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/NCT06018909</url>
    </required_header>
    <id_info>
      <org_study_id>2018-3/20</org_study_id>
      <nct_id>NCT06018909</nct_id>
    </id_info>
    <brief_title>The Effect of Cognitive-Behavioral Intervention Package on Procedural Pain and Anxiety in Children</brief_title>
    <official_title>The Effect of Cognitive-Behavioral Intervention Package on Peripheral Venous Cannulation Pain and Anxiety in Children: A Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Aynur Aytekin Ozdemir</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Istanbul Medeniyet 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 study investigated the effect of cognitive-behavioral interventions package (CBIP) on&#xD;
        pain and anxiety related to peripheral venous cannulation (PVC) in children aged 7-12 years.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The International Guide to Pediatric Anesthesia (Good Practice in Postoperative and&#xD;
        Procedural Pain) recommends pharmacological and nonpharmacological methods to effectively&#xD;
        manage and prevent acute procedural pain in children. Nonpharmacological methods alone or in&#xD;
        combination with pharmacological methods help reduce pain, and therefore, have become popular&#xD;
        especially in recent years. For pain management, nonpharmacological methods are easy to use,&#xD;
        and cost- and time-effective methods with no side effects. Studies have evaluated a large&#xD;
        number of pharmacological and nonpharmacological interventions for procedural pain management&#xD;
        in children. However, most of those interventions are not used by healthcare professionals&#xD;
        because they are expensive, time-consuming or hard to use. Therefore, easy-to-use, practical,&#xD;
        non-invasive, cost-effective, and reusable nonpharmacological methods can be used especially&#xD;
        in acute settings. Cognitive-behavioral interventions, one of the non-pharmacological methods&#xD;
        used to minimize pain and anxiety related to painful medical procedures in children are&#xD;
        promising.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">March 29, 2018</start_date>
    <completion_date type="Actual">June 28, 2019</completion_date>
    <primary_completion_date type="Actual">October 31, 2018</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Participants were randomized into the experimental and control groups using a block randomization method. The variables of age (7-9 and 10-12 years), gender (girls and boys), and fear of procedure (yes and no) were used for block randomization.</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Single (Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Visual Analog Scale: VAS</measure>
      <time_frame>Through painful procedure completion, an average of 10 minutes</time_frame>
      <description>The VAS is used to measure and monitor pain intensity. VAS is a 10 cm or 100 mm long horizontal or vertical line with anchor statements &quot;no pain or pain at its least&quot; at the left-most end and &quot;unbearable pain or worst pain imaginable&quot; at the right-most end. The participant is asked to mark a point on the line that best represents their pain level. The VAS score is determined by measuring the distance of the mark from the left end of the line. VAS is an easy-to-understand and easy-to-measure scale for children aged 7 and over.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Wong-Baker FACES Pain Rating Scale: WB-FACES</measure>
      <time_frame>Through painful procedure completion, an average of 10 minutes</time_frame>
      <description>The scale is used to diagnose pain in children aged 3-18 years. It consists of six facial expressions, each one representing an increasing degree of pain scored on a scale 0 to 5 from left to right. The first face is a happy face representing &quot;no pain=0&quot; while the last face is a crying face representing &quot;the worst pain imaginable=5&quot;. Higher scores indicate low pain tolerance. Participants are asked to choose the facial expression that best represents their pain.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Children's Fear Scale: CFS</measure>
      <time_frame>Through painful procedure completion, an average of 10 minutes</time_frame>
      <description>The CFS was developed to measure fear and anxiety in children. It consists of five facial expressions that represent a range from neutral to extreme fear. It is scored between 0 and 4. Both researchers and family members can use the CFS to measure fear and anxiety in children before and during procedures.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>State-Trait Anxiety Inventory for Children-State Form (STAIC-State)</measure>
      <time_frame>Through painful procedure completion, an average of 10 minutes</time_frame>
      <description>STAIC was designed as a research tool for the study of anxiety in 9- to 12-year-old children as well as in younger or older children depending on their reading ability. The widely used STAIC-State Form includes 20-item self-report scale situational variation. In the STAIC-State Form, the children were asked to evaluate how they felt &quot;that moment&quot; and mark one of the relevant choices. When the presence of these feelings is stated as &quot;much&quot; by the child, the highest score is 3; and when it is not stated, the lowest score is 1.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">80</enrollment>
    <condition>Procedural Anxiety</condition>
    <condition>Procedural Pain</condition>
    <arm_group>
      <arm_group_label>Cognitive-Behavioral Interventions Package Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants received CBIP. CBIP included procedural preparation and information, distraction, suggestions, parent training and positive reinforcement.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>The control group received the routine peripheral venous cannulation procedure.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Cognitive-Behavioral Interventions Package</intervention_name>
