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/NCT06013826</url>
    </required_header>
    <id_info>
      <org_study_id>2021/0650</org_study_id>
      <nct_id>NCT06013826</nct_id>
    </id_info>
    <brief_title>The Effect of Telenursing on the Pain and Fear of Insulin Injection</brief_title>
    <official_title>University of Health Sciences, Hamidiye Faculty of Nursing</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Istanbul Saglik Bilimleri University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Istanbul Saglik Bilimleri University</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>
        Aim: The aim of the study is to examine the effects of nursing follow-up with telenursing on&#xD;
        the pain and fear factors related to self-injection testing in diabetic individuals who are&#xD;
        started on insulin therapy for the first time.&#xD;
  &#xD;
        Materials and Methods: The research was implemented in a randomized controlled experimental&#xD;
        design. The sample consisted of 70 individuals with diabetes who started insulin therapy for&#xD;
        the first time in the diabetes polyclinic of a state university hospital in Istanbul between&#xD;
        17 February and 15 November 2022. Individuals who will start insulin therapy for the first&#xD;
        time are directed to the diabetes polyclinic. Insulin Injection Application to all patients&#xD;
        in the diabetes polyclinic. In line with the Patient Education Content, the ability to&#xD;
        administer insulin, the ability to monitor blood glucose levels, medical nutrition therapy,&#xD;
        exercise, etc. applied after the training given on the subjects. Data were collected with the&#xD;
        Patient Information Form, Diabetic Self-Injection and Fear of Testing Questionnaire Form&#xD;
        (D-SFIQ), Insulin Injection Evaluation Form. Patients assigned to the intervention group were&#xD;
        given telehealth service for three days for fear of self-injection and testing.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The sample of the study consisted of 70 patients who met the inclusion criteria and agreed to&#xD;
        participate. Insulin therapy was evaluated according to the inclusion criteria and those who&#xD;
        agreed to participate in the study. 19 doctors and 2 nurses work in the diabetes polyclinic.&#xD;
        Individuals who will start insulin therapy for the first time after a doctor's examination&#xD;
        are referred to the diabetes polyclinic. The history of the patients who come to the diabetes&#xD;
        polyclinic is taken by the diabetes nurse and their physical examination is performed. In the&#xD;
        diabetes polyclinic, all patients are taught by the diabetes education nurse, the ability to&#xD;
        administer insulin, the ability to monitor blood glucose levels, medical nutrition therapy,&#xD;
        exercise, etc. subjects are taught. After the training, the patients are called for control&#xD;
        seven days later. However, a nursing follow-up is not applied during this process until it&#xD;
        comes to control again. In our study, all patients were given training on insulin&#xD;
        administration and testing by subcutaneous route using the Insulin Injection Application&#xD;
        Patient Education Content, accompanied by a diabetes polyclinic nurse. In line with the&#xD;
        content of the training, it was applied in the form of explaining to all patients with the&#xD;
        subcutaneous injection application model, answering the questions of the patients or their&#xD;
        relatives with the question-answer method, monitoring the patient while practicing on the&#xD;
        model by the researcher, and repeating the training in line with the needs. After the&#xD;
        training, all patients who accepted to participate in the study were recorded with the&#xD;
        Patient Information Form, as well as their individual characteristics and information about&#xD;
        the disease and treatment characteristics. D-FISQ was applied by the face-to-face interview&#xD;
        method. The application of the study was continued according to the groups to which they were&#xD;
        assigned by randomization (Figure 3.1).&#xD;
  &#xD;
        Experimental group intervention Patients who were randomly assigned to the intervention group&#xD;
        were informed about the method of the study. The patient was informed that participant would&#xD;
        be called before blood glucose measurement and insulin injection for three days to monitor&#xD;
        his fear of self-injection and testing. Insulin injection application training was repeated&#xD;
        on the first day. Telephone calls made within the scope of tele-health service were recorded&#xD;
        in the Telephone Interview Form. During the phone interviews, the questions that the patients&#xD;
        wanted to ask were answered. The topics that the patients most frequently asked for support&#xD;
        are listed in Table 1. The participant was asked to fill in the Insulin Injection Evaluation&#xD;
        Form according to his experience during the three-day home treatment process. At the end of&#xD;
        the three-day meeting, the tele-health service was terminated. D-FISQ was repeated to the&#xD;
        patients when they came to the hospital for control.&#xD;
  &#xD;
        Control group intervention Patients who were randomly assigned to the control group were&#xD;
        informed about the method of the study. Telehealth service in the control group was not&#xD;
        applied. The participant was asked to fill in the Insulin Injection Evaluation Form according&#xD;
