<?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>IRCT20231101059928N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-01-06</date_registration>
      <primary_sponsor>College of Nursing, University of Baghdad</primary_sponsor>
      <public_title>Effect of Cold Application on Pain Intensity for Patients  Undergoing Sheath Removal</public_title>
      <acronym>Effect of Cryotherapy on Pain Intensity (ECPI)</acronym>
      <scientific_title>Effect of Cryotherapy on Pain Intensity for Patients  Undergoing Sheath Removal after Percutaneous Coronary  Intervention: A Randomized Controlled Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-11-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>410</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/73556</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In order to maintain a transparent and scientific-based randomization process by using a probability-based (random sample) technique, participants (patients who underwent percutaneous coronary intervention) were divided into two groups: the intervention group and the control group. offering the sample two cards of various colors in a box and using a random allocation mechanism to choose one card to represent the research group. The intervention group is represented by the blue card, while the control group is represented by the yellow card.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Patients who underwent percutaneous coronary intervention to treat coronary heart diseases..</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The questionnaire (which includes demographic and clinical data) will be given to the respondents as the first step in the intervention phase. After putting the patient in a supine position and removing the femoral sheath, a tiny dressing is applied over the insertion site, cold therapy is administered by applying pressure for 20 minutes, and the Visual Analogue Scale (VAS) is used to measure the pain intensity for the patients. Intervention 2: Control group: The control group following participant completion of the questionnaire. Starting the sheath removal with standard procedures and without further intervention. Assess the level of pain intensity after 20 minutes by asking the patient to mark a point on the VAS (0–100 mm) line to indicate their level of pain and discomfort.</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 acknowledges that the scientific community has verified the study's results. As part of the sharing strategy, all relevant data will be made public by publishing the study report in respected, peer-reviewed publications.

When:
God willing, when the data collecting, analysis, and paper publication procedure is complete, all associated materials will be accessible for six months following publication.

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:
To get in touch with the author, use the business email address that will be provided along with the published work.  jameel.ali2202m@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>Jameel Ali Al-Zuhary</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Al-Kifil, Al-Zuhary neighborhood, House No 3, Street No 62</address>
        <city>Babylon</city>
        <country1>Iraq</country1>
        <zip>14149</zip>
        <telephone>+964 781 442 6463</telephone>
        <email>jameel.ali2202m@conursing.uobaghdad.edu.iq</email>
        <affiliation>College of Nursing, University of Baghdad</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Jameel Ali Al-Zuhary</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Al-Kifil, Al-Zuhary neighborhood, House No 3, Street No 62</address>
        <city>Babylon</city>
        <country1>Iraq</country1>
        <zip>14149</zip>
        <telephone>+964 781 442 6463</telephone>
        <email>jameel.ali2202m@conursing.uobaghdad.edu.iq</email>
        <affiliation>College of Nursing, University of Baghdad</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iraq</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Male and female adults (18 years of age and older) who volunteered to participate in the study and signed a written consent form were eligible to be included.
Patients who underwent a single-catheter coronary angioplasty through the femoral artery in the groin area.
The participants had to read and write.
They had not taken analgesics in the last few hours and were free from any hematoma or infection on the skin surrounding the sheath site.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>If the subjects declined to participate, they were eliminated.
If patients suffer from severe visual impairment, a changed mental state, skin conditions linked to cold sensitivity (such as Raynaud's disease), sensory-motor deficiency, diabetes, neuropathy, and scar tissue from burns, wounds, or other injuries surrounding the sheath site.
Patients have a two-sheath area in the femur.
Individuals undergoing peripheral catheterization.
Patients have a hematoma and bleeding in the surrounding area of the femur artery before sheath removal.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I20-I25</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Ischemic heart diseases</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The questionnaire (which includes demographic and clinical data) will be given to the respondents as the first step in the intervention phase. After putting the patient in a supine position and removing the femoral sheath, a tiny dressing is applied over the insertion site, cold therapy is administered by applying pressure for 20 minutes, and the Visual Analogue Scale (VAS) is used to measure the pain intensity for the patients.</i_keyword>
      <i_keyword>Control group: The control group following participant completion of the questionnaire. Starting the sheath removal with standard procedures and without further intervention. Assess the level of pain intensity after 20 minutes by asking the patient to mark a point on the VAS (0–100 mm) line to indicate their level of pain and discomfort.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Relieve the pain intensity that occurs after arterial sheath removal. Timepoint: When arterial sheath removal is immediately applied, an intervention for 20 minutes is applied, and the pain intensity is measured by the Visual Analogue Scale (VAS) after that. Method of measurement: Questionnaire and Visual Analogue Scale (VAS).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Relieve the pain intensity that occurs after arterial sheath removal. Timepoint: When arterial sheath removal is immediately applied, an intervention for 20 minutes is applied, and the pain intensity is measured by the Visual Analogue Scale (VAS) after that. Method of measurement: Questionnaire and Visual Analogue Scale (VAS).</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>2023-11-30</approval_date>
        <contact_name>Research Ethical Approval Committee, at the College of Nursing.</contact_name>
        <contact_address>Bab AL-Muadum Baghdad Baghdad Iraq</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
