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/NCT06023485</url>
    </required_header>
    <id_info>
      <org_study_id>The Effect of Stress Ball Use</org_study_id>
      <secondary_id>KLÜBAP-249</secondary_id>
      <secondary_id>2023-249</secondary_id>
      <secondary_id>2023-249</secondary_id>
      <nct_id>NCT06023485</nct_id>
    </id_info>
    <brief_title>The Effect of Stress Ball Use on Procedural Pain Caused by Subcutaneous Injection in Orthopedic Patients</brief_title>
    <official_title>The Effect of Stress Ball Use on Procedural Pain Caused by Subcutaneous Injection in Orthopedic Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Kırklareli University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Kırklareli 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>
        Randomization in the study will be done by the researchers with the Randomizer Research&#xD;
        program. The research will be carried out between 01.01.2023 and 01.10.2023 with the&#xD;
        participation of 134 patients who were hospitalized in the postoperative period at Trakya&#xD;
        University Health Research and Application Center Orthopedics and Traumatology Service and&#xD;
        participated voluntarily. In the study, in the G.Power 3.1.9.4 program, the effect size was&#xD;
        0.5, the confidence level was 95%, and the power was 80%, and the minimum sample size to be&#xD;
        reached was 134 patients (67 experiments- 67 controls), each group consisting of 67 people.&#xD;
        Before the study, all patients will be informed by the researchers, and written consent will&#xD;
        be obtained from the patients who volunteered to participate in the study. All patients will&#xD;
        be asked the questions in the Patient Information Form and the pretest Vizuel Analog Scala&#xD;
        (VAS) scores in the Patient follow-up form will be recorded before the subcutaneous (SC)&#xD;
        injection application. The patients in the experimental group will be given a stress ball&#xD;
        before the SC injection during the routine daytime treatment of the ward at 10:00. The&#xD;
        patient will be asked to squeeze the stress ball with his hand on the opposite extremity of&#xD;
        the upper extremity where SC injection was applied, counting to five, and then to relax his&#xD;
        hand. The level of pain in the area where SC was applied will be evaluated with VAS. For the&#xD;
        patients in the control group, 0.4 ml of LMWH will be administered by the nurse in the&#xD;
        routine daytime treatment of the service at 10:00, according to the doctor's request. During&#xD;
        the patient's drug administration and 2 minutes after the application. The level of pain in&#xD;
        the area where SC was applied will be evaluated with VAS.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The ramdomized research will be carried out between 01.01.2023 and 01.10.2023 with the&#xD;
        participation of 134 patients who were hospitalized in the postoperative period at Trakya&#xD;
        University Health Research and Application Center Orthopedics and Traumatology Service and&#xD;
        participated voluntarily. In the study, in the G.Power 3.1.9.4 program, the effect size was&#xD;
        0.5, the confidence level was 95%, and the power was 80%, and the minimum sample size to be&#xD;
        reached was 134 patients (67 experiments- 67 controls), each group consisting of 67 people.&#xD;
        The study included 18 patients who were hospitalized in the orthopedics and traumatology&#xD;
        clinic, were in the post-operative period, were not diabetic, conscious, cooperative and&#xD;
        oriented (without delirium, etc.), without a diagnosis of psychiatric disease, who could&#xD;
        localize the pain, did not undergo upper extremity surgery, and volunteered to participate in&#xD;
        the study. Age and older patients will be included. Before the study, all patients will be&#xD;
        informed by the researchers, and written consent will be obtained from the patients who&#xD;
        volunteered to participate in the study. All patients will be asked the questions in the&#xD;
        Patient Information Form and the pretest Vizuel Analog Scala (VAS) scores in the Patient&#xD;
        follow-up form will be recorded before the subcutaneous (SC) injection application. The&#xD;
        patients in the experimental group will be given a stress ball before the SC injection during&#xD;
        the routine daytime treatment of the ward at 10:00. The patient will be asked to squeeze the&#xD;
        stress ball with his hand on the opposite extremity of the upper extremity where SC injection&#xD;
        was applied, counting to five, and then to relax his hand. In the meantime, 0.4 ml of LMWH&#xD;
        will be administered by SC route according to the doctor's request. During the patient's drug&#xD;
        administration and 2 minutes after the application. The level of pain in the area where SC&#xD;
        was applied will be evaluated with VAS. For the patients in the control group, 0.4 ml of LMWH&#xD;
        will be administered by the nurse in the routine daytime treatment of the service at 10:00,&#xD;
        according to the doctor's request. During the patient's drug administration and 2 minutes&#xD;