        to his experience during the three-day home treatment process. D-FISQ was repeated to the&#xD;
        patients when they came to the hospital for control.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">February 17, 2022</start_date>
    <completion_date type="Actual">November 15, 2022</completion_date>
    <primary_completion_date type="Actual">June 15, 2022</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>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Injection Pain</measure>
      <time_frame>Through study completion, an average of 1 months</time_frame>
      <description>In order to identify the pain that occurs during insulin injection in patients, Insulin injection evaluation form was used. The form created by the researcher was used to determine the difficulties that patients face while administering insulin injections. The form consists of a total of 3 sections and 18 questions regarding the presence of pain, finger puncture pain intensity, drug administration pain intensity, injection administration difficulty, insulin dose skipping.&#xD;
  In order to evaluate the items in the form in terms of relevance and scope, it was submitted to the opinion of 4 experts working in the unit and working as educators in undergraduate and graduate programs. After the expert opinion, the items were reviewed and the form was finalized in line with the suggestions.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Fear</measure>
      <time_frame>Through study completion, an average of 1 months</time_frame>
      <description>The Diabetes Fear of Self Injecting and Self-testing Questionnaire-D-FISQ was used to define the fear of self-injection and testing in diabetics. The validity and reliability of the D-FISQ developed by Snoek et al. (1997) for the Turkish population was performed by Çelik and Pınar (2016). D-FISQ, which includes 15 statements, consists of two sub-dimensions: fear of self-injecting (fear of self-injecting-FSI, 6 statements) and fear of self-testing (fear of self-testing-FST, 9 statements).</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">70</enrollment>
    <condition>Nurse's Role</condition>
    <arm_group>
      <arm_group_label>Experimental</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients who were randomly assigned to the intervention group were informed about the method of the study. The patient was informed that he would be called before blood glucose measurement and insulin injection for three days to monitor his fear of self-injection and testing. Insulin injection application training was repeated on the first day. Telephone calls made within the scope of tele-health service were recorded in the Telephone Interview Form. During the phone interviews, the questions that the patients wanted to ask were answered. He was asked to fill in the Insulin Injection Evaluation Form according to his experience during the three-day home treatment process. At the end of the three-day meeting, the tele-health service was terminated. D-FISQ was repeated to the patients when they came to the hospital for control.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Patients who were randomly assigned to the control group were informed about the method of the study. Telehealth service in the control group was not applied. He was asked to fill in the Insulin Injection Evaluation Form according to his experience during the three-day home treatment process. D-FISQ was repeated to the patients when they came to the hospital for control.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Telenursing</intervention_name>
      <description>Patients who were randomly assigned to the intervention group were informed about the method of the study. The patient was informed that he would be called before blood glucose measurement and insulin injection for three days to monitor his fear of self-injection and testing. Insulin injection application training was repeated on the first day. Telephone calls made within the scope of tele-health service were recorded in the Telephone Interview Form. During the phone interviews, the questions that the patients wanted to ask were answered. He was asked to fill in the Insulin Injection Evaluation Form according to his experience during the three-day home treatment process. At the end of the three-day meeting, the tele-health service was terminated.</description>
      <arm_group_label>Experimental</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Being 18 years or older,&#xD;
  &#xD;
            -  Absence of physical, mental inadequacy and communication difficulties,&#xD;
  &#xD;
            -  Having a diagnosis of type II diabetes,&#xD;
  &#xD;
            -  Initiation of insulin therapy for the first time,&#xD;
  &#xD;
            -  Measuring blood sugar at least once a day,&#xD;
  &#xD;
            -  Self-administration of insulin injection,&#xD;
  &#xD;
            -  Ability to communicate by phone,&#xD;
  &#xD;
            -  Not having administered a self-injection of insulin before.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Having physical, mental inadequacy and communication difficulties,&#xD;
  &#xD;
            -  Having a history of allergy,&#xD;
  &#xD;
            -  Being pregnant,&#xD;
  &#xD;
            -  Not starting insulin therapy for the first time,&#xD;
  &#xD;
            -  Not measuring blood sugar at least once a day,&#xD;
  &#xD;
            -  Not self-administering insulin injection.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Demet İnangil</last_name>
      <role>Study Chair</role>
      <affiliation>Saglik Bilimleri Universitesi</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Demet İnangil</name>
        <address>
          <city>Istanbul</city>
          <zip>34668</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Saglik Bilimleri University</name>
