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/NCT05973266</url>
    </required_header>
    <id_info>
      <org_study_id>IstanbulUC-FNHF-KS-01</org_study_id>
      <nct_id>NCT05973266</nct_id>
    </id_info>
    <brief_title>The Effect of Mobile Application-Based Bowel Preparation Training on the Patient's Education Whom Colonoscopy is Planned</brief_title>
    <official_title>The Effect of Mobile Application-Based Bowel Preparation Training on the Patient's Bowel Preparation Compliance, Quality and Anxiety Level in Patients for Whom Colonoscopy is Planned</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Kubra Sengor</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>The Scientific and Technological Research Council of Turkey</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Istanbul University - Cerrahpasa (IUC)</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>
        Colonoscopy is the examination of the large intestine with an instrument called a&#xD;
        colonoscope. To make an accurate evaluation during a colonoscopy performed for diagnosis and&#xD;
        treatment, adequate preparation of the large intestine must be made. Information given to&#xD;
        patients is very important for adequate bowel preparation and adherence to treatment.&#xD;
  &#xD;
        Therefore, this study was planned as a prospective, single-blind randomized controlled study&#xD;
        to determine the effect of mobile application-based bowel preparation training on patients'&#xD;
        bowel preparation compliance, quality and anxiety level in patients scheduled for&#xD;
        colonoscopy.&#xD;
  &#xD;
        The study will be carried out with 160 patients (experimental: 80, control: 80) who will&#xD;
        apply to the Istanbul University Istanbul Medical Faculty Hospital General Surgery Department&#xD;
        Endoscopy Unit, who will undergo colonoscopy as an outpatient.&#xD;
  &#xD;
        Both groups will receive oral and written instructions for bowel preparation. In addition,&#xD;
        the smart phone app group will received instructions through a medical smart phone app. The&#xD;
        primary outcome was the rate of adequate bowel preparation according to the Boston bowel&#xD;
        preparation scale score. The secondary outcomes included patient compliance.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Colorectal cancers (CRC) are the third most common cancers worldwide, regardless of age and&#xD;
        gender, and the second among cancer deaths. In terms of the incidence of colorectal cancers&#xD;
        in Turkey, regardless of gender, it ranks third in all age groups (9.8% in men, 8.1% in&#xD;
        women) (Turkey Unified Database, 2017). According to the Global Cancer 2020 data published by&#xD;
        the International Agency for Research on Cancer (IARC), it is predicted that approximately&#xD;
        21,000 individuals will be diagnosed with colorectal cancer in 2020 and the estimated&#xD;
        age-standardized death rate will be 10.1 per 100,000 individuals. Colonoscopy, which is the&#xD;
        gold standard for early diagnosis of colorectal cancers, reduces cancer-related morbidity and&#xD;
        mortality rates (World Health Organization, 2022).&#xD;
  &#xD;
        Colonoscopy is a lower gastrointestinal system endoscopy method that enables imaging of the&#xD;
        large intestine (colon) for the purposes of screening, diagnosis, treatment and monitoring of&#xD;
        colorectal and anal canal pathologies. In the colonoscopy procedure, adequate intestinal&#xD;
        preparation is necessary for a good visualization of the entire mucosa and for an accurate&#xD;
        evaluation. American Society for Gastrointestinal Endoscopy (ASGE), ideal bowel preparation&#xD;
        (BH); defined as the rapid clearance of all macroscopic and microscopic fecal load in the&#xD;
        colon without disturbing the patient's comfort and fluid-electrolyte balance.&#xD;
  &#xD;
        Inadequate bowel cleansing rates ranging from 10% to 75% have been reported in studies. It is&#xD;
        stated that when the bowel preparation of the patients is insufficient, 45% less polyps are&#xD;
        detected, and the rate of incomplete and canceled procedures is 5%. In addition, gas&#xD;
        compression and explosion, which can be seen rarely as a result of gas insufflation during&#xD;
        colonoscopy due to insufficient bowel preparation, can cause perforation of the intestines&#xD;
        and undesirable events such as bleeding. As a result, inadequate bowel cleansing can cause&#xD;
        repetition or prolongation of the procedure, loss of labor, time and cost for patients and&#xD;
