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/NCT05974956</url>
    </required_header>
    <id_info>
      <org_study_id>Mastitis prognosis</org_study_id>
      <nct_id>NCT05974956</nct_id>
    </id_info>
    <brief_title>Effect of a Nursing Teaching Protocol on Mastitis Prognosis: Quasi-Experimental Research Design</brief_title>
    <acronym>Mastitis</acronym>
    <official_title>Effect of a Nursing Teaching Protocol on Mastitis Prognosis: Quasi-Experimental Research Design</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Assiut University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Assiut University</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>
        Aim: Evaluate the effect of a nursing teaching protocol on mastitis prognosis. Research&#xD;
        design: Quasi-experimental research design was utilized. A convenient sample of sixty adult&#xD;
        female patients diagnosed with mastitis, Patients divided equally into two groups(study and&#xD;
        control) thirty for each.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study was conducted in the breast unit in general surgery department at Main Assiut&#xD;
        University Hospital. A convenient sample of sixty adult female patients diagnosed with&#xD;
        mastitis, their ages range from 20 to 65years old. Patients divided equally into two groups;&#xD;
        thirty for each. Both groups had been assessed at base line using the following tools:&#xD;
  &#xD;
        Tool (I): An interview questionnaire sheet Tool (II):Mastitis self-care practices Tool (III):&#xD;
        Numeric pain rating scale Tool (IV): Mastitis prognosis sheet&#xD;
  &#xD;
        The control group exposed to routine care and study group received mastitis teaching&#xD;
        protocol. After three weeks; both groups had been reassessed by the same tools.&#xD;
  &#xD;
        Data analysis had been performed by using the Statistical Package for the Social Sciences&#xD;
        (SPSS) Categorical variables described by number and percent (N, %). Continuous variables&#xD;
        described by mean and standard deviation (Mean, SD). Chi-square test and Fisher exact test&#xD;
        used to compare between categorical variables .T-test and Pearson's chi-square used to appear&#xD;
        the association between patients' knowledge, practice, and mastitis prognosis before&#xD;
        implementation of nursing teaching protocol and three weeks post.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">April 1, 2022</start_date>
    <completion_date type="Actual">April 30, 2023</completion_date>
    <primary_completion_date type="Actual">November 30, 2022</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Quasi experimental research design that test for change through manipulation of the independent variable. However, in this study, it lacks one of the three key properties of an experimental design &quot;randomization&quot;.&#xD;
  The dependent variables (mastitis knowledge, self -care practice, pain level, and complications associated with mastitis) were measured and compared at base line for both control and study groups, then intervention was introduced to the study group. After three weeks; the dependent variables for both groups were evaluated to test the difference.</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>Medical researcher &quot;N&quot; assessed the prognosis of mastitis using tool IV&quot; mastitis prognosis sheet for all patients &quot;control - study&quot; at follow up without knowing the study group who received the nursing teaching protocol</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Compare the difference between the mean knowledge of participants (study and control groups) regarding mastitis care and management at base line &amp; follow up after three weeks.</measure>
      <time_frame>Base line assessment: Is the first assessment --------- Follow up assessment:: after three weeks</time_frame>
      <description>The knowledge of participants(study and control groups) regarding mastitis care and management had been assessed twice( base line - follow up) using: Tool I: An interview questionnaire sheet (part 2)&#xD;
  Tool I: It was structured by authors and reviewed by a panel of experts in General Surgery and Medical -Surgical Nursing.&#xD;
  Each answered question scored from 0 to 3 marks as follows; 3 marks for complete correct answer, 2 marks for incomplete correct answer, 1 mark for incorrect answer and zero for not known answer.&#xD;
  The range of total score lies between 0-30, the scoring system interpreted in the results into satisfactory and unsatisfactory; satisfactory: if the total knowledge score is ≥ 60% and unsatisfactory if the total knowledge score is &lt; 60%.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Compare the difference between the mean practice of participants (study and control groups) regarding mastitis care and management at base line &amp; follow up after three weeks.</measure>
      <time_frame>Base line assessment: Is the first assessment --------- Follow up assessment:: after three weeks</time_frame>
      <description>The performance of participants (study and control groups) regarding mastitis care and management had been assessed twice (baseline- follow up) using: Tool II: &quot;Mastitis self-care practices&quot;.&#xD;
  Tool II: It was structured by authors and reviewed by a panel of experts in General Surgery and Medical -Surgical Nursing.&#xD;
  Scoring:&#xD;
  A total score of 60% or higher considered as adequate self-care practices and less than 60% considered as inadequate. Three points scale used to grade the steps. Two points for doing correctly. One point for doing incorrectly and zero point for not doing at all.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Pain level using Numeric Pain Rating scale</measure>
      <time_frame>Base line assessment: Is the first assessment --------- Follow up assessment:: after three weeks</time_frame>
      <description>Pain level as a symptom of mastitis was measured at base line using Tool III: Numeric Pain rating scale for both study and control groups.&#xD;
  It was asked from each patient to rate pain level from 0 to10 with understanding that 0 is equal to no pain and 10 is equal to worst possible pain.&#xD;
  At follow up &quot;third week&quot; pain level was measured again for both study and control groups with the same scale to test for change.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants(study -control) who discontinued breast feeding</measure>
