<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/NCT04411992</url>
  </required_header>
  <id_info>
    <org_study_id>42432570</org_study_id>
    <nct_id>NCT04411992</nct_id>
  </id_info>
  <brief_title>The Effect of Vibration Stimulation on Intramuscular Injection Pain and Patient Satisfaction: A Single-blind, Randomized Cross-over Study</brief_title>
  <official_title>The Effect of Vibration Stimulation on Intramuscular Injection Pain and Patient Satisfaction: A Single-Blind, Randomized Cross-over Study</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Intramuscular (IM) injection is the most frequently used nursing practice in the clinic.1 16&#xD;
      billion treatments are performed through injection per year all over the world. Approximately&#xD;
      95% of these injections are administered for therapeutic purpose. There is no study result in&#xD;
      the literature on the effect of vibration on pain in the ventrogluteal region in particular.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Intramuscular (IM) injection is the most frequently used nursing practice in the clinic.1 16&#xD;
      billion treatments are performed through injection per year all over the world. Approximately&#xD;
      95% of these injections are administered for therapeutic purpose.&#xD;
&#xD;
      If IM injections are not administered properly, they cause many complications such as&#xD;
      primarily pain and cellulitis, muscular fibrosis and contracture, abscesses, tissue necrosis,&#xD;
      granuloma, hematoma, and nerve injuries.Painful injections may lead to the development of&#xD;
      fear and needle phobia. People are not able to comply with the treatment due to fear and&#xD;
      needle phobia and they may even reject treatment. Pain developing after IM injection may vary&#xD;
      based on drug content, individual factors and injection technique.&#xD;
&#xD;
      It has been reported that patients feel less pain and the other complications decrease when&#xD;
      the correct technique of IM injection is selected. Different pain relief methods such as&#xD;
      local ice application, changing needle before injection and acupressure are employed during&#xD;
      injection. In the literature, mechano-analgesia, which is known as the skin stimulation&#xD;
      methods, is included in pain management in addition to these methods.&#xD;
&#xD;
      One of the mechano-analgesia methods is vibration. The pain-relief mechanism of vibration is&#xD;
      explained with the gate control theory. The theory, which is a similar mechanism used to&#xD;
      obtain pain relief by rubbing an area near an injury, using TENS, or acupuncture. In the&#xD;
      studies, it has been explained by the fact that the sense of touch and vibration obtained&#xD;
      from skin receptors stimulate the intermediary inhibitor neurons in medulla spinalis through&#xD;
      A-β nerve fibres. These neurons reduce the pain level in A-delta and A-C fibres in&#xD;
      transmitting the signal received from skin to the second neuron, the signal cross over&#xD;
      medulla spinalis and rises to brain. There are studies in the literature explaining that pain&#xD;
      is reduced by vibration. Also, the vibration has advantages over other methods such as TENS,&#xD;
      acupuncture as it is a method that is easy to apply, simple, applicable in all hours, and&#xD;
      cheap and does not require any preparation.&#xD;
&#xD;
      Although the results of the related studies have indicated that this new method is effective&#xD;
      in reducing injection pain, the number of studies on this method in the literature is&#xD;
      limited. There is no study result in the literature on the effect of vibration on pain in the&#xD;
      ventrogluteal region in particular.&#xD;
&#xD;
      Purpose of the study The purpose of this study was to assess the effect of vibration&#xD;
      stimulation application in ventrogluteal region on intramuscular injection pain and patient&#xD;
      satisfaction.&#xD;
&#xD;
      The specific study questions were as follows:&#xD;
&#xD;
        1. What are the effects of vibration on intramuscular injection-induced pain?&#xD;
&#xD;
        2. What are the effects of vibration on satisfaction for intramuscular injection?&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 5, 2020</start_date>
  <completion_date type="Anticipated">September 10, 2020</completion_date>
  <primary_completion_date type="Anticipated">September 5, 2020</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>Crossover Assignment</intervention_model>
    <intervention_model_description>Two groups were formed according to crossover design. The groups of the patients were determined according to the randomization list formed by using the following website; www.randomization.com.All the measurement scores were obtained by another researcher blinded to group allocation.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Investigator)</masking>
    <masking_description>All the measurement scores were obtained by another researcher blinded to group allocation.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>the effects of vibration on intramuscular injection-induced pain</measure>
    <time_frame>Three months</time_frame>
