<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/NCT04421430</url>
  </required_header>
  <id_info>
    <org_study_id>2017-10/9</org_study_id>
    <nct_id>NCT04421430</nct_id>
  </id_info>
  <brief_title>Nonpharmacological Methods for Children in Procedural Pain</brief_title>
  <official_title>The Effect of Three Different Methods on Venipuncture Pain and Anxiety in Children: Distraction Cards, Virtual Reality, and Buzzy® (Randomized Controlled Trial)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istanbul Medeniyet University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istanbul Medeniyet University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The aim of this study was to determine the effect of the distraction cards, virtual reality&#xD;
      and Buzzy® methods on venipuncture pain and anxiety 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, such as distraction&#xD;
      cards, virtual reality and Buzzy®, can be used especially in acute settings.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 16, 2017</start_date>
  <completion_date type="Actual">August 14, 2018</completion_date>
  <primary_completion_date type="Actual">May 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. Literature shows that age, gender, and fear are three factors affecting procedural pain and anxiety in children (Ball, Bindler, &amp; Cowen, 2010; Twycross, 2009). Therefore, 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. The blocks were repeated five times in each group (2X2X2X5), and 40 participants were assigned to each. The sealed envelope method was used to randomly assign participants to the groups.</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 (in cm) 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 WB-FACES was developed by Wong and Baker in 1981 and revised in 1983. 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 (0 = very happy/no pain, 5 = the worst pain imaginable). The first face is a happy face representing &quot;no pain&quot; (0) while the last face is a crying face representing &quot;the worst pain imaginable&quot; (5). 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 by McMurtry et al. (2011) to measure fear and anxiety in children. It consists of five facial expressions that represent a range from neutral (0) to extreme fear (4). Both researchers and family members can use the CFS to measure fear and anxiety in children before and during procedures</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">160</enrollment>
  <condition>Procedural Pain</condition>
  <condition>Procedural Anxiety</condition>
  <arm_group>
    <arm_group_label>Distraction cards group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Distraction cards was applied to the children in this group during the venipuncture procedure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Virtual reality group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Virtual reality intervention was applied to the children in this group during the venipuncture procedure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Buzzy® group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Buzzy® was applied to the children in this group during the venipuncture procedure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group received the routine venipuncture procedure and did not receive any other non-pharmacological intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Distraction cards</intervention_name>
    <description>The distraction cards contain various hidden pictures and patterns which are visible only when looked at carefully. During a procedure, the child is expected to focus on the cards and answer the questions asked about what they see in them. Just before the venipuncture, the researcher showed the distraction cards participants the distraction cards and asked them to check them and then asked them questions about what they saw on the cards and kept asking questions until the end of the venipuncture. The distraction cards intervention and venipuncture were terminated at the same time.</description>
    <arm_group_label>Distraction cards group</arm_group_label>
    <other_name>Flippits1, MMJ Labs, Atlanta, Georgia, ABD</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Virtual reality</intervention_name>
    <description>The virtual reality participants put on the virtual reality glasses and headsets about two minutes before the venipuncture and watched the 3D Dinosaur Animation movie throughout the procedure. The virtual reality intervention and venipuncture were terminated at the same time.</description>
    <arm_group_label>Virtual reality group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Buzzy</intervention_name>
    <description>Buzzy® applies high frequency vibration and concentrated cold at injection site for procedural pain management and distraction before the shot in children and adults. Buzzy® was placed on the injection site (antecubital fossa) of the Buzzy® participants, and cold application and vibration was turned on 60 seconds before the procedure. After the 60 seconds, the nurse moved Buzzy® about 3 cm above the injection site and applied a tourniquet and performed the procedure. Buzzy® was on throughout the procedure. The Buzzy® intervention and venipuncture were terminated at the same time.</description>
    <arm_group_label>Buzzy® group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Due to undergo venipuncture for blood testing&#xD;
&#xD;
          -  Suitable for venipuncture at antecubital location using a 21 Gauge X 1.5 inch needle&#xD;
&#xD;
          -  Due to undergo venipuncture under the same environmental conditions (phlebotomy seat,&#xD;
             heat, light, noise, etc.)&#xD;
&#xD;
          -  Due to undergo venipuncture at the first attempt&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Children;&#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&#xD;
&#xD;
          -  had a history of sedative, analgesic or narcotic use within 24 hours before admission&#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 Ozdemir, 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>
  <reference>
    <citation>Ball, J. W., Bindler, R. C., &amp;Cowen, K. J. (2010). Child Health Nursing: Partnering withak Children and Families. (2 th ed.) London: Pearson Education (Chapter 2).</citation>
  </reference>
  <reference>
    <citation>Twycross A. (2009). Managing pain in children. In: Dowden, S. J., &amp; Bruce, E., (eds.). A Clinical Guide (pp. 42-49). New Jersey: Blackwell Publishing Ltd.</citation>
  </reference>
  <reference>
    <citation>Wong DL, Baker CM. Pain in children: comparison of assessment scales. Pediatr Nurs. 1988 Jan-Feb;14(1):9-17. No abstract available.</citation>
    <PMID>3344163</PMID>
  </reference>
  <reference>
    <citation>McMurtry CM, Noel M, Chambers CT, McGrath PJ. Children's fear during procedural pain: preliminary investigation of the Children's Fear Scale. Health Psychol. 2011 Nov;30(6):780-8. doi: 10.1037/a0024817. Epub 2011 Aug 1.</citation>
    <PMID>21806301</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 4, 2020</last_update_submitted>
  <last_update_submitted_qc>June 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istanbul Medeniyet University</investigator_affiliation>
    <investigator_full_name>Aynur Aytekin Ozdemir</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Anxiety</keyword>
  <keyword>Children</keyword>
  <keyword>Nursing</keyword>
  <keyword>Acute pain management</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>


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/NCT04421430
org study id: 2017-10/9
nct id: NCT04421430
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of this study was to determine the effect of the distraction cards, virtual reality
      and Buzzy® methods on venipuncture pain and anxiety 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, such as distraction
      cards, virtual reality and Buzzy®, can be used especially in acute settings.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants were randomized into the experimental and control groups using a block randomization method. Literature shows that age, gender, and fear are three factors affecting procedural pain and anxiety in children (Ball, Bindler, & Cowen, 2010; Twycross, 2009). Therefore, 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. The blocks were repeated five times in each group (2X2X2X5), and 40 participants were assigned to each. The sealed envelope method was used to randomly assign participants to the groups.
