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/NCT06011668</url>
    </required_header>
    <id_info>
      <org_study_id>SKURT-001</org_study_id>
      <nct_id>NCT06011668</nct_id>
    </id_info>
    <brief_title>EFFECT OF DISTRACTION METHODS ON PAIN AND ANXIETY DURING INTRAMUSCULAR INJECTION IN CHILDREN</brief_title>
    <official_title>THE EFFECT OF DISTRACTION METHODS ON PAIN AND ANXIETY DURING INTRAMUSCULAR INJECTION IN CHILDREN AGED 6-12 YEARS</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Mersin University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Mersin 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>
        This thesis study was conducted in an unblinded, randomized controlled experimental manner in&#xD;
        order to analyze the effect of attention-drawing methods that can be used during&#xD;
        intramuscular injection in children on pain and anxiety.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Data were collected in the Pediatric Emergency Injection Unit of Mersin City Training and&#xD;
        Research Hospital between October and December 2021. Children aged 6-12 years were included&#xD;
        in the study. In the study, the sample was divided into four groups. The study consisted of&#xD;
        180 children, 45 children in each group. Using the randomization program, it was determined&#xD;
        which sample group the children would be included in.&#xD;
  &#xD;
        In the study, video game playing, kaleidoscope and virtual reality glasses were used as a&#xD;
        distraction method for the experimental group. Intramuscular injection (IM) was applied to&#xD;
        the control group without any application. The research implementation period lasted an&#xD;
        average of one minute. Required ethical permissions were obtained prior to the research.&#xD;
        Wong-Baker Faces Pain Scale (WBFPRS) was used to measure pain level and Child Fear Scale&#xD;
        (CFS) was used to measure anxiety level in the study. Explanatory information about the&#xD;
        application to be made to the children and their parents was given by the researcher, and the&#xD;
        consent form was signed by informing them voluntarily. The research data were collected by&#xD;
        the researcher by interviewing the children face to face. In line with the data obtained in&#xD;
        the study, it was concluded that the descriptive characteristics of the children in the&#xD;
        experimental and control groups were similar (p&gt;0.05). It was concluded that playing video&#xD;
        games, kaleidoscope, and virtual reality glasses, among the distraction methods applied in&#xD;
        the study, reduced pain and anxiety. It is expected that techniques that reduce pain and&#xD;
        anxiety when intramuscular injections are given to children in nursing practices will be used&#xD;
        in practice and that these practices will be included in the training of nurses.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">October 15, 2021</start_date>
    <completion_date type="Actual">December 15, 2021</completion_date>
    <primary_completion_date type="Actual">October 15, 2021</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>Pain was measured by Wong- Baker Faces Pain Scale</measure>
      <time_frame>at 1st minute before the procedure</time_frame>
      <description>The scale, which was developed by Wong and Baker in 1981 and renewed in 1983, is one of the most common methods used in pain assessment. The use of the scale is suitable for 3 years old and above. Before using the scale, the pain level of the statements on the scale should be explained to the child.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pain was measured by Wong- Baker Faces Pain Scale</measure>
      <time_frame>during the procedure</time_frame>
      <description>The scale, which was developed by Wong and Baker in 1981 and renewed in 1983, is one of the most common methods used in pain assessment. The use of the scale is suitable for 3 years old and above. Before using the scale, the pain level of the statements on the scale should be explained to the child.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pain was measured by Wong- Baker Faces Pain Scale</measure>
      <time_frame>at 1st minute after the procedure</time_frame>
      <description>The scale, which was developed by Wong and Baker in 1981 and renewed in 1983, is one of the most common methods used in pain assessment. The use of the scale is suitable for 3 years old and above. Before using the scale, the pain level of the statements on the scale should be explained to the child.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Fear was measured by Child Fear Scale</measure>
      <time_frame>at 1st minute before the procedure</time_frame>
      <description>In this scale, in which neutral anxiety expression is indicated as (0) and high level of anxiety/fear is indicated as (4), there are facial expressions that progress gradually from neutral anxiety expression to high level of anxiety.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Fear was measured by Child Fear Scale</measure>
