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/NCT06003543</url>
    </required_header>
    <id_info>
      <org_study_id>E-19003918-730.08.03-347141</org_study_id>
      <nct_id>NCT06003543</nct_id>
    </id_info>
    <brief_title>The Effect of Virtual Reality Application on Pain, Fear and Anxiety in Patients Undergoing Colonoscopy</brief_title>
    <official_title>The Effect of Virtual Reality Application on Pain, Fear and Anxiety in Patients Undergoing Colonoscopy:</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ataturk University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ataturk 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>
        Colonoscopy; It is a method that allows viewing the large intestines and diagnosing or&#xD;
        treating gastrointestinal system diseases by entering through the anus with a flexible, thin&#xD;
        tube with a camera at the end, called a colonoscope. All parts of the large intestine with&#xD;
        colonoscopy; ascending colon, hepatic flexure, transverse colon, splenic flexure, descending&#xD;
        colon, sigmoid colon, rectum and anal canal by retroflexion can be evaluated. Colonoscopic&#xD;
        interventions applied in gastroenterology cause pain, fear and anxiety in patients.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        High anxiety levels before the procedure can negatively affect the procedure by reducing&#xD;
        patient compliance and may lead to the incompleteness of the procedure. Anxiety and fear&#xD;
        experienced during colonoscopy cause more pain during the procedure.&#xD;
  &#xD;
        In addition to pharmacological methods, there are non-pharmacological methods to provide&#xD;
        patient comfort and manage the level of pain, fear and anxiety in interventional procedures&#xD;
        such as colonoscopy. The methods used can be grouped under three main headings: physical,&#xD;
        supportive and cognitive-behavioral. Cognitive-behavioral methods, which can be performed&#xD;
        with practices such as relaxation and distraction, help control pain, fear and anxiety level.&#xD;
  &#xD;
        The virtual reality application, developed thanks to the advancement of computer technology,&#xD;
        is used as a cognitive-behavioral method to alleviate pain, fear and anxiety. With this&#xD;
        method, the process of processing incoming pain signals slows down in patients who focus&#xD;
        their attention on the environment they see, and fear, anxiety and pain are perceived less.&#xD;
        It is important to relieve the patient's pain, fear and anxiety before colonoscopic&#xD;
        interventions, to diagnose the patient correctly, to facilitate the health personnel who will&#xD;
        perform the procedure, to facilitate the patient's compliance with the procedure, to prevent&#xD;
        possible complications and to increase patient satisfaction. This study was planned to&#xD;
        examine the effect of relaxation exercise, which will be performed with virtual reality&#xD;
        application, which will distract their attention before and during the colonoscopy, on the&#xD;
        experienced pain, fear and anxiety levels.&#xD;
  &#xD;
        The research will be conducted as a randomized, experimental study with a pretest-posttest&#xD;
        control group. The sample of the study will be composed of a total of 46 patients, 23&#xD;
        experimental and 23 control groups, who will be subjected to colonoscopy between August 2023-&#xD;
        August 2024 in the Colonoscopy Unit of the Gastroenterology Polyclinic of Fırat University&#xD;
        Hospital. Virtual reality application will be applied to the patient in the experimental&#xD;
        group by the researcher 10 minutes before the procedure and 10-15 minutes during the&#xD;
        procedure. The first measurement will be obtained by applying the Visual Analog Scale-Pain,&#xD;
        Visual Analog Scale-Fear, Visual Analog Scale-Anxiety, State-Trait Anxiety Inventory (DSQ)&#xD;
        and Patient Information Form to the patient in the experimental group before the procedure.&#xD;
        The second measurement will be obtained by applying the Visual Analog Scale-Pain, Visual&#xD;
        Analog Scale-Fear, Visual Analog Scale-Anxiety and State-Trait Anxiety Scale (DSQ) to the&#xD;
        patient 10-15 minutes after the procedure. No intervention will be performed on the patients&#xD;
        in the control group. 1 measurement will be obtained by applying the Patient Information&#xD;
        Form, Visual Analog Scale-Pain, Visual Analog Scale-Fear, Visual Analog Scale-Anxiety and&#xD;
        State-Trait Anxiety Scale before the procedure only. After the procedure, the second&#xD;
        measurement will be obtained by re-applying the other forms except the Patient Information&#xD;
        Form. The data will be analyzed using the SPSS 23 program. Shapiro Wilk test, t test,&#xD;
        Mann-Whitney U test, Wilcoxon test and Chi-square analysis will be used in the analysis of&#xD;
        the data.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">March 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 1, 2024</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>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Visual Analog Scale -Pain</measure>
      <time_frame>1 hours later</time_frame>
      <description>Patients are asked to show the intensity of pain on a 10 cm long vertical or horizontal line during activity or rest. It has numbered shapes ranging from 1-10. The line has 0 at the beginning and 10 at the end. 10 means unbearable pain, 0 means no pain. The VAS scale is frequently used in the evaluation of pain severity. While the patient marks the pain he/she has felt on this line, each point marked is measured in cm</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Visual Analog Scale - Fear</measure>
      <time_frame>1 hours later</time_frame>