        after the application. The level of pain in the area where SC was applied will be evaluated&#xD;
        with VAS. Unlike the control group, the patients in the experimental group will be asked to&#xD;
        tighten and loosen the stress ball during SC injection&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 1, 2023</start_date>
    <completion_date type="Anticipated">August 31, 2023</completion_date>
    <primary_completion_date type="Actual">May 15, 2023</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>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>pain management during subcutaneous injection</measure>
      <time_frame>9 months</time_frame>
      <description>The patient will be asked to squeeze the stress ball with his hand on the opposite extremity of the upper extremity where SC injection was applied, counting to five, and then to relax his hand. In the meantime, 0.4 ml of LMWH will be administered by SC route according to the doctor's request. During the patient's drug administration and 2 minutes after the application. The level of pain in the area where SC was applied will be evaluated with Vizuel Analog Scala (VAS). The VAS is a unidimensional scale frequently used to measure pain severity. The scale consists of a 10-cm demarcated line in which 0 cm represents no pain and 10 cm represents unbearable pain.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">134</enrollment>
    <condition>Misadventure During Injection / Vaccination</condition>
    <arm_group>
      <arm_group_label>Experimental group (stress ball)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The patients in the experimental group will be given a stress ball before the SC injection during the routine daytime treatment of the ward at 10:00. The patient will be asked to squeeze the stress ball with his hand on the opposite extremity of the upper extremity where SC injection was applied, counting to five, and then to relax his hand. In the meantime, 0.4 ml of LMWH will be administered by SC route according to the doctor's request. During the patient's drug administration and 2 minutes after the application. The level of pain in the area where SC was applied will be evaluated with VAS.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>For the patients in the control group, 0.4 ml of LMWH will be administered by the nurse in the routine daytime treatment of the service at 10:00, according to the doctor's request. During the patient's drug administration and 2 minutes after the application. The level of pain in the area where SC was applied will be evaluated with VAS.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>stress ball use during subcutaneous injection</intervention_name>
      <description>The effect of stress ball use on pain during subcutaneous injection</description>
      <arm_group_label>Experimental group (stress ball)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  patients;&#xD;
  &#xD;
            -  who were hospitalized in the orthopedics and traumatology clinic,&#xD;
  &#xD;
            -  who were in the post-operative period,&#xD;
  &#xD;
            -  who were not diabetic,&#xD;
  &#xD;
            -  who were conscious,&#xD;
  &#xD;
            -  who were cooperative and oriented (without delirium, etc.),&#xD;
  &#xD;
            -  who were not diagnosed with psychiatric disease,&#xD;
  &#xD;
            -  who could localize pain,&#xD;
  &#xD;
            -  who did not undergo upper extremity surgery, and&#xD;
  &#xD;
            -  who volunteered to participate in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who do not volunteer to participate in the study will not be included.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>FİGEN DIĞIN, DOCTORATE</last_name>
      <phone>5056461929</phone>
      <email>fgndgn2013@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Kırklareli University</name>
        <address>
          <city>Kırklareli</city>
          <zip>39100</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 27, 2023</study_first_submitted>
    <study_first_submitted_qc>August 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>September 2, 2023</last_update_submitted>
    <last_update_submitted_qc>September 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Kırklareli University</investigator_affiliation>
      <investigator_full_name>Figen Dıgın</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pain, Procedural</mesh_term>
    </condition_browse>
    <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/NCT06023485
  org study id: The Effect of Stress Ball Use
  secondary id: KLÜBAP-249
  secondary id: 2023-249
  secondary id: 2023-249
  nct id: NCT06023485
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Randomization in the study will be done by the researchers with the Randomizer Research
        program. The research will be carried out between 01.01.2023 and 01.10.2023 with the
        participation of 134 patients who were hospitalized in the postoperative period at Trakya
        University Health Research and Application Center Orthopedics and Traumatology Service and
        participated voluntarily. In the study, in the G.Power 3.1.9.4 program, the effect size was
        0.5, the confidence level was 95%, and the power was 80%, and the minimum sample size to be
        reached was 134 patients (67 experiments- 67 controls), each group consisting of 67 people.