        <address>
          <city>Istanbul</city>
          <zip>34668</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <citation>Souza-Junior VD, Mendes IA, Mazzo A, Godoy S. Application of telenursing in nursing practice: an integrative literature review. Appl Nurs Res. 2016 Feb;29:254-60. doi: 10.1016/j.apnr.2015.05.005. Epub 2015 May 20.</citation>
      <PMID>26856523</PMID>
    </reference>
    <reference>
      <citation>Peng X, Su Y, Hu Z, Sun X, Li X, Dolansky MA, Qu M, Hu X. Home-based telehealth exercise training program in Chinese patients with heart failure: A randomized controlled trial. Medicine (Baltimore). 2018 Aug;97(35):e12069. doi: 10.1097/MD.0000000000012069.</citation>
      <PMID>30170422</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Istanbul Saglik Bilimleri University</investigator_affiliation>
      <investigator_full_name>Demet İnangil, PhD</investigator_full_name>
      <investigator_title>Associate Proffessor</investigator_title>
    </responsible_party>
    <keyword>telenursing, diabetes, pain, fear</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/NCT06013826
  org study id: 2021/0650
  nct id: NCT06013826
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Aim: The aim of the study is to examine the effects of nursing follow-up with telenursing on
        the pain and fear factors related to self-injection testing in diabetic individuals who are
        started on insulin therapy for the first time.
  
        Materials and Methods: The research was implemented in a randomized controlled experimental
        design. The sample consisted of 70 individuals with diabetes who started insulin therapy for
        the first time in the diabetes polyclinic of a state university hospital in Istanbul between
        17 February and 15 November 2022. Individuals who will start insulin therapy for the first
        time are directed to the diabetes polyclinic. Insulin Injection Application to all patients
        in the diabetes polyclinic. In line with the Patient Education Content, the ability to
        administer insulin, the ability to monitor blood glucose levels, medical nutrition therapy,
        exercise, etc. applied after the training given on the subjects. Data were collected with the
        Patient Information Form, Diabetic Self-Injection and Fear of Testing Questionnaire Form
        (D-SFIQ), Insulin Injection Evaluation Form. Patients assigned to the intervention group were
        given telehealth service for three days for fear of self-injection and testing.
  The sample of the study consisted of 70 patients who met the inclusion criteria and agreed to
        participate. Insulin therapy was evaluated according to the inclusion criteria and those who
        agreed to participate in the study. 19 doctors and 2 nurses work in the diabetes polyclinic.
        Individuals who will start insulin therapy for the first time after a doctor's examination
        are referred to the diabetes polyclinic. The history of the patients who come to the diabetes
        polyclinic is taken by the diabetes nurse and their physical examination is performed. In the
        diabetes polyclinic, all patients are taught by the diabetes education nurse, the ability to
        administer insulin, the ability to monitor blood glucose levels, medical nutrition therapy,
        exercise, etc. subjects are taught. After the training, the patients are called for control
        seven days later. However, a nursing follow-up is not applied during this process until it
        comes to control again. In our study, all patients were given training on insulin
        administration and testing by subcutaneous route using the Insulin Injection Application
        Patient Education Content, accompanied by a diabetes polyclinic nurse. In line with the
        content of the training, it was applied in the form of explaining to all patients with the
        subcutaneous injection application model, answering the questions of the patients or their
        relatives with the question-answer method, monitoring the patient while practicing on the
        model by the researcher, and repeating the training in line with the needs. After the
        training, all patients who accepted to participate in the study were recorded with the
        Patient Information Form, as well as their individual characteristics and information about
        the disease and treatment characteristics. D-FISQ was applied by the face-to-face interview
        method. The application of the study was continued according to the groups to which they were
        assigned by randomization (Figure 3.1).
  
        Experimental group intervention Patients who were randomly assigned to the intervention group
        were informed about the method of the study. The patient was informed that participant would
        be called before blood glucose measurement and insulin injection for three days to monitor
        his fear of self-injection and testing. Insulin injection application training was repeated
        on the first day. Telephone calls made within the scope of tele-health service were recorded
        in the Telephone Interview Form. During the phone interviews, the questions that the patients
        wanted to ask were answered. The topics that the patients most frequently asked for support
        are listed in Table 1. The participant was asked to fill in the Insulin Injection Evaluation
        Form according to his experience during the three-day home treatment process. At the end of
        the three-day meeting, the tele-health service was terminated. D-FISQ was repeated to the
        patients when they came to the hospital for control.
