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/NCT06017492</url>
    </required_header>
    <id_info>
      <org_study_id>PE in day surgery patients</org_study_id>
      <nct_id>NCT06017492</nct_id>
    </id_info>
    <brief_title>Effects of Video Use on Quality of Discharge Teaching and Patient Satisfaction in Day Surgery Patients</brief_title>
    <official_title>Effects of Video-assisted Discharge Education of Day Surgery Patients on the Perception of Quality of Discharge Teaching and Satisfaction With Nursing Care</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Near East University, Turkey</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Near East University, Turkey</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>
        this study is aimed to determine the effects of video-assisted discharge education of day&#xD;
        surgery patients on the perception of quality of discharge Study Hypothesis include the&#xD;
        following; H1: The day surgery patients who were exposed to the video-assisted discharge&#xD;
        educational intervention will have higher perception on quality of discharge teaching,&#xD;
        compared with those who were not exposed to the educational intervention.&#xD;
  &#xD;
        H2: The day surgery patients who were exposed to the video-assisted discharge educational&#xD;
        intervention will have enhanced satisfaction with nursing care quality, compared with those&#xD;
        who were not exposed to the educational intervention&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The goal of patient education in Daycare surgery is to improve overall patient outcome and&#xD;
        satisfaction. Comprehensive patient assessment, putting into consideration patient's needs&#xD;
        and expected postoperative difficulties, will help nurses in understanding types of patient&#xD;
        education strategies that can be used in order to promote better individualized quality&#xD;
        discharge education which in turn leads to the best postoperative outcomes (Quemby&amp; Stocker,&#xD;
        2014; Jaensson, Dahlberg &amp; Nilsson, 2019).&#xD;
  &#xD;
        Although there are various studies showing the effects of video assisted patient education,&#xD;
        there are only a few clinical studies concentrating on Day care Surgery patients and none in&#xD;
        Turkey. Therefore, we will examine the effect of video-assisted teaching in relation to&#xD;
        discharge planning, quality of nursing care and overall patient satisfaction in Day Care&#xD;
        Surgery patients' group. The result of this study may guide for development of the&#xD;
        educational strategies for Day Care Surgery patients.&#xD;
  &#xD;
        The study will be conducted in Jinepol Women's Health and IVF clinic in Turkey Jinepol.&#xD;
  &#xD;
        The study aims to recruit one hundred and seventy two (172) patients into the program. 86&#xD;
        participants will be selected in each group, using the simple random sampling method from&#xD;
        December 2022- December 2023&#xD;
  &#xD;
        Study tools:&#xD;
  &#xD;
        A descriptive data form, The Quality of Discharge Teaching Scale (QDTS) and Patient&#xD;
        Satisfaction with Nursing Care Quality Questionnaire (PSNCQQ) will be used in data&#xD;
        collection. The descriptive data form which will provide information about patients' gender,&#xD;
        nationality, age, type of surgery, educational level and occupation will be made by the&#xD;
        researcher. Ethical approval was obtained from Institutional Reviews Board (IRB) of Near East&#xD;
        University Hospital. In addition, informed consent from the patients and organizational&#xD;
        permission will be obtained. An institutional permission was obtained from the management of&#xD;
        Jinepol Women's Health and IVF Clinic. Since Permission has already been granted by the&#xD;
        authors of the Quality of Discharge Teaching Scale and the Patient Satisfaction with Nursing&#xD;
        Care Quality Questionnaire (PSNCQQ) to use the scales, no further permission will be&#xD;
        required.&#xD;
  &#xD;
        Statistical Package of SocialSciences (SPSS) software version 20.0 will be used to analyze&#xD;
        the collected data. Descriptive statistics (ie, means, standard deviations, and frequencies&#xD;
        and percentages) will be used to calculate for all patient characteristics and response&#xD;
        items. A chi-square test and independent T test will be used to determine the hypothesis&#xD;
        either null or alternate at a significant level of p &lt; 0.05.&#xD;
  &#xD;
        Evaluation of The Quality of Discharge Teaching Scale (QDTS) are as follows; 10: Excellent&#xD;
  &#xD;
        8 and 9 = very good&#xD;
  &#xD;
        6 and 7 = good&#xD;
  &#xD;
        5 = neutral&#xD;
  &#xD;
        3 and 4 = fair&#xD;
  &#xD;
        1 and 2 = poor&#xD;
  &#xD;
        0 = none/not at all&#xD;
  &#xD;
        The Mean of content and delivery subscales scores will be calculated separately.&#xD;
  &#xD;
        Evaluation of the Patient Satisfaction with Nursing Care Quality Questionnaire (PSNCQQ) are&#xD;
        as follow; 5 = Excellent&#xD;
  &#xD;
        4 = very good&#xD;
  &#xD;
        3 = good&#xD;
  &#xD;
        2 = fair&#xD;
  &#xD;
        1 = poor.&#xD;
  &#xD;
        The Mean and Standard deviation of items will be calculated&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">April 4, 2023</start_date>
    <completion_date type="Anticipated">December 2023</completion_date>
    <primary_completion_date type="Anticipated">December 2023</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>Eligible participants will be randomized in a one- to-one intervention allocation to the intervention (n = 86) or usual hospital method (n=86) group at the time of consent.</intervention_model_description>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>Allocation concealment will be blinded and performed in the order of recruitment using a computerized generated allocation method.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Effects of discharge education of day surgery patients on the perception of quality of discharge</measure>