      <time_frame>during the procedure</time_frame>
      <description>In this scale, in which neutral anxiety expression is indicated as (0) and high level of anxiety/fear is indicated as (4), there are facial expressions that progress gradually from neutral anxiety expression to high level of anxiety.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Fear was measured by Child Fear Scale</measure>
      <time_frame>at 1st minute after the procedure</time_frame>
      <description>In this scale, in which neutral anxiety expression is indicated as (0) and high level of anxiety/fear is indicated as (4), there are facial expressions that progress gradually from neutral anxiety expression to high level of anxiety.</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Actual">180</enrollment>
    <condition>Pain, Acute</condition>
    <condition>Anxiety and Fear</condition>
    <arm_group>
      <arm_group_label>distraction method</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>video game playing</description>
    </arm_group>
    <arm_group>
      <arm_group_label>distraction</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>kaleidoscope</description>
    </arm_group>
    <arm_group>
      <arm_group_label>distraction methods</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>virtual reality glasses</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>video game playing, kaleidoscope and virtual reality glasses</intervention_name>
      <description>This thesis study was conducted with randomized controlled methods for control in order to analyze the effect of drawing attention to different directions during intramuscular use in countries to what extent the methods of drawing attention to pain and anxiety.</description>
      <arm_group_label>distraction</arm_group_label>
      <arm_group_label>distraction method</arm_group_label>
      <arm_group_label>distraction methods</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Children between the ages of 6-12 and their families who speak Turkish and accepted&#xD;
               the voluntary informed consent form verbally and in writing.&#xD;
  &#xD;
            -  Children who do not have a chronic disease (Children with chronic diseases such as DM,&#xD;
               asthma, hypertension, meningitis, epilepsy, etc. will not be included in the study as&#xD;
               their response levels to pain will vary.)&#xD;
  &#xD;
            -  Children who have not taken an analgesic drug in the last 6 hours&#xD;
  &#xD;
            -  No physical or mental illness&#xD;
  &#xD;
            -  Children who have no suspicion of covid 19 transmission in their family or themselves&#xD;
  &#xD;
            -  Children whose vital signs are in parameters suitable for their age will be taken.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Children who did not accept the voluntary informed consent form verbally and in&#xD;
               writing&#xD;
  &#xD;
            -  Children with chronic diseases (Children with chronic diseases such as DM, asthma,&#xD;
               hypertension, meningitis, epilepsy, etc. will not be included in the study as their&#xD;
               response levels to pain will vary.)&#xD;
  &#xD;
            -  Children who have taken an analgesic drug in the past 6 hours&#xD;
  &#xD;
            -  Those who have a suspected covid 19 transmission in their family or themselves&#xD;
  &#xD;
            -  Children with any physical or mental illness will not be included.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>6 Years</minimum_age>
      <maximum_age>12 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Senem Merve KURT</name>
        <address>
          <city>Mersin</city>
          <state>Merkez</state>
          <zip>33010</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 12, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Mersin University</investigator_affiliation>
      <investigator_full_name>Senem Merve KURT</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Pain</keyword>
    <keyword>Anxiety</keyword>
    <keyword>Distraction</keyword>
    <keyword>Children</keyword>
    <keyword>Intramuscular injection</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Acute Pain</mesh_term>
      <mesh_term>Anxiety Disorders</mesh_term>
    </condition_browse>
    <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/NCT06011668
  org study id: SKURT-001
  nct id: NCT06011668
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This thesis study was conducted in an unblinded, randomized controlled experimental manner in
        order to analyze the effect of attention-drawing methods that can be used during
        intramuscular injection in children on pain and anxiety.
  Data were collected in the Pediatric Emergency Injection Unit of Mersin City Training and
        Research Hospital between October and December 2021. Children aged 6-12 years were included
        in the study. In the study, the sample was divided into four groups. The study consisted of
        180 children, 45 children in each group. Using the randomization program, it was determined
        which sample group the children would be included in.