      <description>Patients are asked to show the intensity of fear on a 10 cm long vertical or horizontal line during activity or rest. It has numbered shapes ranging from 1-10. The line has 0 at the beginning and 10 at the end. 10 means unbearable fear, 0 means no fear. The VAS scale is frequently used in the evaluation of fear severity. While the patient marks the fear he/she has felt on this line, each marked point is measured in cm</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Visual Analog Scale -Anxiety</measure>
      <time_frame>1 hours later</time_frame>
      <description>Patients are asked to show the intensity of anxiety on a 10 cm long horizontal line during activity or rest. The line has 0 at the beginning and 10 at the end. 10 means unbearable pain, 0 means no pain. VAS is frequently used in the evaluation of pain intensity. While the patient marks the anxiety he/she has felt on this line, each marked point is measured in cm</description>
    </primary_outcome>
    <primary_outcome>
      <measure>State-Trait Anxiety Inventory</measure>
      <time_frame>1 hours later</time_frame>
      <description>Developed by Spielberg et al. (1970) to measure the state and trait anxiety levels of individuals, the scale, which consists of two parts and the English name is Speilberg's State-Trait Anxiety Inventory (STAI), is a self-tested reliability and validity study in Turkish by Öner and Le Compte (1977). assessment scale (37-38) In this study, the part of the scale measuring trait anxiety was used to determine the trait anxiety levels of the patients. Trait Anxiety Inventory is a 4-point Likert-type with 20 items and is scored as &quot;never&quot;: 1, &quot;a little&quot;: 2, &quot;a lot&quot;: 3, &quot;completely&quot;: 4, according to the severity of the feelings, thoughts or behaviors expressed by the items. . There are direct or reverse scored statements in the scale.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Virtual Reality</condition>
    <arm_group>
      <arm_group_label>Virtual Reality</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>virtual glasses will be applied</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>no application will be made</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Virtual Reality</intervention_name>
      <description>Virtual Reality</description>
      <arm_group_label>Virtual Reality</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Able to speak and understand Turkish&#xD;
  &#xD;
            -  Having cognitive competence to answer data collection tools&#xD;
  &#xD;
            -  Absence of communication problems (hearing, language, understanding, etc.)&#xD;
  &#xD;
            -  Not having a psychiatric diagnosis&#xD;
  &#xD;
            -  Absence of a history of convulsions&#xD;
  &#xD;
            -  Patients who underwent local application in colonoscopy&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Those with communication problems&#xD;
  &#xD;
            -  Those with psychiatric problems&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Gülcan B.TURAN</last_name>
      <role>Principal Investigator</role>
      <affiliation>Firat University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Gülcan B.TURAN</last_name>
      <phone>05065576086</phone>
      <email>glcnbah@hotmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Mukadder Mollaoğlu</last_name>
      <phone>506 557 60 86</phone>
      <email>mollaoglumukadder@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Fırat university</name>
        <address>
          <city>Elazığ</city>
          <state>Center</state>
          <zip>25240</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Gülcan Bahçecioğlu Turan</last_name>
        <phone>506 557 60 86</phone>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Ataturk University</investigator_affiliation>
      <investigator_full_name>gülcan bahcecioğlu</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Fear</keyword>
    <keyword>Colonoscopy,</keyword>
    <keyword>Pain</keyword>
    <keyword>Anxiety</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/NCT06003543
  org study id: E-19003918-730.08.03-347141
  nct id: NCT06003543
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Colonoscopy; It is a method that allows viewing the large intestines and diagnosing or
        treating gastrointestinal system diseases by entering through the anus with a flexible, thin
        tube with a camera at the end, called a colonoscope. All parts of the large intestine with
        colonoscopy; ascending colon, hepatic flexure, transverse colon, splenic flexure, descending
        colon, sigmoid colon, rectum and anal canal by retroflexion can be evaluated. Colonoscopic
        interventions applied in gastroenterology cause pain, fear and anxiety in patients.
  High anxiety levels before the procedure can negatively affect the procedure by reducing
        patient compliance and may lead to the incompleteness of the procedure. Anxiety and fear
        experienced during colonoscopy cause more pain during the procedure.
  
        In addition to pharmacological methods, there are non-pharmacological methods to provide
        patient comfort and manage the level of pain, fear and anxiety in interventional procedures
        such as colonoscopy. The methods used can be grouped under three main headings: physical,
        supportive and cognitive-behavioral. Cognitive-behavioral methods, which can be performed
        with practices such as relaxation and distraction, help control pain, fear and anxiety level.
  
        The virtual reality application, developed thanks to the advancement of computer technology,
        is used as a cognitive-behavioral method to alleviate pain, fear and anxiety. With this
        method, the process of processing incoming pain signals slows down in patients who focus
        their attention on the environment they see, and fear, anxiety and pain are perceived less.