      <time_frame>up to 2 days after day surgery procedure</time_frame>
      <description>effects of video assisted discharge education of day surgery patients on the perception of quality of discharge teaching as measured using the Quality of Discharge Teaching Scale (QDTS) by Marianne Weiss (weiss, 2022). the scale measures perception of patients' quality of discharge teaching which has been provided by nurses during the preparation for discharge. it is a 0 - 10 scale (0 = none, 10= Excellent), with higher scores reflecting a greater amount of information recieved and higher quality of discharge teaching</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Effects of discharge education of day surgery patients on Satisfaction with Nursing Care</measure>
      <time_frame>up to 2 days after day surgery procedure</time_frame>
      <description>The Patient Satisfaction with Nursing Care Quality Questionnaire 2005 (PSNCQQ) will be used to assess satisfaction of nursing care after day surgery. A 5- point Likert scale ranging from 'excellent' (5) to 'poor' (1) is used in each item of the Scale.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">172</enrollment>
    <condition>Patient Satisfaction</condition>
    <condition>Quality of Care</condition>
    <arm_group>
      <arm_group_label>Hospital Patient Education Method</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Control Group:&#xD;
  Implementation will be carried out in 2 phases; Phase 1(intervention): participants will receive hospital-based patient education method(printouts, verbal instruction). This intervention will be carried out in a 2 weeks period; starting 2 weeks before day surgery and ending after day surgery has been carried out.&#xD;
  Phase 2 (post test): In this part, participants will be asked to answer questions in the in the descriptive data, the Quality of Discharge Teaching Scale (QDTS) and Patient Satisfaction with Nursing Care Quality Questionnaire (PSNCQQ). The questionnaire will be printed and distributed to participants after Day Surgery. The questionnaire will also be in Google form format and sent to emails of participants who are not physically present at the clinic.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Audio-Visual Patient Education Method</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Implementation will be carried out in 2 phases; Phase 1(intervention): participants will recieve video assisted teaching as patient education method. Series of short videos will be played for the participants to watch and also sent to their phones through Whatsapp application or email. This intervention will be carried out in a 2 weeks period; starting 2 weeks before day Surgery and ending after day Surgery has been carried out.&#xD;
  Phase 2(post test): In this part, participants will be asked to answer questions in the in the descriptive data, the Quality of Discharge Teaching Scale (QDTS) and Patient Satisfaction with Nursing Care Quality Questionnaire (PSNCQQ). The questionnaire will be printed and distributed to participants after Day Surgery. The questionnaire will also be in Google form format and sent to emails of participants who are not physically present at the clinic.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>video assisted discharge teaching</intervention_name>
      <description>Patients will be educated using the video assisted discharge teaching. The educational content will be in English and will focus on the following topics: surgical process, medication use complication after surgery, pain management, wound care, nutrition, self-care after, surgery, home care after surgery and situations to refer to a physician.</description>
      <arm_group_label>Audio-Visual Patient Education Method</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Female patients, who understand English, have had day care surgery.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients less than 18 years of age&#xD;
  &#xD;
            -  Patients who do not understand or cannot read in English&#xD;
  &#xD;
            -  Patients with complications&#xD;
  &#xD;
            -  Patients who undergo surgery for oncological reasons&#xD;
  &#xD;
            -  Patients whose hospital stay was longer than 24 hours.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>55 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Sandra C Akire, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Near East University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Jinepol Women's Health and IVF Clinic</name>
        <address>
          <city>Levent</city>
          <state>Istanbul</state>
          <zip>34340</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Near East University, Turkey</investigator_affiliation>
      <investigator_full_name>Sandra Chirota Akire</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Day care surgery</keyword>
    <keyword>Patient education</keyword>
    <keyword>Discharge teaching</keyword>
    <keyword>video-assisted patient education</keyword>
    <keyword>Ambulatory surgery</keyword>
    <keyword>Nursing care</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT06017492
  org study id: PE in day surgery patients
  nct id: NCT06017492
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  this study is aimed to determine the effects of video-assisted discharge education of day
        surgery patients on the perception of quality of discharge Study Hypothesis include the
        following; H1: The day surgery patients who were exposed to the video-assisted discharge
        educational intervention will have higher perception on quality of discharge teaching,
        compared with those who were not exposed to the educational intervention.
  