    <description>Pain will be measures with Visual Analog Scale (VAS). The scale is composed of a 10-cm vertical or horizontal line, which starts with &quot;No pain&quot; on the one edge and ends with &quot;worst pain&quot; on the other edge. Patients should be informed about the use of VAS very well. Patients are asked to indicate the pain level by marking the appropriate point on the line.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>the effects of vibration on satisfaction for intramuscular injection</measure>
    <time_frame>Three months</time_frame>
    <description>patient satisfaction will be measured with Visual Analog Patient Satisfaction Scale .Visual patient satisfaction scale is combined with the characteristics of the well-known VAS (Visual Analog Scale). It is composed of a 100-mm horizontal line without numbers.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">84</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Allocated to Vibration intervention (1) A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient information form, visual pain form and satisfaction scale were applied before injection application for all of the patients. The height, weight and BMI of the patients will be measured by the attending nurse. Intramuscular antibiotic injection with vibration will be applied to the ventrogluteal region of the patients .</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Allocated to Control intervention (1) B</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The height, weight and BMI of the patients will be measured by the attending nurse. Intramuscular antibiotic injection without vibration will be applied to the ventrogluteal region of the patients.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Allocated to Vibration intervention (2) B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient information form, visual pain form and satisfaction scale were applied before injection application for all of the patients. The height, weight and BMI of the patients will be measured by the attending nurse. Intramuscular antibiotic injection with vibration will be applied to the ventrogluteal region of the patients .</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Allocated to Control intervention (1) A</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The height, weight and BMI of the patients will be measured by the attending nurse. Intramuscular antibiotic injection without vibration will be applied to the ventrogluteal region of the patients.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Vibrating Device</intervention_name>
    <description>The device used for the vibration application was produced to control pain and distract attention by providing vibration of 150 at 183 Hz (9000-11,000/min). The device is used again by being cleaned with 70% alcohol. The device was placed put 3 cm above the injection site. It should be ensured to completely contact with skin. Vibration was applied on the site for 3 minutes before injection</description>
    <arm_group_label>Allocated to Vibration intervention (1) A</arm_group_label>
    <arm_group_label>Allocated to Vibration intervention (2) B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years old and over&#xD;
&#xD;
          -  had no communication problem,&#xD;
&#xD;
          -  had a body mass index (BMI) of 18.5 to 30 kg/m2,&#xD;
&#xD;
          -  not injected in ventrogluteal region in the last two weeks&#xD;
&#xD;
          -  not have any pain, hematoma, necrosis, scar, incision or infection symptoms on skin in&#xD;
             ventrogluteal region&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have ppain, hematoma, necrosis, scar, incision or infection symptoms on skin in&#xD;
             ventrogluteal region&#xD;
&#xD;
          -  injected in ventrogluteal region in the last two weeks&#xD;
&#xD;
          -  not want to participate.&#xD;
&#xD;
          -  body mass index (BMI) of under 18.5 and up 30 kg/m2,&#xD;
&#xD;
          -  have psychological illness&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>June 1, 2020</last_update_submitted>
  <last_update_submitted_qc>June 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istanbul Medeniyet University</investigator_affiliation>
    <investigator_full_name>Berna Dincer</investigator_full_name>
    <investigator_title>Assistant Prof.</investigator_title>
  </responsible_party>
  <keyword>Vibration</keyword>
  <keyword>Pain management</keyword>
  <keyword>satisfaction</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/NCT04411992
org study id: 42432570
nct id: NCT04411992
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Intramuscular (IM) injection is the most frequently used nursing practice in the clinic.1 16
      billion treatments are performed through injection per year all over the world. Approximately
      95% of these injections are administered for therapeutic purpose. There is no study result in
      the literature on the effect of vibration on pain in the ventrogluteal region in particular.
Intramuscular (IM) injection is the most frequently used nursing practice in the clinic.1 16
      billion treatments are performed through injection per year all over the world. Approximately
      95% of these injections are administered for therapeutic purpose.