        healthcare personnel.&#xD;
  &#xD;
        Before colonoscopy, nurses provide patients with written and oral bowel preparation standard&#xD;
        training set by the institution. However, many studies suggest that this training should be&#xD;
        supported by visual and auditory tools to increase its effectiveness. In interventional&#xD;
        studies aimed at increasing the effectiveness of colonoscopy bowel preparation, the use of&#xD;
        educational booklets, patient education with poster images, patient education with both&#xD;
        visual use and educational videos, telephone/short message, interactive social media and&#xD;
        patient education with the use of telephone applications methods were used.&#xD;
  &#xD;
        As a result of the literature review, Mobile Application Based Bowel Preparation Training,&#xD;
        which is an innovative method, was planned in order to improve the quality of colonoscopy&#xD;
        bowel preparation. In this study, it was determined that the quality of bowel preparation and&#xD;
        compliance with the procedure will increase by applying Mobile Application-Based Bowel&#xD;
        Preparation Training together with the standard education method in patient education before&#xD;
        colonoscopy; anxiety is predicted to decrease.&#xD;
  &#xD;
        Aim This study was planned as a prospective, single-blind randomized controlled study to&#xD;
        determine the effect of mobile application-based bowel preparation training on patients'&#xD;
        bowel preparation compliance, quality and anxiety level in patients scheduled for&#xD;
        colonoscopy. With the increase in the quality of bowel preparation, effective and accurate&#xD;
        evaluation of colon pathologies during colonoscopy and, as a result, early diagnosis of colon&#xD;
        cancer will be provided. With adequate bowel preparation, the risk of complications&#xD;
        (perforation, hemorrhage, etc.) that may occur during colonoscopy will be reduced, and labor,&#xD;
        time and cost loss due to repeated or prolonged colonoscopy will be prevented.&#xD;
  &#xD;
        Material Method In this study, in order to determine the effect of mobile application-based&#xD;
        bowel preparation training on the quality of bowel preparation, compliance and anxiety level&#xD;
        of patients who are planned for colonoscopy; The calculation (d-value) method developed by&#xD;
        Cohen was used to calculate the effect size. To determine the effect size index d. The&#xD;
        findings of the study, which investigated the effect of mobile application on patient bowel&#xD;
        cleansing before colonoscopy, were used. In the calculation made using the findings of this&#xD;
        study, the effect size of the bowel cleansing efficiency between the two groups&#xD;
        (Experiment=7.70±1.1; Control=7.70±0.8; p=0.007) was determined to be d=0.48. In this&#xD;
        context, a sample group of 140 people, 70 people in each group, was determined with the help&#xD;
        of the G-power (version 3.1) package program, accompanied by the specified criteria, with&#xD;
        d=0.48, α=0.05 (error margin), 1-β=0.80 (power). Due to the loss of patients who left the&#xD;
        study during data collection, 10 individuals will be added to the experimental and control&#xD;
        groups, and the data collection process will be completed. The sample will consist of&#xD;
        patients who meet the inclusion criteria and agree to participate in the study, whose&#xD;
        colonoscopy procedure is planned.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 3, 2021</start_date>
    <completion_date type="Anticipated">December 29, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 27, 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>Crossover Assignment</intervention_model>
      <intervention_model_description>Randomized controlled experimental design</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>endoscopist blinded</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>quality of bowel preparation</measure>
      <time_frame>filled in by the endoscopist during the colonoscopy procedure after training</time_frame>
      <description>The Boston bowel preparation scale is a four-point (0-3) assessment tool for bowel cleansing administered separately for each of the three sections of the colon during colonoscopy.Each region of the colon receives a &quot;segment score&quot; from 0 to 3 and these segment scores are summed for a total Boston bowel preparation scale score ranging from 0 to 9. Therefore, the maximum Boston bowel preparation scale score for a perfectly clean colon without any residual liquid is 9 and the minimum Boston bowel preparation scale score for an unprepared colon is 0.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Anxiety</measure>