        Before the study, all patients will be informed by the researchers, and written consent will
        be obtained from the patients who volunteered to participate in the study. All patients will
        be asked the questions in the Patient Information Form and the pretest Vizuel Analog Scala
        (VAS) scores in the Patient follow-up form will be recorded before the subcutaneous (SC)
        injection application. The patients in the experimental group will be given a stress ball
        before the SC injection during the routine daytime treatment of the ward at 10:00. The
        patient will be asked to squeeze the stress ball with his hand on the opposite extremity of
        the upper extremity where SC injection was applied, counting to five, and then to relax his
        hand. The level of pain in the area where SC was applied will be evaluated with VAS. For the
        patients in the control group, 0.4 ml of LMWH will be administered by the nurse in the
        routine daytime treatment of the service at 10:00, according to the doctor's request. During
        the patient's drug administration and 2 minutes after the application. The level of pain in
        the area where SC was applied will be evaluated with VAS.
  The ramdomized research will be carried out between 01.01.2023 and 01.10.2023 with the
        participation of 134 patients who were hospitalized in the postoperative period at Trakya
        University Health Research and Application Center Orthopedics and Traumatology Service and
        participated voluntarily. In the study, in the G.Power 3.1.9.4 program, the effect size was
        0.5, the confidence level was 95%, and the power was 80%, and the minimum sample size to be
        reached was 134 patients (67 experiments- 67 controls), each group consisting of 67 people.
        The study included 18 patients who were hospitalized in the orthopedics and traumatology
        clinic, were in the post-operative period, were not diabetic, conscious, cooperative and
        oriented (without delirium, etc.), without a diagnosis of psychiatric disease, who could
        localize the pain, did not undergo upper extremity surgery, and volunteered to participate in
        the study. Age and older patients will be included. Before the study, all patients will be
        informed by the researchers, and written consent will be obtained from the patients who
        volunteered to participate in the study. All patients will be asked the questions in the
        Patient Information Form and the pretest Vizuel Analog Scala (VAS) scores in the Patient
        follow-up form will be recorded before the subcutaneous (SC) injection application. The
        patients in the experimental group will be given a stress ball before the SC injection during
        the routine daytime treatment of the ward at 10:00. The patient will be asked to squeeze the
        stress ball with his hand on the opposite extremity of the upper extremity where SC injection
        was applied, counting to five, and then to relax his hand. In the meantime, 0.4 ml of LMWH
        will be administered by SC route according to the doctor's request. During the patient's drug
        administration and 2 minutes after the application. The level of pain in the area where SC
        was applied will be evaluated with VAS. For the patients in the control group, 0.4 ml of LMWH
        will be administered by the nurse in the routine daytime treatment of the service at 10:00,
        according to the doctor's request. During the patient's drug administration and 2 minutes
        after the application. The level of pain in the area where SC was applied will be evaluated
        with VAS. Unlike the control group, the patients in the experimental group will be asked to
        tighten and loosen the stress ball during SC injection
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Single (Participant)
  measure: pain management during subcutaneous injection
  time frame: 9 months
  description: The patient will be asked to squeeze the stress ball with his hand on the opposite extremity of the upper extremity where SC injection was applied, counting to five, and then to relax his hand. In the meantime, 0.4 ml of LMWH will be administered by SC route according to the doctor's request. During the patient's drug administration and 2 minutes after the application. The level of pain in the area where SC was applied will be evaluated with Vizuel Analog Scala (VAS). The VAS is a unidimensional scale frequently used to measure pain severity. The scale consists of a 10-cm demarcated line in which 0 cm represents no pain and 10 cm represents unbearable pain.
  arm group label: Experimental group (stress ball)
  arm group type: Experimental
  description: The patients in the experimental group will be given a stress ball before the SC injection during the routine daytime treatment of the ward at 10:00. The patient will be asked to squeeze the stress ball with his hand on the opposite extremity of the upper extremity where SC injection was applied, counting to five, and then to relax his hand. In the meantime, 0.4 ml of LMWH will be administered by SC route according to the doctor's request. During the patient's drug administration and 2 minutes after the application. The level of pain in the area where SC was applied will be evaluated with VAS.
  arm group label: Control group
  arm group type: No Intervention
  description: For the patients in the control group, 0.4 ml of LMWH will be administered by the nurse in the routine daytime treatment of the service at 10:00, according to the doctor's request. During the patient's drug administration and 2 minutes after the application. The level of pain in the area where SC was applied will be evaluated with VAS.
  intervention type: Other
  intervention name: stress ball use during subcutaneous injection
  description: The effect of stress ball use on pain during subcutaneous injection
  arm group label: Experimental group (stress ball)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: FİGEN DIĞIN, DOCTORATE
  phone: 5056461929
  email: fgndgn2013@gmail.com
  facility: 
  status: Recruiting
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Kırklareli University
  investigator full name: Figen Dıgın
  investigator title: Assistant Professor
  mesh term: Pain, Procedural
  sharing ipd: No