xD;
          -  Patients under general anesthesia for major abdominal surgery in election.&#xD;
&#xD;
          -  Adult aware and informed that he has signed the informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient who refuses to sign informed consent.&#xD;
&#xD;
          -  Patient under general anesthesia for emergency surgery.&#xD;
&#xD;
          -  Patient with an established diagnosis and / or in therapy for serious diseases of the&#xD;
             emotional sphere, major depression or severe psychosis.&#xD;
&#xD;
          -  Patient with history of drug addiction and / or alcohol abuse.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Raffaella Troglio, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Azienda Ospedaliero-Universitaria di Parma</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Andrea Bonetti, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Azienda Ospedaliero-Universitaria di Parma</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mirko Bottari, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Azienda Ospedaliero-Universitaria di Parma</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Federica Cassè, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Azienda Ospedaliero-Universitaria di Parma</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Federica Causo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Azienda Ospedaliero-Universitaria di Parma</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jessica Colla, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Azienda Ospedaliero-Universitaria di Parma</affiliation>
  </overall_official>
  <overall_official>
    <last_name>PierCarlo Cottone, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Azienda Ospedaliero-Universitaria di Parma</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Marco DiLecce, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Azienda Ospedaliero-Universitaria di Parma</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Giovanni Gasbarro, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Azienda Ospedaliero-Universitaria di Parma</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Gelinda Giadone, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Azienda Ospedaliero-Universitaria di Parma</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Valentina Giampaoli, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Azienda Ospedaliero-Universitaria di Parma</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Filippo Grandini, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Azienda Ospedaliero-Universitaria di Parma</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Vera Gualeni, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Azienda Ospedaliero-Universitaria di Parma</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Alberto Iori, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Azienda Ospedaliero-Universitaria di Parma</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Marcello LaBombarda, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Azienda Ospedaliero-Universitaria di Parma</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Cristina Madoni, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Azienda Ospedaliero-Universitaria di Parma</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Benedetta Marziani, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Azienda Ospedaliero-Universitaria di Parma</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Cristina Piccinini, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Azienda Ospedaliero-Universitaria di Parma</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Elena Giovanna Bignami, Professor of Anesthesiology</last_name>
    <phone>+3905211033609</phone>
    <email>elenagiovanna.bignami@unipr.it</email>
  </overall_contact>
  <location>
    <facility>
      <name>Azienda Ospedaliero-Universitaria di Parma</name>
      <address>
        <city>Parma</city>
        <state>Italy (pr)</state>
        <zip>43126</zip>
        <country>Italy</country>
      </address>
    </facility>
    <contact>
      <last_name>Elena Giovanna Bignami, MD Professor</last_name>
      <phone>+3905211033609</phone>
      <email>elenagiovanna.bignami@unipr.it</email>
    </contact>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 21, 2019</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>January 28, 2019</last_update_submitted>
  <last_update_submitted_qc>January 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Parma</investigator_affiliation>
    <investigator_full_name>Elena Giovanna Bignami</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>pre-operative assessment</keyword>
  <keyword>postoperative pain</keyword>
  <keyword>biological complications</keyword>
  <!-- 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/NCT03818464
org study id: 730/2018/OSS/AOUPR
nct id: NCT03818464
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The level of preoperative anxiety can be related to the outcome of an operation and to the
      post operative patient management .

      The Dutch questionnaire APAIS (Amsterdam Preoperative Anxiety and Information Scale) is a
      useful tool to quantify this parameter, and it has been translated and validated by the
      University Federico II of Naples in the study "Italian validation of the Amsterdam
      Preoperative Anxiety and Information Scale".

      The study aims at identifying the correlation between the preoperative anxiety level measured
      by the APAIS in adult patients in general anesthesia undergoing elective major abdominal
      surgery and the levels of post-operative pain measured by the VAS (Visual Analogue Scale) and
      NRS (Numeric Rating Scale) scales.

      Post-operative pain and agitation in the patient can be lessened through the objective
      assessment of preoperative anxiety and its treatment.
Background and aim:

      Anxiety is the body's physiological response to danger. It is a complex combination of
      emotions and fear, which leads to developing the typical symptoms of the "fight or flight"
      mode, as well as hyperactivity of the sympathetic nervous system which causes the body to
      release the adrenal "stress hormones" (cortisol, noradrenaline and adrenaline).

      Anxiety reaction is commonly experienced by patients undergoing surgeries, as these are
      perceived as dangerous situations that cause the patient to feel powerless. Clinical practice
      has shown that patients are concerned not only about the surgery itself but also about the
      state of unconsciousness in which they enter because of general anesthesia. General
      anesthesia is a medically induced coma which is temporary and reversible. It is obtained by
      administering drugs to the patient, and it consists of three components - hypnosis, analgesia
      and muscle relaxation.