      <description>CBIP was developed by researchers in line with the relevant literature according to the developmental characteristics of children. Opinions were obtained from experts in the field of pediatrics or psychiatric nursing regarding CBIP. CBIP consisted of cognitive and behavioral practices to prevent/reduce procedural pain and anxiety.</description>
      <arm_group_label>Cognitive-Behavioral Interventions Package Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  being between the ages of 7 to 12 years&#xD;
  &#xD;
            -  be literate&#xD;
  &#xD;
            -  requiring peripheral venous cannulation procedure&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  had chronic diseases&#xD;
  &#xD;
            -  had neuro-developmentally delayed&#xD;
  &#xD;
            -  had visual, audio, or speech impairments&#xD;
  &#xD;
            -  were hospital stay for treatment in the past three years&#xD;
  &#xD;
            -  had a history of sedative, analgesic or narcotic use within 24 hours before procedure&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>7 Years</minimum_age>
      <maximum_age>12 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Aynur Aytekin Özdemir, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Istanbul Medeniyet University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Istanbul Medeniyet University</name>
        <address>
          <city>Istanbul</city>
          <state>Kadıköy</state>
          <zip>34720</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <results_reference>
      <citation>Hsieh YC, Cheng SF, Tsay PK, Su WJ, Cho YH, Chen CW. Effectiveness of Cognitive-behavioral Program on Pain and Fear in School-aged Children Undergoing Intravenous Placement. Asian Nurs Res (Korean Soc Nurs Sci). 2017 Dec;11(4):261-267. doi: 10.1016/j.anr.2017.10.002. Epub 2017 Oct 26.</citation>
      <PMID>29290273</PMID>
    </results_reference>
    <results_reference>
      <citation>McCarthy AM, Cool VA, Hanrahan K. Cognitive behavioral interventions for children during painful procedures: research challenges and program development. J Pediatr Nurs. 1998 Feb;13(1):55-63. doi: 10.1016/S0882-5963(98)80069-9.</citation>
      <PMID>9503767</PMID>
    </results_reference>
    <results_reference>
      <citation>Uman LS, Birnie KA, Noel M, Parker JA, Chambers CT, McGrath PJ, Kisely SR. Psychological interventions for needle-related procedural pain and distress in children and adolescents. Cochrane Database Syst Rev. 2013 Oct 10;(10):CD005179. doi: 10.1002/14651858.CD005179.pub3.</citation>
      <PMID>24108531</PMID>
    </results_reference>
    <results_reference>
      <citation>Uman LS, Chambers CT, McGrath PJ, Kisely S. A systematic review of randomized controlled trials examining psychological interventions for needle-related procedural pain and distress in children and adolescents: an abbreviated cochrane review. J Pediatr Psychol. 2008 Sep;33(8):842-54. doi: 10.1093/jpepsy/jsn031. Epub 2008 Apr 2.</citation>
      <PMID>18387963</PMID>
    </results_reference>
    <results_reference>
      <citation>Yilmaz Kurt F, Aytekin Ozdemir A, Atay S. The Effects of Two Methods on Venipuncture Pain in Children: Procedural Restraint and Cognitive-Behavioral Intervention Package. Pain Manag Nurs. 2020 Dec;21(6):594-600. doi: 10.1016/j.pmn.2019.09.002. Epub 2019 Oct 15.</citation>
      <PMID>31628067</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Istanbul Medeniyet University</investigator_affiliation>
      <investigator_full_name>Aynur Aytekin Ozdemir</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>Anxiety</keyword>
    <keyword>Children</keyword>
    <keyword>Procedural pain</keyword>
    <keyword>Cognitive-behavioral interventions</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pain, Procedural</mesh_term>
      <mesh_term>Anxiety Disorders</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>It will be shared after the article is published.</ipd_description>
    </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/NCT06018909
  org study id: 2018-3/20
  nct id: NCT06018909
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study investigated the effect of cognitive-behavioral interventions package (CBIP) on
        pain and anxiety related to peripheral venous cannulation (PVC) in children aged 7-12 years.
  The International Guide to Pediatric Anesthesia (Good Practice in Postoperative and
        Procedural Pain) recommends pharmacological and nonpharmacological methods to effectively
        manage and prevent acute procedural pain in children. Nonpharmacological methods alone or in
        combination with pharmacological methods help reduce pain, and therefore, have become popular
        especially in recent years. For pain management, nonpharmacological methods are easy to use,
        and cost- and time-effective methods with no side effects. Studies have evaluated a large
        number of pharmacological and nonpharmacological interventions for procedural pain management
        in children. However, most of those interventions are not used by healthcare professionals
        because they are expensive, time-consuming or hard to use. Therefore, easy-to-use, practical,
        non-invasive, cost-effective, and reusable nonpharmacological methods can be used especially
        in acute settings. Cognitive-behavioral interventions, one of the non-pharmacological methods
        used to minimize pain and anxiety related to painful medical procedures in children are
        promising.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Participants were randomized into the experimental and control groups using a block randomization method. The variables of age (7-9 and 10-12 years), gender (girls and boys), and fear of procedure (yes and no) were used for block randomization.