      <time_frame>will be administered to patients before colonoscopy</time_frame>
      <description>State-Trait Anxiety Inventory (STAI); STAI-I was developed by Spielberger in 1970. The scale consists of 20 items. The answers range from 1-4. The total point value obtained from the scale is between 20-80. A high score indicates a high level of anxiety. STAI 2 Trait Anxiety Scale; It aims to measure how the individual feels, that is, his trait anxiety, regardless of the situation and conditions he is in. These individuals also experience state anxiety more frequently and intensely than others. In answering the state anxiety scale; choosing one of the options &quot;Not at all&quot;, &quot;A little&quot;, &quot;A lot&quot;, &quot;Totally&quot; according to the level of severity of the feelings, behaviors or thoughts expressed by the items; In answering the trait anxiety scale, it is required to select and mark one of the options &quot;Almost Never&quot;, &quot;Sometimes&quot;, &quot;Very Often&quot; and &quot;Almost Always&quot; according to the frequency level of the feelings, behaviors or thoughts expressed by the items.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">160</enrollment>
    <condition>Colon Disease</condition>
    <condition>Colon Cancer</condition>
    <arm_group>
      <arm_group_label>Experimental Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients using mobile application as well as verbal and written information in bowel preparation training in patients who will undergo colonoscopy will constitute the experimental group.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Patients who will be given oral and written information in bowel preparation training in patients who will undergo colonoscopy will form the control group.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Mobile Application-Based Bowel Preparation Training</intervention_name>
      <description>The contents of the training in the mobile application where the patients receive bowel preparation training before the procedure are; short videos, images and slides about colonoscopy, bowel preparation drugs, liquid-clear diet and foods recommendations.A mobile application-based training will be provided to guide patients, where user (patient) usage activities are monitored by the researcher, sending notifications or reminders to the patient in accordance with the colonoscopy procedure date.</description>
      <arm_group_label>Experimental Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  18 Years to 65 Years, Internet-enabled smart phone Outpatient admission to endoscopy&#xD;
               Patient undergoing colonoscopy for the first time Patients who agreed to participate&#xD;
               in the study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Have undergone colon and abdominal surgery Active lower gastrointestinal bleeding&#xD;
               Known dementia etc. patients with cognitive disorders&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Kübra Şengör, Msc</last_name>
      <role>Principal Investigator</role>
      <affiliation>Istanbul University - Cerrahpasa (IUC)</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Kübra Şengör, Msc</last_name>
      <phone>05422713460</phone>
      <email>kubra.sengor@iuc.edu.tr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Istanbul University - Cerrahpasa (IUC)</name>
        <address>
          <city>Istanbul</city>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>kubra sengor</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Istanbul University - Cerrahpasa (IUC)</investigator_affiliation>
      <investigator_full_name>Kubra Sengor</investigator_full_name>
      <investigator_title>Research Assistant</investigator_title>
    </responsible_party>
    <keyword>colonoscopy</keyword>
    <keyword>bowel preparation</keyword>
    <keyword>mobile application</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Colonic Diseases</mesh_term>
    </condition_browse>
    <!-- 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/NCT05973266
  org study id: IstanbulUC-FNHF-KS-01
  nct id: NCT05973266
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Colonoscopy is the examination of the large intestine with an instrument called a
        colonoscope. To make an accurate evaluation during a colonoscopy performed for diagnosis and
        treatment, adequate preparation of the large intestine must be made. Information given to
        patients is very important for adequate bowel preparation and adherence to treatment.
  