      The procedure can be broken down in the following phases:

      medication - the patient is administered anxiolytic drugs.

      Induction of general anesthesia - loss of consciousness and respiratory arrest; breathing
      supported by mechanical ventilation.

      Maintenance - surgery is carried out.

      Emergence from anesthesia - administration of anesthetics is ceased and spontaneous breathing
      resumes.

      Anxious patients have hyperarousal of the sympathetic nervous system, which affects the
      management of general anesthesia; with these patients, medication dosing will need to be
      adjusted in order to counterbalance the hemodynamic and metabolic consequences caused by this
      hyperarousal.

      The following hypothesis is the aim of the study: to identify a significant number of
      correlations between the preoperative anxiety levels (quantified by the APAIS questionnaire),
      postoperative pain (quantified by the VAS and NRS scales), and the objective biological
      parameters displayed in the crf.

      Gathering such data precedes considering whether the modulation of preoperative anxiety can
      affect positively the patient's outcome.

      As a matter of fact, it is considered that reducing preoperative anxiety (for example through
      doctor-patient conversation or administration of anxiolytic drugs) allows an improving of
      postoperative physical and psychological conditions.

      Medical literature on this topic shows that the preoperative anxiety level can be related to
      the outcome of an operation and to the post-operative patient management. In 1996, the Dutch
      Nelly Moerman, Martin J. Muller, F. S. van Dam and Hans Oosting introduced the Amsterdam
      Preoperative Anxiety and Information Scale (APAIS) - a scale for the objective assessment of
      anxiety.

      It is a quick questionnaire consisting of 6 questions; its purpose is to investigate in
      detail the patient's anxiety and his/her need of information about general anesthesia and the
      surgery he/she will undergo. The questionnaire is easy to use and precise, which led to a
      widespread use of the APAIS scale.

      In Italy, the APAIS scale has been the subject matter of the study "Italian validation of the
      Amsterdam Preoperative Anxiety and Information Scale" carried out by the the University
      Federico II of Naples. This study demonstrated that the scale measured effectively the
      preoperative anxiety level in that portion of Italian population undergoing surgery, and it
      reliably identifies pathological anxiety. In fact, there are cases in which anxiety is not an
      adaptive (thus physiological) response, but it reveals to be maladaptive (and thus
      pathological). When present in the preoperative phase, this type of anxiety can strongly
      affect a surgery's outcome.