      If IM injections are not administered properly, they cause many complications such as
      primarily pain and cellulitis, muscular fibrosis and contracture, abscesses, tissue necrosis,
      granuloma, hematoma, and nerve injuries.Painful injections may lead to the development of
      fear and needle phobia. People are not able to comply with the treatment due to fear and
      needle phobia and they may even reject treatment. Pain developing after IM injection may vary
      based on drug content, individual factors and injection technique.

      It has been reported that patients feel less pain and the other complications decrease when
      the correct technique of IM injection is selected. Different pain relief methods such as
      local ice application, changing needle before injection and acupressure are employed during
      injection. In the literature, mechano-analgesia, which is known as the skin stimulation
      methods, is included in pain management in addition to these methods.

      One of the mechano-analgesia methods is vibration. The pain-relief mechanism of vibration is
      explained with the gate control theory. The theory, which is a similar mechanism used to
      obtain pain relief by rubbing an area near an injury, using TENS, or acupuncture. In the
      studies, it has been explained by the fact that the sense of touch and vibration obtained
      from skin receptors stimulate the intermediary inhibitor neurons in medulla spinalis through
      A-β nerve fibres. These neurons reduce the pain level in A-delta and A-C fibres in
      transmitting the signal received from skin to the second neuron, the signal cross over
      medulla spinalis and rises to brain. There are studies in the literature explaining that pain
      is reduced by vibration. Also, the vibration has advantages over other methods such as TENS,
      acupuncture as it is a method that is easy to apply, simple, applicable in all hours, and
      cheap and does not require any preparation.

      Although the results of the related studies have indicated that this new method is effective
      in reducing injection pain, the number of studies on this method in the literature is
      limited. There is no study result in the literature on the effect of vibration on pain in the
      ventrogluteal region in particular.

      Purpose of the study The purpose of this study was to assess the effect of vibration
      stimulation application in ventrogluteal region on intramuscular injection pain and patient
      satisfaction.

      The specific study questions were as follows:

        1. What are the effects of vibration on intramuscular injection-induced pain?

        2. What are the effects of vibration on satisfaction for intramuscular injection?
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Two groups were formed according to crossover design. The groups of the patients were determined according to the randomization list formed by using the following website; www.randomization.com.All the measurement scores were obtained by another researcher blinded to group allocation.
primary purpose: Prevention
masking: Single (Investigator)
masking description: All the measurement scores were obtained by another researcher blinded to group allocation.
measure: the effects of vibration on intramuscular injection-induced pain
time frame: Three months
description: Pain will be measures with Visual Analog Scale (VAS). The scale is composed of a 10-cm vertical or horizontal line, which starts with "No pain" on the one edge and ends with "worst pain" on the other edge. Patients should be informed about the use of VAS very well. Patients are asked to indicate the pain level by marking the appropriate point on the line.
measure: the effects of vibration on satisfaction for intramuscular injection
time frame: Three months
description: patient satisfaction will be measured with Visual Analog Patient Satisfaction Scale .Visual patient satisfaction scale is combined with the characteristics of the well-known VAS (Visual Analog Scale). It is composed of a 100-mm horizontal line without numbers.
arm group label: Allocated to Vibration intervention (1) A
arm group type: Experimental
description: Patient information form, visual pain form and satisfaction scale were applied before injection application for all of the patients. The height, weight and BMI of the patients will be measured by the attending nurse. Intramuscular antibiotic injection with vibration will be applied to the ventrogluteal region of the patients .
arm group label: Allocated to Control intervention (1) B
arm group type: No Intervention
description: The height, weight and BMI of the patients will be measured by the attending nurse. Intramuscular antibiotic injection without vibration will be applied to the ventrogluteal region of the patients.
arm group label: Allocated to Vibration intervention (2) B
arm group type: Experimental
description: Patient information form, visual pain form and satisfaction scale were applied before injection application for all of the patients. The height, weight and BMI of the patients will be measured by the attending nurse. Intramuscular antibiotic injection with vibration will be applied to the ventrogluteal region of the patients .
arm group label: Allocated to Control intervention (1) A
arm group type: No Intervention
description: The height, weight and BMI of the patients will be measured by the attending nurse. Intramuscular antibiotic injection without vibration will be applied to the ventrogluteal region of the patients.
intervention type: Device
intervention name: Vibrating Device
description: The device used for the vibration application was produced to control pain and distract attention by providing vibration of 150 at 183 Hz (9000-11,000/min). The device is used again by being cleaned with 70% alcohol. The device was placed put 3 cm above the injection site. It should be ensured to completely contact with skin. Vibration was applied on the site for 3 minutes before injection
arm group label: Allocated to Vibration intervention (1) A
arm group label: Allocated to Vibration intervention (2) B
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Istanbul Medeniyet University
investigator full name: Berna Dincer
investigator title: Assistant Prof.
sharing ipd: No