        H2: The day surgery patients who were exposed to the video-assisted discharge educational
        intervention will have enhanced satisfaction with nursing care quality, compared with those
        who were not exposed to the educational intervention
  The goal of patient education in Daycare surgery is to improve overall patient outcome and
        satisfaction. Comprehensive patient assessment, putting into consideration patient's needs
        and expected postoperative difficulties, will help nurses in understanding types of patient
        education strategies that can be used in order to promote better individualized quality
        discharge education which in turn leads to the best postoperative outcomes (Quemby& Stocker,
        2014; Jaensson, Dahlberg & Nilsson, 2019).
  
        Although there are various studies showing the effects of video assisted patient education,
        there are only a few clinical studies concentrating on Day care Surgery patients and none in
        Turkey. Therefore, we will examine the effect of video-assisted teaching in relation to
        discharge planning, quality of nursing care and overall patient satisfaction in Day Care
        Surgery patients' group. The result of this study may guide for development of the
        educational strategies for Day Care Surgery patients.
  
        The study will be conducted in Jinepol Women's Health and IVF clinic in Turkey Jinepol.
  
        The study aims to recruit one hundred and seventy two (172) patients into the program. 86
        participants will be selected in each group, using the simple random sampling method from
        December 2022- December 2023
  
        Study tools:
  
        A descriptive data form, The Quality of Discharge Teaching Scale (QDTS) and Patient
        Satisfaction with Nursing Care Quality Questionnaire (PSNCQQ) will be used in data
        collection. The descriptive data form which will provide information about patients' gender,
        nationality, age, type of surgery, educational level and occupation will be made by the
        researcher. Ethical approval was obtained from Institutional Reviews Board (IRB) of Near East
        University Hospital. In addition, informed consent from the patients and organizational
        permission will be obtained. An institutional permission was obtained from the management of
        Jinepol Women's Health and IVF Clinic. Since Permission has already been granted by the
        authors of the Quality of Discharge Teaching Scale and the Patient Satisfaction with Nursing
        Care Quality Questionnaire (PSNCQQ) to use the scales, no further permission will be
        required.
  
        Statistical Package of SocialSciences (SPSS) software version 20.0 will be used to analyze
        the collected data. Descriptive statistics (ie, means, standard deviations, and frequencies
        and percentages) will be used to calculate for all patient characteristics and response
        items. A chi-square test and independent T test will be used to determine the hypothesis
        either null or alternate at a significant level of p < 0.05.
  