        It is important to relieve the patient's pain, fear and anxiety before colonoscopic
        interventions, to diagnose the patient correctly, to facilitate the health personnel who will
        perform the procedure, to facilitate the patient's compliance with the procedure, to prevent
        possible complications and to increase patient satisfaction. This study was planned to
        examine the effect of relaxation exercise, which will be performed with virtual reality
        application, which will distract their attention before and during the colonoscopy, on the
        experienced pain, fear and anxiety levels.
  
        The research will be conducted as a randomized, experimental study with a pretest-posttest
        control group. The sample of the study will be composed of a total of 46 patients, 23
        experimental and 23 control groups, who will be subjected to colonoscopy between August 2023-
        August 2024 in the Colonoscopy Unit of the Gastroenterology Polyclinic of Fırat University
        Hospital. Virtual reality application will be applied to the patient in the experimental
        group by the researcher 10 minutes before the procedure and 10-15 minutes during the
        procedure. The first measurement will be obtained by applying the Visual Analog Scale-Pain,
        Visual Analog Scale-Fear, Visual Analog Scale-Anxiety, State-Trait Anxiety Inventory (DSQ)
        and Patient Information Form to the patient in the experimental group before the procedure.
        The second measurement will be obtained by applying the Visual Analog Scale-Pain, Visual
        Analog Scale-Fear, Visual Analog Scale-Anxiety and State-Trait Anxiety Scale (DSQ) to the
        patient 10-15 minutes after the procedure. No intervention will be performed on the patients
        in the control group. 1 measurement will be obtained by applying the Patient Information
        Form, Visual Analog Scale-Pain, Visual Analog Scale-Fear, Visual Analog Scale-Anxiety and
        State-Trait Anxiety Scale before the procedure only. After the procedure, the second
        measurement will be obtained by re-applying the other forms except the Patient Information
        Form. The data will be analyzed using the SPSS 23 program. Shapiro Wilk test, t test,
        Mann-Whitney U test, Wilcoxon test and Chi-square analysis will be used in the analysis of
        the data.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Single (Participant)
  measure: Visual Analog Scale -Pain
  time frame: 1 hours later
  description: Patients are asked to show the intensity of pain on a 10 cm long vertical or horizontal line during activity or rest. It has numbered shapes ranging from 1-10. The line has 0 at the beginning and 10 at the end. 10 means unbearable pain, 0 means no pain. The VAS scale is frequently used in the evaluation of pain severity. While the patient marks the pain he/she has felt on this line, each point marked is measured in cm
  measure: Visual Analog Scale - Fear
  time frame: 1 hours later
  description: Patients are asked to show the intensity of fear on a 10 cm long vertical or horizontal line during activity or rest. It has numbered shapes ranging from 1-10. The line has 0 at the beginning and 10 at the end. 10 means unbearable fear, 0 means no fear. The VAS scale is frequently used in the evaluation of fear severity. While the patient marks the fear he/she has felt on this line, each marked point is measured in cm
  measure: Visual Analog Scale -Anxiety
  time frame: 1 hours later
  description: Patients are asked to show the intensity of anxiety on a 10 cm long horizontal line during activity or rest. The line has 0 at the beginning and 10 at the end. 10 means unbearable pain, 0 means no pain. VAS is frequently used in the evaluation of pain intensity. While the patient marks the anxiety he/she has felt on this line, each marked point is measured in cm
  measure: State-Trait Anxiety Inventory
  time frame: 1 hours later
  description: Developed by Spielberg et al. (1970) to measure the state and trait anxiety levels of individuals, the scale, which consists of two parts and the English name is Speilberg's State-Trait Anxiety Inventory (STAI), is a self-tested reliability and validity study in Turkish by Öner and Le Compte (1977). assessment scale (37-38) In this study, the part of the scale measuring trait anxiety was used to determine the trait anxiety levels of the patients. Trait Anxiety Inventory is a 4-point Likert-type with 20 items and is scored as "never": 1, "a little": 2, "a lot": 3, "completely": 4, according to the severity of the feelings, thoughts or behaviors expressed by the items. . There are direct or reverse scored statements in the scale.
  arm group label: Virtual Reality
  arm group type: Experimental
  description: virtual glasses will be applied
  arm group label: Control
  arm group type: No Intervention
  description: no application will be made
  intervention type: Behavioral
  intervention name: Virtual Reality
  description: Virtual Reality
  arm group label: Virtual Reality
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Gülcan B.TURAN
  role: Principal Investigator
  affiliation: Firat University
  last name: Gülcan B.TURAN
  phone: 05065576086
  email: glcnbah@hotmail.com
  last name: Mukadder Mollaoğlu
  phone: 506 557 60 86
  email: mollaoglumukadder@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Ataturk University
  investigator full name: gülcan bahcecioğlu
  investigator title: Principal Investigator
  sharing ipd: No