  
        Control group intervention Patients who were randomly assigned to the control group were
        informed about the method of the study. Telehealth service in the control group was not
        applied. The participant was asked to fill in the Insulin Injection Evaluation Form according
        to his experience during the three-day home treatment process. D-FISQ was repeated to the
        patients when they came to the hospital for control.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Injection Pain
  time frame: Through study completion, an average of 1 months
  description: In order to identify the pain that occurs during insulin injection in patients, Insulin injection evaluation form was used. The form created by the researcher was used to determine the difficulties that patients face while administering insulin injections. The form consists of a total of 3 sections and 18 questions regarding the presence of pain, finger puncture pain intensity, drug administration pain intensity, injection administration difficulty, insulin dose skipping.
  In order to evaluate the items in the form in terms of relevance and scope, it was submitted to the opinion of 4 experts working in the unit and working as educators in undergraduate and graduate programs. After the expert opinion, the items were reviewed and the form was finalized in line with the suggestions.
  measure: Fear
  time frame: Through study completion, an average of 1 months
  description: The Diabetes Fear of Self Injecting and Self-testing Questionnaire-D-FISQ was used to define the fear of self-injection and testing in diabetics. The validity and reliability of the D-FISQ developed by Snoek et al. (1997) for the Turkish population was performed by Çelik and Pınar (2016). D-FISQ, which includes 15 statements, consists of two sub-dimensions: fear of self-injecting (fear of self-injecting-FSI, 6 statements) and fear of self-testing (fear of self-testing-FST, 9 statements).
  arm group label: Experimental
  arm group type: Experimental
  description: Patients who were randomly assigned to the intervention group were informed about the method of the study. The patient was informed that he would be called before blood glucose measurement and insulin injection for three days to monitor his fear of self-injection and testing. Insulin injection application training was repeated on the first day. Telephone calls made within the scope of tele-health service were recorded in the Telephone Interview Form. During the phone interviews, the questions that the patients wanted to ask were answered. He was asked to fill in the Insulin Injection Evaluation Form according to his experience during the three-day home treatment process. At the end of the three-day meeting, the tele-health service was terminated. D-FISQ was repeated to the patients when they came to the hospital for control.
  arm group label: Control
  arm group type: No Intervention
  description: Patients who were randomly assigned to the control group were informed about the method of the study. Telehealth service in the control group was not applied. He was asked to fill in the Insulin Injection Evaluation Form according to his experience during the three-day home treatment process. D-FISQ was repeated to the patients when they came to the hospital for control.
  intervention type: Other
  intervention name: Telenursing
  description: Patients who were randomly assigned to the intervention group were informed about the method of the study. The patient was informed that he would be called before blood glucose measurement and insulin injection for three days to monitor his fear of self-injection and testing. Insulin injection application training was repeated on the first day. Telephone calls made within the scope of tele-health service were recorded in the Telephone Interview Form. During the phone interviews, the questions that the patients wanted to ask were answered. He was asked to fill in the Insulin Injection Evaluation Form according to his experience during the three-day home treatment process. At the end of the three-day meeting, the tele-health service was terminated.
  arm group label: Experimental
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Demet İnangil
  role: Study Chair
  affiliation: Saglik Bilimleri Universitesi
  facility: 
  facility: 
  country: Turkey
  citation: Souza-Junior VD, Mendes IA, Mazzo A, Godoy S. Application of telenursing in nursing practice: an integrative literature review. Appl Nurs Res. 2016 Feb;29:254-60. doi: 10.1016/j.apnr.2015.05.005. Epub 2015 May 20.
  PMID: 26856523
  citation: Peng X, Su Y, Hu Z, Sun X, Li X, Dolansky MA, Qu M, Hu X. Home-based telehealth exercise training program in Chinese patients with heart failure: A randomized controlled trial. Medicine (Baltimore). 2018 Aug;97(35):e12069. doi: 10.1097/MD.0000000000012069.
  PMID: 30170422
  responsible party type: Principal Investigator
  investigator affiliation: Istanbul Saglik Bilimleri University
  investigator full name: Demet İnangil, PhD
  investigator title: Associate Proffessor
  sharing ipd: No