        Therefore, this study was planned as a prospective, single-blind randomized controlled study
        to determine the effect of mobile application-based bowel preparation training on patients'
        bowel preparation compliance, quality and anxiety level in patients scheduled for
        colonoscopy.
  
        The study will be carried out with 160 patients (experimental: 80, control: 80) who will
        apply to the Istanbul University Istanbul Medical Faculty Hospital General Surgery Department
        Endoscopy Unit, who will undergo colonoscopy as an outpatient.
  
        Both groups will receive oral and written instructions for bowel preparation. In addition,
        the smart phone app group will received instructions through a medical smart phone app. The
        primary outcome was the rate of adequate bowel preparation according to the Boston bowel
        preparation scale score. The secondary outcomes included patient compliance.
  Colorectal cancers (CRC) are the third most common cancers worldwide, regardless of age and
        gender, and the second among cancer deaths. In terms of the incidence of colorectal cancers
        in Turkey, regardless of gender, it ranks third in all age groups (9.8% in men, 8.1% in
        women) (Turkey Unified Database, 2017). According to the Global Cancer 2020 data published by
        the International Agency for Research on Cancer (IARC), it is predicted that approximately
        21,000 individuals will be diagnosed with colorectal cancer in 2020 and the estimated
        age-standardized death rate will be 10.1 per 100,000 individuals. Colonoscopy, which is the
        gold standard for early diagnosis of colorectal cancers, reduces cancer-related morbidity and
        mortality rates (World Health Organization, 2022).
  
        Colonoscopy is a lower gastrointestinal system endoscopy method that enables imaging of the
        large intestine (colon) for the purposes of screening, diagnosis, treatment and monitoring of
        colorectal and anal canal pathologies. In the colonoscopy procedure, adequate intestinal
        preparation is necessary for a good visualization of the entire mucosa and for an accurate
        evaluation. American Society for Gastrointestinal Endoscopy (ASGE), ideal bowel preparation
        (BH); defined as the rapid clearance of all macroscopic and microscopic fecal load in the
        colon without disturbing the patient's comfort and fluid-electrolyte balance.
  
        Inadequate bowel cleansing rates ranging from 10% to 75% have been reported in studies. It is
        stated that when the bowel preparation of the patients is insufficient, 45% less polyps are
        detected, and the rate of incomplete and canceled procedures is 5%. In addition, gas
        compression and explosion, which can be seen rarely as a result of gas insufflation during
        colonoscopy due to insufficient bowel preparation, can cause perforation of the intestines
        and undesirable events such as bleeding. As a result, inadequate bowel cleansing can cause
        repetition or prolongation of the procedure, loss of labor, time and cost for patients and
        healthcare personnel.
  
        Before colonoscopy, nurses provide patients with written and oral bowel preparation standard
        training set by the institution. However, many studies suggest that this training should be
        supported by visual and auditory tools to increase its effectiveness. In interventional
        studies aimed at increasing the effectiveness of colonoscopy bowel preparation, the use of
        educational booklets, patient education with poster images, patient education with both
        visual use and educational videos, telephone/short message, interactive social media and
        patient education with the use of telephone applications methods were used.
  
        As a result of the literature review, Mobile Application Based Bowel Preparation Training,
        which is an innovative method, was planned in order to improve the quality of colonoscopy
        bowel preparation. In this study, it was determined that the quality of bowel preparation and
        compliance with the procedure will increase by applying Mobile Application-Based Bowel
        Preparation Training together with the standard education method in patient education before
        colonoscopy; anxiety is predicted to decrease.
  
        Aim This study was planned as a prospective, single-blind randomized controlled study to
        determine the effect of mobile application-based bowel preparation training on patients'
        bowel preparation compliance, quality and anxiety level in patients scheduled for
        colonoscopy. With the increase in the quality of bowel preparation, effective and accurate
        evaluation of colon pathologies during colonoscopy and, as a result, early diagnosis of colon
        cancer will be provided. With adequate bowel preparation, the risk of complications
        (perforation, hemorrhage, etc.) that may occur during colonoscopy will be reduced, and labor,
        time and cost loss due to repeated or prolonged colonoscopy will be prevented.
  
