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/NCT06038825</url>
    </required_header>
    <id_info>
      <org_study_id>scalp block</org_study_id>
      <nct_id>NCT06038825</nct_id>
    </id_info>
    <brief_title>The Effect of Topical Vibration on Injection Pain in Scalp Block</brief_title>
    <official_title>The Effect of Topical Vibration on Injection Pain in Scalp Block</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Diskapi Teaching and Research Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Diskapi Teaching and Research Hospital</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        In this study; it's aimed to reduce injection pain during the practice of scalp block, which&#xD;
        is used as a method of anesthesia in patients who underwent awake craniotomy surgery. For&#xD;
        this purpose, the investigators used topical vibration stimulation, which is non-invasive&#xD;
        procedure.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Scalp block is an analgesia technique frequently used in neurosurgical procedures. In this&#xD;
        block, while providing adequate anesthesia for surgery, it also helps to preserve&#xD;
        hemodynamics by inhibiting pain sensation. In this block, there is a certain degree of pain&#xD;
        due to multiple injections. The transmission of pain sensation to the cortex is reduced by&#xD;
        costimulating the receptors that transmit the pain sensation with vibration stimulus. In this&#xD;
        study; it was aimed to investigate the effect of topical vibration on injection pain in&#xD;
        participants who received sedoanalgesia with dexmedetomidine in bilateral scalp block&#xD;
        practice.&#xD;
  &#xD;
        In routine clinical practice, bilateral scalp block (local anesthetic injection into greater&#xD;
        occipital, lesser occipital, supratrochlear, supraorbital, auriculotemporal,&#xD;
        zygomaticotemporal nerves) is performed in participants who is sedated. While local&#xD;
        anesthetic is injecting, vibration device (Aprilla brand, giving 6000 vibrations per minute)&#xD;
        will be vibrated for 10 seconds and then local anesthetic will be injected. Meanwhile,&#xD;
        participants' numerical pain scores (NRS) and hemodynamic parameters will be monitored.&#xD;
  &#xD;
        In this study, the NRS scores and hemodynamic variables of the participants will be compared&#xD;
        during the local anesthetic application of each 6 nerves bilaterally and during the&#xD;
        injections of the nerves with and without the use of vibration.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 18, 2023</start_date>
    <completion_date type="Anticipated">December 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 30, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Crossover Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>pain score (NRS)</measure>
      <time_frame>during needling (injection) procedure</time_frame>
      <description>0 ; no pain,10; the worst pain ever possible</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Mean arterial pressure (mmHg)</measure>
      <time_frame>baseline, during needling procedure, 1 min after needling</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Heart Rate (beat/min)</measure>
      <time_frame>baseline, during needling procedure, 1 min after needling</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Analgesia</condition>
    <arm_group>
      <arm_group_label>topical vibration</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>For all patients one half of the scalp was injected with vibration device.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Same patient's other side of the scalp was injected without vibration device.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>topical vibration</intervention_name>
      <description>topical vibration (Aprilla brand, giving 6000 vibrations per minute) is a device for pain relief during injection of local anesthetic.</description>
      <arm_group_label>topical vibration</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  between the ages of 18-75&#xD;
  &#xD;
            -  ASA (American Society of Anesthesiologists) Scoring I-III&#xD;
  &#xD;
            -  Cases in which scalp block will be applied&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  ASA score IV&#xD;
  &#xD;
                 -  Uncooperative&#xD;
  &#xD;
                 -  Known allergy to any of the study drugs&#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>nur yilmaz, specialist</last_name>
      <role>Principal Investigator</role>
      <affiliation>Ankara Etlik City Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Derya Ozkan, professor</last_name>
      <phone>5425843638</phone>
      <email>derya_z@yahoo.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Ankara Etlik City Hospital</name>
        <address>
          <city>Ankara</city>
          <country>Turkey</country>
        </address>
      </facility>
      <contact>
        <last_name>derya ozkan, professor</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <reference>
      <citation>Kuwahara H, Ogawa R. Using a Vibration Device to Ease Pain During Facial Needling and Injection. Eplasty. 2016 Feb 4;16:e9. eCollection 2016.</citation>
      <PMID>26933468</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>September 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 14, 2023</last_update_submitted>
    <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Diskapi Teaching and Research Hospital</investigator_affiliation>
      <investigator_full_name>derya özkan</investigator_full_name>
      <investigator_title>professor medical doctor</investigator_title>
    </responsible_party>
    <keyword>scalp clock</keyword>
    <keyword>awake craniotomy</keyword>
    <keyword>vibration</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/NCT06038825
  org study id: scalp block
  nct id: NCT06038825
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  In this study; it's aimed to reduce injection pain during the practice of scalp block, which
        is used as a method of anesthesia in patients who underwent awake craniotomy surgery. For
        this purpose, the investigators used topical vibration stimulation, which is non-invasive
        procedure.
  Scalp block is an analgesia technique frequently used in neurosurgical procedures. In this
        block, while providing adequate anesthesia for surgery, it also helps to preserve
        hemodynamics by inhibiting pain sensation. In this block, there is a certain degree of pain
        due to multiple injections. The transmission of pain sensation to the cortex is reduced by
        costimulating the receptors that transmit the pain sensation with vibration stimulus. In this
        study; it was aimed to investigate the effect of topical vibration on injection pain in
        participants who received sedoanalgesia with dexmedetomidine in bilateral scalp block
        practice.
  
        In routine clinical practice, bilateral scalp block (local anesthetic injection into greater
        occipital, lesser occipital, supratrochlear, supraorbital, auriculotemporal,
        zygomaticotemporal nerves) is performed in participants who is sedated. While local
        anesthetic is injecting, vibration device (Aprilla brand, giving 6000 vibrations per minute)
        will be vibrated for 10 seconds and then local anesthetic will be injected. Meanwhile,
        participants' numerical pain scores (NRS) and hemodynamic parameters will be monitored.
  
        In this study, the NRS scores and hemodynamic variables of the participants will be compared
        during the local anesthetic application of each 6 nerves bilaterally and during the
        injections of the nerves with and without the use of vibration.
  allocation: Non-Randomized
  intervention model: Crossover Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: pain score (NRS)
  time frame: during needling (injection) procedure
  description: 0 ; no pain,10; the worst pain ever possible
  measure: Mean arterial pressure (mmHg)
  time frame: baseline, during needling procedure, 1 min after needling
  measure: Heart Rate (beat/min)
  time frame: baseline, during needling procedure, 1 min after needling
  arm group label: topical vibration
  arm group type: Active Comparator
  description: For all patients one half of the scalp was injected with vibration device.
  arm group label: control
  arm group type: No Intervention
  description: Same patient's other side of the scalp was injected without vibration device.
  intervention type: Device
  intervention name: topical vibration
  description: topical vibration (Aprilla brand, giving 6000 vibrations per minute) is a device for pain relief during injection of local anesthetic.
  arm group label: topical vibration
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: nur yilmaz, specialist
  role: Principal Investigator
  affiliation: Ankara Etlik City Hospital
  last name: Derya Ozkan, professor
  phone: 5425843638
  email: derya_z@yahoo.com
  facility: 
  contact: 
  country: Turkey
  citation: Kuwahara H, Ogawa R. Using a Vibration Device to Ease Pain During Facial Needling and Injection. Eplasty. 2016 Feb 4;16:e9. eCollection 2016.
  PMID: 26933468
  responsible party type: Principal Investigator
  investigator affiliation: Diskapi Teaching and Research Hospital
  investigator full name: derya özkan
  investigator title: professor medical doctor
  sharing ipd: No