        Evaluation of The Quality of Discharge Teaching Scale (QDTS) are as follows; 10: Excellent
  
        8 and 9 = very good
  
        6 and 7 = good
  
        5 = neutral
  
        3 and 4 = fair
  
        1 and 2 = poor
  
        0 = none/not at all
  
        The Mean of content and delivery subscales scores will be calculated separately.
  
        Evaluation of the Patient Satisfaction with Nursing Care Quality Questionnaire (PSNCQQ) are
        as follow; 5 = Excellent
  
        4 = very good
  
        3 = good
  
        2 = fair
  
        1 = poor.
  
        The Mean and Standard deviation of items will be calculated
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Eligible participants will be randomized in a one- to-one intervention allocation to the intervention (n = 86) or usual hospital method (n=86) group at the time of consent.
  primary purpose: Health Services Research
  masking: Single (Participant)
  masking description: Allocation concealment will be blinded and performed in the order of recruitment using a computerized generated allocation method.
  measure: Effects of discharge education of day surgery patients on the perception of quality of discharge
  time frame: up to 2 days after day surgery procedure
  description: effects of video assisted discharge education of day surgery patients on the perception of quality of discharge teaching as measured using the Quality of Discharge Teaching Scale (QDTS) by Marianne Weiss (weiss, 2022). the scale measures perception of patients' quality of discharge teaching which has been provided by nurses during the preparation for discharge. it is a 0 - 10 scale (0 = none, 10= Excellent), with higher scores reflecting a greater amount of information recieved and higher quality of discharge teaching
  measure: Effects of discharge education of day surgery patients on Satisfaction with Nursing Care
  time frame: up to 2 days after day surgery procedure
  description: The Patient Satisfaction with Nursing Care Quality Questionnaire 2005 (PSNCQQ) will be used to assess satisfaction of nursing care after day surgery. A 5- point Likert scale ranging from 'excellent' (5) to 'poor' (1) is used in each item of the Scale.
  arm group label: Hospital Patient Education Method
  arm group type: No Intervention
  description: Control Group:
  Implementation will be carried out in 2 phases; Phase 1(intervention): participants will receive hospital-based patient education method(printouts, verbal instruction). This intervention will be carried out in a 2 weeks period; starting 2 weeks before day surgery and ending after day surgery has been carried out.
  Phase 2 (post test): In this part, participants will be asked to answer questions in the in the descriptive data, the Quality of Discharge Teaching Scale (QDTS) and Patient Satisfaction with Nursing Care Quality Questionnaire (PSNCQQ). The questionnaire will be printed and distributed to participants after Day Surgery. The questionnaire will also be in Google form format and sent to emails of participants who are not physically present at the clinic.
  arm group label: Audio-Visual Patient Education Method
  arm group type: Experimental
  description: Implementation will be carried out in 2 phases; Phase 1(intervention): participants will recieve video assisted teaching as patient education method. Series of short videos will be played for the participants to watch and also sent to their phones through Whatsapp application or email. This intervention will be carried out in a 2 weeks period; starting 2 weeks before day Surgery and ending after day Surgery has been carried out.
  Phase 2(post test): In this part, participants will be asked to answer questions in the in the descriptive data, the Quality of Discharge Teaching Scale (QDTS) and Patient Satisfaction with Nursing Care Quality Questionnaire (PSNCQQ). The questionnaire will be printed and distributed to participants after Day Surgery. The questionnaire will also be in Google form format and sent to emails of participants who are not physically present at the clinic.
  intervention type: Behavioral
  intervention name: video assisted discharge teaching
  description: Patients will be educated using the video assisted discharge teaching. The educational content will be in English and will focus on the following topics: surgical process, medication use complication after surgery, pain management, wound care, nutrition, self-care after, surgery, home care after surgery and situations to refer to a physician.
  arm group label: Audio-Visual Patient Education Method
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 55 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Sandra C Akire, PhD
  role: Principal Investigator
  affiliation: Near East University
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Near East University, Turkey
  investigator full name: Sandra Chirota Akire
  investigator title: Principal Investigator
  sharing ipd: No