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 (in cm) 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 WB-FACES was developed by Wong and Baker in 1981 and revised in 1983. 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 (0 = very happy/no pain, 5 = the worst pain imaginable). 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 by McMurtry et al. (2011) to measure fear and anxiety in children. It consists of five facial expressions that represent a range from neutral (0) to extreme fear (4). Both researchers and family members can use the CFS to measure fear and anxiety in children before and during procedures
arm group label: Distraction cards group
arm group type: Experimental
description: Distraction cards was applied to the children in this group during the venipuncture procedure.
arm group label: Virtual reality group
arm group type: Experimental
description: Virtual reality intervention was applied to the children in this group during the venipuncture procedure.
arm group label: Buzzy® group
arm group type: Experimental
description: Buzzy® was applied to the children in this group during the venipuncture procedure.
arm group label: Control group
arm group type: No Intervention
description: The control group received the routine venipuncture procedure and did not receive any other non-pharmacological intervention.
intervention type: Other
intervention name: Distraction cards
description: The distraction cards contain various hidden pictures and patterns which are visible only when looked at carefully. During a procedure, the child is expected to focus on the cards and answer the questions asked about what they see in them. Just before the venipuncture, the researcher showed the distraction cards participants the distraction cards and asked them to check them and then asked them questions about what they saw on the cards and kept asking questions until the end of the venipuncture. The distraction cards intervention and venipuncture were terminated at the same time.
arm group label: Distraction cards group
other name: Flippits1, MMJ Labs, Atlanta, Georgia, ABD
intervention type: Other
intervention name: Virtual reality
description: The virtual reality participants put on the virtual reality glasses and headsets about two minutes before the venipuncture and watched the 3D Dinosaur Animation movie throughout the procedure. The virtual reality intervention and venipuncture were terminated at the same time.
arm group label: Virtual reality group
intervention type: Other
intervention name: Buzzy
description: Buzzy® applies high frequency vibration and concentrated cold at injection site for procedural pain management and distraction before the shot in children and adults. Buzzy® was placed on the injection site (antecubital fossa) of the Buzzy® participants, and cold application and vibration was turned on 60 seconds before the procedure. After the 60 seconds, the nurse moved Buzzy® about 3 cm above the injection site and applied a tourniquet and performed the procedure. Buzzy® was on throughout the procedure. The Buzzy® intervention and venipuncture were terminated at the same time.
arm group label: Buzzy® group
criteria: 
gender: All
minimum age: 7 Years
maximum age: 12 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Aynur Aytekin Ozdemir, PhD
role: Principal Investigator
affiliation: Istanbul Medeniyet University
facility: 
country: Turkey
citation: Ball, J. W., Bindler, R. C., &Cowen, K. J. (2010). Child Health Nursing: Partnering withak Children and Families. (2 th ed.) London: Pearson Education (Chapter 2).
citation: Twycross A. (2009). Managing pain in children. In: Dowden, S. J., & Bruce, E., (eds.). A Clinical Guide (pp. 42-49). New Jersey: Blackwell Publishing Ltd.
citation: Wong DL, Baker CM. Pain in children: comparison of assessment scales. Pediatr Nurs. 1988 Jan-Feb;14(1):9-17. No abstract available.
PMID: 3344163
citation: McMurtry CM, Noel M, Chambers CT, McGrath PJ. Children's fear during procedural pain: preliminary investigation of the Children's Fear Scale. Health Psychol. 2011 Nov;30(6):780-8. doi: 10.1037/a0024817. Epub 2011 Aug 1.
PMID: 21806301
responsible party type: Principal Investigator
investigator affiliation: Istanbul Medeniyet University
investigator full name: Aynur Aytekin Ozdemir
investigator title: Associate Professor
mesh term: Pain, Procedural
mesh term: Anxiety Disorders
sharing ipd: No
ipd description: It will be shared after the article is published.