  primary purpose: Supportive Care
  masking: Single (Investigator)
  measure: Visual Analog Scale: VAS
  time frame: Through painful procedure completion, an average of 10 minutes
  description: The VAS is used to measure and monitor pain intensity. VAS is a 10 cm or 100 mm long horizontal or vertical line with anchor statements "no pain or pain at its least" at the left-most end and "unbearable pain or worst pain imaginable" at the right-most end. The participant is asked to mark a point on the line that best represents their pain level. The VAS score is determined by measuring the distance of the mark from the left end of the line. VAS is an easy-to-understand and easy-to-measure scale for children aged 7 and over.
  measure: Wong-Baker FACES Pain Rating Scale: WB-FACES
  time frame: Through painful procedure completion, an average of 10 minutes
  description: The scale is used to diagnose pain in children aged 3-18 years. It consists of six facial expressions, each one representing an increasing degree of pain scored on a scale 0 to 5 from left to right. The first face is a happy face representing "no pain=0" while the last face is a crying face representing "the worst pain imaginable=5". Higher scores indicate low pain tolerance. Participants are asked to choose the facial expression that best represents their pain.
  measure: Children's Fear Scale: CFS
  time frame: Through painful procedure completion, an average of 10 minutes
  description: The CFS was developed to measure fear and anxiety in children. It consists of five facial expressions that represent a range from neutral to extreme fear. It is scored between 0 and 4. Both researchers and family members can use the CFS to measure fear and anxiety in children before and during procedures.
  measure: State-Trait Anxiety Inventory for Children-State Form (STAIC-State)
  time frame: Through painful procedure completion, an average of 10 minutes
  description: STAIC was designed as a research tool for the study of anxiety in 9- to 12-year-old children as well as in younger or older children depending on their reading ability. The widely used STAIC-State Form includes 20-item self-report scale situational variation. In the STAIC-State Form, the children were asked to evaluate how they felt "that moment" and mark one of the relevant choices. When the presence of these feelings is stated as "much" by the child, the highest score is 3; and when it is not stated, the lowest score is 1.
  arm group label: Cognitive-Behavioral Interventions Package Group
  arm group type: Experimental
  description: Participants received CBIP. CBIP included procedural preparation and information, distraction, suggestions, parent training and positive reinforcement.
  arm group label: Control
  arm group type: No Intervention
  description: The control group received the routine peripheral venous cannulation procedure.
  intervention type: Behavioral
  intervention name: Cognitive-Behavioral Interventions Package
  description: CBIP was developed by researchers in line with the relevant literature according to the developmental characteristics of children. Opinions were obtained from experts in the field of pediatrics or psychiatric nursing regarding CBIP. CBIP consisted of cognitive and behavioral practices to prevent/reduce procedural pain and anxiety.
  arm group label: Cognitive-Behavioral Interventions Package Group
  criteria: 
  gender: All
  minimum age: 7 Years
  maximum age: 12 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Aynur Aytekin Özdemir, PhD
  role: Principal Investigator
  affiliation: Istanbul Medeniyet University
  facility: 
  country: Turkey
  citation: Hsieh YC, Cheng SF, Tsay PK, Su WJ, Cho YH, Chen CW. Effectiveness of Cognitive-behavioral Program on Pain and Fear in School-aged Children Undergoing Intravenous Placement. Asian Nurs Res (Korean Soc Nurs Sci). 2017 Dec;11(4):261-267. doi: 10.1016/j.anr.2017.10.002. Epub 2017 Oct 26.
  PMID: 29290273
  citation: McCarthy AM, Cool VA, Hanrahan K. Cognitive behavioral interventions for children during painful procedures: research challenges and program development. J Pediatr Nurs. 1998 Feb;13(1):55-63. doi: 10.1016/S0882-5963(98)80069-9.
  PMID: 9503767
  citation: Uman LS, Birnie KA, Noel M, Parker JA, Chambers CT, McGrath PJ, Kisely SR. Psychological interventions for needle-related procedural pain and distress in children and adolescents. Cochrane Database Syst Rev. 2013 Oct 10;(10):CD005179. doi: 10.1002/14651858.CD005179.pub3.
  PMID: 24108531
  citation: Uman LS, Chambers CT, McGrath PJ, Kisely S. A systematic review of randomized controlled trials examining psychological interventions for needle-related procedural pain and distress in children and adolescents: an abbreviated cochrane review. J Pediatr Psychol. 2008 Sep;33(8):842-54. doi: 10.1093/jpepsy/jsn031. Epub 2008 Apr 2.
  PMID: 18387963
  citation: Yilmaz Kurt F, Aytekin Ozdemir A, Atay S. The Effects of Two Methods on Venipuncture Pain in Children: Procedural Restraint and Cognitive-Behavioral Intervention Package. Pain Manag Nurs. 2020 Dec;21(6):594-600. doi: 10.1016/j.pmn.2019.09.002. Epub 2019 Oct 15.
  PMID: 31628067
  responsible party type: Sponsor-Investigator
  investigator affiliation: Istanbul Medeniyet University
  investigator full name: Aynur Aytekin Ozdemir
  investigator title: Professor
  mesh term: Pain, Procedural
  mesh term: Anxiety Disorders
  sharing ipd: No
  ipd description: It will be shared after the article is published.