  
        In the study, video game playing, kaleidoscope and virtual reality glasses were used as a
        distraction method for the experimental group. Intramuscular injection (IM) was applied to
        the control group without any application. The research implementation period lasted an
        average of one minute. Required ethical permissions were obtained prior to the research.
        Wong-Baker Faces Pain Scale (WBFPRS) was used to measure pain level and Child Fear Scale
        (CFS) was used to measure anxiety level in the study. Explanatory information about the
        application to be made to the children and their parents was given by the researcher, and the
        consent form was signed by informing them voluntarily. The research data were collected by
        the researcher by interviewing the children face to face. In line with the data obtained in
        the study, it was concluded that the descriptive characteristics of the children in the
        experimental and control groups were similar (p>0.05). It was concluded that playing video
        games, kaleidoscope, and virtual reality glasses, among the distraction methods applied in
        the study, reduced pain and anxiety. It is expected that techniques that reduce pain and
        anxiety when intramuscular injections are given to children in nursing practices will be used
        in practice and that these practices will be included in the training of nurses.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Pain was measured by Wong- Baker Faces Pain Scale
  time frame: at 1st minute before the procedure
  description: The scale, which was developed by Wong and Baker in 1981 and renewed in 1983, is one of the most common methods used in pain assessment. The use of the scale is suitable for 3 years old and above. Before using the scale, the pain level of the statements on the scale should be explained to the child.
  measure: Pain was measured by Wong- Baker Faces Pain Scale
  time frame: during the procedure
  description: The scale, which was developed by Wong and Baker in 1981 and renewed in 1983, is one of the most common methods used in pain assessment. The use of the scale is suitable for 3 years old and above. Before using the scale, the pain level of the statements on the scale should be explained to the child.
  measure: Pain was measured by Wong- Baker Faces Pain Scale
  time frame: at 1st minute after the procedure
  description: The scale, which was developed by Wong and Baker in 1981 and renewed in 1983, is one of the most common methods used in pain assessment. The use of the scale is suitable for 3 years old and above. Before using the scale, the pain level of the statements on the scale should be explained to the child.
  measure: Fear was measured by Child Fear Scale
  time frame: at 1st minute before the procedure
  description: In this scale, in which neutral anxiety expression is indicated as (0) and high level of anxiety/fear is indicated as (4), there are facial expressions that progress gradually from neutral anxiety expression to high level of anxiety.
  measure: Fear was measured by Child Fear Scale
  time frame: during the procedure
  description: In this scale, in which neutral anxiety expression is indicated as (0) and high level of anxiety/fear is indicated as (4), there are facial expressions that progress gradually from neutral anxiety expression to high level of anxiety.
  measure: Fear was measured by Child Fear Scale
  time frame: at 1st minute after the procedure
  description: In this scale, in which neutral anxiety expression is indicated as (0) and high level of anxiety/fear is indicated as (4), there are facial expressions that progress gradually from neutral anxiety expression to high level of anxiety.
  arm group label: distraction method
  arm group type: Experimental
  description: video game playing
  arm group label: distraction
  arm group type: Experimental
  description: kaleidoscope
  arm group label: distraction methods
  arm group type: Experimental
  description: virtual reality glasses
  intervention type: Device
  intervention name: video game playing, kaleidoscope and virtual reality glasses
  description: This thesis study was conducted with randomized controlled methods for control in order to analyze the effect of drawing attention to different directions during intramuscular use in countries to what extent the methods of drawing attention to pain and anxiety.
  arm group label: distraction
  arm group label: distraction method
  arm group label: distraction methods
  criteria: 
  gender: All
  minimum age: 6 Years
  maximum age: 12 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Mersin University
  investigator full name: Senem Merve KURT
  investigator title: Principal Investigator
  mesh term: Acute Pain
  mesh term: Anxiety Disorders
  sharing ipd: No