        Material Method In this study, in order to determine the effect of mobile application-based
        bowel preparation training on the quality of bowel preparation, compliance and anxiety level
        of patients who are planned for colonoscopy; The calculation (d-value) method developed by
        Cohen was used to calculate the effect size. To determine the effect size index d. The
        findings of the study, which investigated the effect of mobile application on patient bowel
        cleansing before colonoscopy, were used. In the calculation made using the findings of this
        study, the effect size of the bowel cleansing efficiency between the two groups
        (Experiment=7.70±1.1; Control=7.70±0.8; p=0.007) was determined to be d=0.48. In this
        context, a sample group of 140 people, 70 people in each group, was determined with the help
        of the G-power (version 3.1) package program, accompanied by the specified criteria, with
        d=0.48, α=0.05 (error margin), 1-β=0.80 (power). Due to the loss of patients who left the
        study during data collection, 10 individuals will be added to the experimental and control
        groups, and the data collection process will be completed. The sample will consist of
        patients who meet the inclusion criteria and agree to participate in the study, whose
        colonoscopy procedure is planned.
  allocation: Randomized
  intervention model: Crossover Assignment
  intervention model description: Randomized controlled experimental design
  primary purpose: Other
  masking: Single (Outcomes Assessor)
  masking description: endoscopist blinded
  measure: quality of bowel preparation
  time frame: filled in by the endoscopist during the colonoscopy procedure after training
  description: The Boston bowel preparation scale is a four-point (0-3) assessment tool for bowel cleansing administered separately for each of the three sections of the colon during colonoscopy.Each region of the colon receives a "segment score" from 0 to 3 and these segment scores are summed for a total Boston bowel preparation scale score ranging from 0 to 9. Therefore, the maximum Boston bowel preparation scale score for a perfectly clean colon without any residual liquid is 9 and the minimum Boston bowel preparation scale score for an unprepared colon is 0.
  measure: Anxiety
  time frame: will be administered to patients before colonoscopy
  description: State-Trait Anxiety Inventory (STAI); STAI-I was developed by Spielberger in 1970. The scale consists of 20 items. The answers range from 1-4. The total point value obtained from the scale is between 20-80. A high score indicates a high level of anxiety. STAI 2 Trait Anxiety Scale; It aims to measure how the individual feels, that is, his trait anxiety, regardless of the situation and conditions he is in. These individuals also experience state anxiety more frequently and intensely than others. In answering the state anxiety scale; choosing one of the options "Not at all", "A little", "A lot", "Totally" according to the level of severity of the feelings, behaviors or thoughts expressed by the items; In answering the trait anxiety scale, it is required to select and mark one of the options "Almost Never", "Sometimes", "Very Often" and "Almost Always" according to the frequency level of the feelings, behaviors or thoughts expressed by the items.
  arm group label: Experimental Group
  arm group type: Experimental
  description: Patients using mobile application as well as verbal and written information in bowel preparation training in patients who will undergo colonoscopy will constitute the experimental group.
  arm group label: Control Group
  arm group type: No Intervention
  description: Patients who will be given oral and written information in bowel preparation training in patients who will undergo colonoscopy will form the control group.
  intervention type: Behavioral
  intervention name: Mobile Application-Based Bowel Preparation Training
  description: The contents of the training in the mobile application where the patients receive bowel preparation training before the procedure are; short videos, images and slides about colonoscopy, bowel preparation drugs, liquid-clear diet and foods recommendations.A mobile application-based training will be provided to guide patients, where user (patient) usage activities are monitored by the researcher, sending notifications or reminders to the patient in accordance with the colonoscopy procedure date.
  arm group label: Experimental Group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Kübra Şengör, Msc
  role: Principal Investigator
  affiliation: Istanbul University - Cerrahpasa (IUC)
  last name: Kübra Şengör, Msc
  phone: 05422713460
  email: kubra.sengor@iuc.edu.tr
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  responsible party type: Sponsor-Investigator
  investigator affiliation: Istanbul University - Cerrahpasa (IUC)
  investigator full name: Kubra Sengor
  investigator title: Research Assistant
  mesh term: Colonic Diseases