      The study aims at using the APAIS scale to measure preoperative anxiety levels in adult
      patients in general anesthesia undergoing elective major abdominal surgery, and then assess
      the correlation between the anxiety levels and the patient's wellbeing in the postoperative
      phase. The investigators believes that the management of both surgery and patient's
      postoperative pain can be improved through an objective assessment of preoperative anxiety
      and its treatment. The questionnaire allows to obtain a certain score corresponding to a
      certain level of anxiety in the patient (in the Italian translation of APAIS, the score >14
      corresponds to "pathological anxiety"). The work aims at identifying a significant number of
      correlations between this score and the pain and between anxiety and the variation of
      biological parameters displayed in the cfr (frequency, blood pressure, hemoglobin, and so
      on).
observational model: Cohort
time perspective: Prospective
measure: Correlation between anxiety level and postoperative pain
time frame: from before induction of general anesthesia until the end of recovery, up to 3 days
description: Identify the correlation between the preoperative patient anxiety level measured by APAIS (Amsterdam Preoperative Anxiety and Information Scale) and the postoperative pain levels measured using the VAS (Visual Analogue Scale). The evaluation range of Apais scale is from one (the lower level with better outcome) to five (the maximum level with worse outcome). The VAS Scale is made of six smiles from zero (the lower level with better outcome) to five ( the maximum level of pain with worse outcome).
measure: Correlation between anxiety level and postoperative pain
time frame: from before induction of general anesthesia until the end of recovery, up to 3 days
description: Identify the correlation between the preoperative patient anxiety level measured by APAIS (Amsterdam Preoperative Anxiety and Information Scale) and the postoperative pain levels measured using the NRS (Numeric Rating Scales). The evaluation range of Apais scale is from one (the lower level with better outcome) to five (the maximum level with worse outcome). The evaluation range of NRS scale is from zero ( the lower level with better outcome) to ten (the maximum level with worse outcome).
measure: Level of agitation at the time of extubation
time frame: from the time of extubation until the end of recovery, up to 3 days
description: Evaluate the level of agitation at the time of extubation through the BARS scale (Behavioral Activity Rating Scale). The evaluation range of the Bars scale is from one (the lower level with better outcome) to seven (the maximum level with worse outcome)
measure: Level of agitation at the time of extubation
time frame: from the time of extubation until the end of recovery, up to 3 days
description: Evaluate the level of agitation at the time of extubation through the RAMSAY Score (Ramsay Sedation Scale). The evaluation range of the Ramsay score is from one (the lower level with better outcome ) to six (the maximum level with worse outcome).
measure: Evaluate treatment of anxiety
time frame: from the time of awakening until the end of recovery, up to 3 days
description: Pre-operative anxiety will be evaluated through APAIS (Amsterdam Preoperative Anxiety and Information Scale) questionnaire, for set the optimal type and dosage (mg/Kg) of drugs given for anxiety treatment.
measure: Evaluate treatment of pain
time frame: from the time of awakening until the end of recovery, up to 3 days
description: Post operative pain will be evaluated through VAS (Visual Analogue Scale) score, for set the optimal type and dosage (mg/Kg) of drugs given for pain treatment.
The VAS Scale is made of six smiles from zero (the lower level with better outcome) to five ( the maximum level of pain with worse outcome).
measure: Evaluate treatment of pain
time frame: from the time of awakening until the end of recovery, up to 3 days
description: Post operative pain will be evaluated through NRS (Numeric Rating Scale) score, for set the optimal type and dosage (mg/Kg) of drugs given for pain treatment. The evaluation range of NRS scale is from zero ( the lower level with better outcome) to ten (the maximum level with worse outcome).
measure: Patient's emotional background
time frame: from the time of awakening until the end of recovery, up to 3 days
description: To investigate the patient's emotional background on the experience of general anesthesia through post-operative interviews
measure: Neoplastic patient
time frame: from the time of awakening until the end of recovery, up to 3 days
description: Evaluate the presence of any APAIS (Amsterdam Preoperative Anxiety and Information Scale) score differences in patients with and without neoplasia. The evaluation range of Apais scale is from one (the lower level with better outcome) to five (the maximum level with worse outcome)
measure: Postoperative complications
time frame: from the time of awakening until the end of recovery, up to 3 days
description: Evaluate the incidence of postoperative complications such as hypoxia, correlating the APAIS (Amsterdam Preoperative Anxiety and Information Scale) score in the preoperative with the values of arterial pressure, heart rate, oxygen saturation, hemoglobin and hematocrit in the postoperative
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Raffaella Troglio, MD
role: Principal Investigator
affiliation: Azienda Ospedaliero-Universitaria di Parma
last name: Andrea Bonetti, MD
role: Principal Investigator
affiliation: Azienda Ospedaliero-Universitaria di Parma
last name: Mirko Bottari, MD
role: Principal Investigator
affiliation: Azienda Ospedaliero-Universitaria di Parma
last name: Federica Cassè, MD
role: Principal Investigator
affiliation: Azienda Ospedaliero-Universitaria di Parma
last name: Federica Causo, MD
role: Principal Investigator
affiliation: Azienda Ospedaliero-Universitaria di Parma
last name: Jessica Colla, MD
role: Principal Investigator
affiliation: Azienda Ospedaliero-Universitaria di Parma
last name: PierCarlo Cottone, MD
role: Principal Investigator
affiliation: Azienda Ospedaliero-Universitaria di Parma
last name: Marco DiLecce, MD
role: Principal Investigator
affiliation: Azienda Ospedaliero-Universitaria di Parma
last name: Giovanni Gasbarro, MD
role: Principal Investigator
affiliation: Azienda Ospedaliero-Universitaria di Parma
last name: Gelinda Giadone, MD
role: Principal Investigator
affiliation: Azienda Ospedaliero-Universitaria di Parma
last name: Valentina Giampaoli, MD
role: Principal Investigator
affiliation: Azienda Ospedaliero-Universitaria di Parma
last name: Filippo Grandini, MD
role: Principal Investigator
affiliation: Azienda Ospedaliero-Universitaria di Parma
last name: Vera Gualeni, MD
role: Principal Investigator
affiliation: Azienda Ospedaliero-Universitaria di Parma
last name: Alberto Iori, MD
role: Principal Investigator
affiliation: Azienda Ospedaliero-Universitaria di Parma
last name: Marcello LaBombarda, MD
role: Principal Investigator
affiliation: Azienda Ospedaliero-Universitaria di Parma
last name: Cristina Madoni, MD
role: Principal Investigator
affiliation: Azienda Ospedaliero-Universitaria di Parma
last name: Benedetta Marziani, MD
role: Principal Investigator
affiliation: Azienda Ospedaliero-Universitaria di Parma
last name: Cristina Piccinini, MD
role: Principal Investigator
affiliation: Azienda Ospedaliero-Universitaria di Parma
last name: Elena Giovanna Bignami, Professor of Anesthesiology
phone: +3905211033609
email: elenagiovanna.bignami@unipr.it
facility: 
contact: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: University of Parma
investigator full name: Elena Giovanna Bignami
investigator title: Clinical Professor