      <time_frame>At the third week from base line assessment.</time_frame>
      <description>Lactating women in either groups (study -control) reported that they discontinued nursing their babies.&#xD;
  This outcome was evaluated by using tool IV: &quot;Mastitis prognosis sheet&quot; that had been structured by authors and reviewed by a panel of experts in General Surgery and Medical -Surgical Nursing.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants (study -control) who completely cured from mastitis</measure>
      <time_frame>At the third week from base line assessment.</time_frame>
      <description>Inflamed breast was evaluated for both groups (study- control), If it resolved and returned to normal condition or not.&#xD;
  This outcome was evaluated clinically (signs &amp; symptoms) by using tool IV: &quot;Mastitis prognosis sheet&quot; that had been structured by authors and reviewed by a panel of experts in General Surgery and Medical -Surgical Nursing.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants (study -control) who their condition complicated with formation of breast abscess.</measure>
      <time_frame>At the third week from base line assessment.</time_frame>
      <description>Breast abscess is a complication of mastitis that will be formed within the inflamed breast tissue.&#xD;
  This outcome was evaluated clinically (signs and symptoms) by using tool IV: &quot;Mastitis prognosis sheet&quot; that had been structured by authors and reviewed by a panel of experts in General Surgery and Medical -Surgical Nursing.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of mastitis recurrence among participants(study -control) .</measure>
      <time_frame>At the third week from base line assessment.</time_frame>
      <description>The inflamed breast tissue re-inflamed again for the second time.&#xD;
  This outcome was evaluated clinically (signs and symptoms) by using tool IV: &quot;Mastitis prognosis sheet&quot; that had been structured by authors and reviewed by a panel of experts in General Surgery and Medical -Surgical Nursing.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">60</enrollment>
    <condition>Mastitis</condition>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>The control group exposed to routine care.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Study group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The study group received the sessions of &quot;mastitis care teaching protocol&quot;.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Mastitis care teaching protocol</intervention_name>
      <description>It was developed by the authors based on previous similar studies, articles and library resources. It was introduced to the study group in the form of face to face sessions plus a hand out copy. It consisted of three parts; (1): Theoretical part about mastitis (definition, types, clinical manifestation, possible causes, diagnosis and management). (2):Self-care practices, and (3):Recommendations regarding dietary measures, rest, medication and follow up.</description>
      <arm_group_label>Study group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Exclusion Criteria:&#xD;
  &#xD;
            1. Mental health problems&#xD;
  &#xD;
            2. Visual or hearing problems&#xD;
  &#xD;
            3. Uncooperative&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Inclusion criteria:&#xD;
  Adult women&#xD;
  Age from 20 to 65 yrs.&#xD;
  Clinical diagnosis of mastitis&#xD;
  Lactational or non-lactational mastitis</gender_description>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Faculty of Nursing</name>
        <address>
          <city>Assiut</city>
          <zip>71111</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 2, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Assiut University</investigator_affiliation>
      <investigator_full_name>Amna A. Desouky, MD</investigator_full_name>
      <investigator_title>Assistant professor of Medical Surgical Nursing</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Mastitis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Yes: There is a plan to make IPD and related data dictionaries available.</ipd_description>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    </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/NCT05974956
  org study id: Mastitis prognosis
  nct id: NCT05974956
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Aim: Evaluate the effect of a nursing teaching protocol on mastitis prognosis. Research
        design: Quasi-experimental research design was utilized. A convenient sample of sixty adult
        female patients diagnosed with mastitis, Patients divided equally into two groups(study and
        control) thirty for each.
  The study was conducted in the breast unit in general surgery department at Main Assiut
        University Hospital. A convenient sample of sixty adult female patients diagnosed with
        mastitis, their ages range from 20 to 65years old. Patients divided equally into two groups;
        thirty for each. Both groups had been assessed at base line using the following tools:
  
        Tool (I): An interview questionnaire sheet Tool (II):Mastitis self-care practices Tool (III):
        Numeric pain rating scale Tool (IV): Mastitis prognosis sheet
  
        The control group exposed to routine care and study group received mastitis teaching
        protocol. After three weeks; both groups had been reassessed by the same tools.
  
        Data analysis had been performed by using the Statistical Package for the Social Sciences
        (SPSS) Categorical variables described by number and percent (N, %). Continuous variables
        described by mean and standard deviation (Mean, SD). Chi-square test and Fisher exact test
        used to compare between categorical variables .T-test and Pearson's chi-square used to appear
        the association between patients' knowledge, practice, and mastitis prognosis before
        implementation of nursing teaching protocol and three weeks post.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  intervention model description: Quasi experimental research design that test for change through manipulation of the independent variable. However, in this study, it lacks one of the three key properties of an experimental design "randomization".
