<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20220929056057N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-01-01</date_registration>
      <primary_sponsor>College of Nursing, University of Baghdad</primary_sponsor>
      <public_title>Reducing Intramuscular Injection-Related Pain</public_title>
      <acronym></acronym>
      <scientific_title>Manual Pressure versus Shotblocker in Reducing Intramuscular Injection-Related Pain: A Comparative Randomized Controlled Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-12-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>128</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66136</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: In order to maintain a transparent &amp; scientific-based randomization process, simple randomization will be used in assigning participants to 2 intervention &amp; control groups, assuming that each participant has an equal chance of being assigned to any group. The simple randomization procedure would involve throwing a dice (eg, below &amp; equal to 3 = control, over 3 =treatment). No allocation concealment will be carried out.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Pain management related intramuscular injection..</hc_freetext>
      <i_freetext>Intervention group: Intervention group: In the beginning, the patient’s consent is taken, and then a lottery is made to choose the intervention, either Shotblocker or Manuel Presser, then a questionnaire is given to him, and then the intervention is performed by one of the methods, then the pain intensity is measured using visual analogue scale (VAS)score.                      Control group: the intramuscular injection is given using the traditional method in the posterior gluteal region, and then the pain intensity is measured using visual analogue scale (VAS)score..</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
The researcher is acknowledging the scientific community to have verifiable findings of the study. sharing plan includes making all the related data available through publishing the study report in peer-reviewed reputable journals.

When:
God willing, once finishing the process of data collection, analysis and successfully publishing the manuscript, all the related files will become available for 6 months after publications

To whom:
All the related files will be shared with any scientific interested parties.

Conditions:
It may be used after seeking the author's permission and acknowledging his contribution.

Where to obtain:
The author's professional e-mail that will be available with the published manuscript can be used to contact the author. e-Mail: safaa.ezzat2102m@conursing.uobaghdad.edu.iq

How to obtain:
N/A

Comments:
Profound appreciations are due to the IRCT members for their genuine efforts in helping researchers fulfilling their academic endeavors.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Safaa Ezzat Hassan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Military district</address>
        <city>Al-Zubiadiy</city>
        <country1>Iraq</country1>
        <zip>10001</zip>
        <telephone>+964 780 615 9401</telephone>
        <email>safaa.ezzat2102m@conursing.uobaghdad.edu.iq</email>
        <affiliation>University of Baghdad, College of Nursing</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Safaa Ezzat Hassan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Military district</address>
        <city>Al-Zubiadiy</city>
        <country1>Iraq</country1>
        <zip>10001</zip>
        <telephone>+964 780 615 9401</telephone>
        <email>safaa.ezzat2102m@conursing.uobaghdad.edu.iq</email>
        <affiliation>University of Baghdad, College of Nursing</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iraq</country2>
    </countries>
    <criteria>
      <inclusion_criteria>18 to 80 years of age.
Patients did not use analgesics or sedatives with central or peripheral effects.
No difficulty in communication, including hearing, visual, speech, and language problems.
Having two healthy muscles of the same size.
No sensory problems in the ventrogluteal muscles.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Male</gender>
      <exclusion_criteria>The presence of scars, redness, bruising, tenderness, and stiffness at the injection site.
Patients use analgesics or sedatives with central or peripheral effects.
History of injections in the past two weeks.
Presence of neuropathy.
Drug abuse.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group: In the beginning, the patient’s consent is taken, and then a lottery is made to choose the intervention, either Shotblocker or Manuel Presser, then a questionnaire is given to him, and then the intervention is performed by one of the methods, then the pain intensity is measured using visual analogue scale (VAS)score.                      Control group: the intramuscular injection is given using the traditional method in the posterior gluteal region, and then the pain intensity is measured using visual analogue scale (VAS)score.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Intramuscular related pain (reducing). Timepoint: The patient's response after giving the intramuscular injection directly to measure the intensity of pain. Method of measurement: Pain scale(VAS)score to measure the intensity of pain as a result of intramuscular injection.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>The author of the trial is the funding source</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-12-04</approval_date>
        <contact_name>Research Ethical Approval Committee, at the College of Nursing</contact_name>
        <contact_address>Military district Al-zubydia Wasit Iraq</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
