<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/NCT04436185</url>
  </required_header>
  <id_info>
    <org_study_id>interventional</org_study_id>
    <nct_id>NCT04436185</nct_id>
  </id_info>
  <brief_title>Effectiveness of Different Non-pharmacological Methods in Pain Management During Vaccination.</brief_title>
  <official_title>Conducted to Determine and Compare the Effectiveness of Different Non-pharmacological Methods in Pain Management During Vaccination.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Inonu University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Inonu 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>
      Aim: This study was conducted to determine and compare the effectiveness of different&#xD;
      non-pharmacological methods in pain management during vaccination.&#xD;
&#xD;
      Methods: This randomized experimental study with placebo and control groups was conducted&#xD;
      with 175 infants assigned to the ShotBlocker® (n = 35), ShotBlocker®-placebo (n = 35),&#xD;
      sucrose (n = 35), sucrose-placebo (n = 35) and control (n = 35) groups. The pain levels of&#xD;
      the infants were determined by blind assessors (nurses, parents, and observer) using the&#xD;
      Neonatal Infant Pain Scale (NIPS) before and during vaccination.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2019</start_date>
  <completion_date type="Actual">September 30, 2019</completion_date>
  <primary_completion_date type="Actual">August 30, 2019</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>This study was designed as a randomized experimental study with placebo and control groups in order to compare the effects of ShotBlocker® and sucrose on pain reduction during vaccine injections.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>In the study, a multi-stage randomization method was used as follows: 1) random selection of the family health centres in the city in which the research was conducted; 2) selection of the mothers and infants to be included in the study at each centre; and 3) selection of the groups to which the participants were assigned using a computer-based block randomization method (https://www.randomizer.org). The infants, randomized via a computer system, were assigned to the ShotBlocker® group (n= 35), ShotBlocker®-placebo group (n = 35), sucrose group (n = 35), sucrose-placebo group (n = 35), or the control group (n=35).</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Neonatal Infant Pain Scale (NIPS)</measure>
    <time_frame>10 minutes</time_frame>
    <description>NIPS is a valid behavioural instrument that can be used to assess infants' response to pain. NIPS includes six behavioural responses to pain: facial expression, crying, breathing patterns, arms, legs, and state of wakefulness. The total pain scores range from 0 to 7. While the internal consistency of the original NIPS is within the range of .87 to .95, the internal consistency of the Turkish version is .83</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">175</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Characteristics of newborns included</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Characteristics of newborns included in the randomized controll</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intraclass Correlation between the NIPS Score of Parent, Nurse</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intraclass Correlation between the NIPS Score of Parent, Nurse</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Comparisons of procedural pain scores among groups</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Comparisons of procedural pain scores among groups</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Comparisons of procedural pain</intervention_name>
    <description>This randomized experimental study with placebo and control groups</description>
    <arm_group_label>Comparisons of procedural pain scores among groups</arm_group_label>
    <arm_group_label>Intraclass Correlation between the NIPS Score of Parent, Nurse</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Born at full term&#xD;
&#xD;
          -  No infection, redness, deteriorated skin integrity, or nerve damage in the area of&#xD;
             application&#xD;
&#xD;
          -  Had not undergone any clinical injection.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Infants who have applied analgesics before the vaccination&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>8 Weeks</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>İnonu Üniversity</name>
      <address>
        <city>Malatya</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>June 16, 2020</last_update_submitted>
  <last_update_submitted_qc>June 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Inonu University</investigator_affiliation>
    <investigator_full_name>Emriye Hilal Yayan</investigator_full_name>
    <investigator_title>associate professor</investigator_title>
  </responsible_party>
  <keyword>pain</keyword>
  <keyword>infants</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04436185
org study id: interventional
nct id: NCT04436185
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Aim: This study was conducted to determine and compare the effectiveness of different
      non-pharmacological methods in pain management during vaccination.

      Methods: This randomized experimental study with placebo and control groups was conducted
      with 175 infants assigned to the ShotBlocker® (n = 35), ShotBlocker®-placebo (n = 35),
      sucrose (n = 35), sucrose-placebo (n = 35) and control (n = 35) groups. The pain levels of
      the infants were determined by blind assessors (nurses, parents, and observer) using the
      Neonatal Infant Pain Scale (NIPS) before and during vaccination.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This study was designed as a randomized experimental study with placebo and control groups in order to compare the effects of ShotBlocker® and sucrose on pain reduction during vaccine injections.
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: In the study, a multi-stage randomization method was used as follows: 1) random selection of the family health centres in the city in which the research was conducted; 2) selection of the mothers and infants to be included in the study at each centre; and 3) selection of the groups to which the participants were assigned using a computer-based block randomization method (https://www.randomizer.org). The infants, randomized via a computer system, were assigned to the ShotBlocker® group (n= 35), ShotBlocker®-placebo group (n = 35), sucrose group (n = 35), sucrose-placebo group (n = 35), or the control group (n=35).
measure: Neonatal Infant Pain Scale (NIPS)
time frame: 10 minutes
description: NIPS is a valid behavioural instrument that can be used to assess infants' response to pain. NIPS includes six behavioural responses to pain: facial expression, crying, breathing patterns, arms, legs, and state of wakefulness. The total pain scores range from 0 to 7. While the internal consistency of the original NIPS is within the range of .87 to .95, the internal consistency of the Turkish version is .83
arm group label: Characteristics of newborns included
arm group type: No Intervention
description: Characteristics of newborns included in the randomized controll
arm group label: Intraclass Correlation between the NIPS Score of Parent, Nurse
arm group type: Experimental
description: Intraclass Correlation between the NIPS Score of Parent, Nurse
arm group label: Comparisons of procedural pain scores among groups
arm group type: Experimental
description: Comparisons of procedural pain scores among groups
intervention type: Behavioral
intervention name: Comparisons of procedural pain
description: This randomized experimental study with placebo and control groups
arm group label: Comparisons of procedural pain scores among groups
arm group label: Intraclass Correlation between the NIPS Score of Parent, Nurse
criteria: 
gender: All
minimum age: N/A
maximum age: 8 Weeks
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Inonu University
investigator full name: Emriye Hilal Yayan
investigator title: associate professor
sharing ipd: No