  The dependent variables (mastitis knowledge, self -care practice, pain level, and complications associated with mastitis) were measured and compared at base line for both control and study groups, then intervention was introduced to the study group. After three weeks; the dependent variables for both groups were evaluated to test the difference.
  primary purpose: Prevention
  masking: Single (Outcomes Assessor)
  masking description: Medical researcher "N" assessed the prognosis of mastitis using tool IV" mastitis prognosis sheet for all patients "control - study" at follow up without knowing the study group who received the nursing teaching protocol
  measure: Compare the difference between the mean knowledge of participants (study and control groups) regarding mastitis care and management at base line & follow up after three weeks.
  time frame: Base line assessment: Is the first assessment --------- Follow up assessment:: after three weeks
  description: The knowledge of participants(study and control groups) regarding mastitis care and management had been assessed twice( base line - follow up) using: Tool I: An interview questionnaire sheet (part 2)
  Tool I: It was structured by authors and reviewed by a panel of experts in General Surgery and Medical -Surgical Nursing.
  Each answered question scored from 0 to 3 marks as follows; 3 marks for complete correct answer, 2 marks for incomplete correct answer, 1 mark for incorrect answer and zero for not known answer.
  The range of total score lies between 0-30, the scoring system interpreted in the results into satisfactory and unsatisfactory; satisfactory: if the total knowledge score is ≥ 60% and unsatisfactory if the total knowledge score is < 60%.
  measure: Compare the difference between the mean practice of participants (study and control groups) regarding mastitis care and management at base line & follow up after three weeks.
  time frame: Base line assessment: Is the first assessment --------- Follow up assessment:: after three weeks
  description: The performance of participants (study and control groups) regarding mastitis care and management had been assessed twice (baseline- follow up) using: Tool II: "Mastitis self-care practices".
  Tool II: It was structured by authors and reviewed by a panel of experts in General Surgery and Medical -Surgical Nursing.
  Scoring:
  A total score of 60% or higher considered as adequate self-care practices and less than 60% considered as inadequate. Three points scale used to grade the steps. Two points for doing correctly. One point for doing incorrectly and zero point for not doing at all.
  measure: Pain level using Numeric Pain Rating scale
  time frame: Base line assessment: Is the first assessment --------- Follow up assessment:: after three weeks
  description: Pain level as a symptom of mastitis was measured at base line using Tool III: Numeric Pain rating scale for both study and control groups.
  It was asked from each patient to rate pain level from 0 to10 with understanding that 0 is equal to no pain and 10 is equal to worst possible pain.
  At follow up "third week" pain level was measured again for both study and control groups with the same scale to test for change.
  measure: Number of participants(study -control) who discontinued breast feeding
  time frame: At the third week from base line assessment.
  description: Lactating women in either groups (study -control) reported that they discontinued nursing their babies.
  This outcome was evaluated by using tool IV: "Mastitis prognosis sheet" that had been structured by authors and reviewed by a panel of experts in General Surgery and Medical -Surgical Nursing.
  measure: Number of participants (study -control) who completely cured from mastitis
  time frame: At the third week from base line assessment.
  description: Inflamed breast was evaluated for both groups (study- control), If it resolved and returned to normal condition or not.
  This outcome was evaluated clinically (signs & symptoms) by using tool IV: "Mastitis prognosis sheet" that had been structured by authors and reviewed by a panel of experts in General Surgery and Medical -Surgical Nursing.
  measure: Number of participants (study -control) who their condition complicated with formation of breast abscess.
  time frame: At the third week from base line assessment.
  description: Breast abscess is a complication of mastitis that will be formed within the inflamed breast tissue.
  This outcome was evaluated clinically (signs and symptoms) by using tool IV: "Mastitis prognosis sheet" that had been structured by authors and reviewed by a panel of experts in General Surgery and Medical -Surgical Nursing.
  measure: Number of mastitis recurrence among participants(study -control) .
  time frame: At the third week from base line assessment.
  description: The inflamed breast tissue re-inflamed again for the second time.
  This outcome was evaluated clinically (signs and symptoms) by using tool IV: "Mastitis prognosis sheet" that had been structured by authors and reviewed by a panel of experts in General Surgery and Medical -Surgical Nursing.
  arm group label: Control group
  arm group type: No Intervention
  description: The control group exposed to routine care.
  arm group label: Study group
  arm group type: Experimental
  description: The study group received the sessions of "mastitis care teaching protocol".
  intervention type: Other
  intervention name: Mastitis care teaching protocol
  description: It was developed by the authors based on previous similar studies, articles and library resources. It was introduced to the study group in the form of face to face sessions plus a hand out copy. It consisted of three parts; (1): Theoretical part about mastitis (definition, types, clinical manifestation, possible causes, diagnosis and management). (2):Self-care practices, and (3):Recommendations regarding dietary measures, rest, medication and follow up.
  arm group label: Study group
  criteria: 
  gender: Female
  gender based: Yes
  gender description: Inclusion criteria:
  Adult women
  Age from 20 to 65 yrs.
  Clinical diagnosis of mastitis
  Lactational or non-lactational mastitis
  minimum age: 20 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Assiut University
  investigator full name: Amna A. Desouky, MD
  investigator title: Assistant professor of Medical Surgical Nursing
  mesh term: Mastitis
  sharing ipd: Yes
  ipd description: Yes: There is a plan to make IPD and related data dictionaries available.
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Clinical Study Report (CSR)