<?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>IRCT20230310057672N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-03-30</date_registration>
      <primary_sponsor>College of Nursing, University of Baghdad</primary_sponsor>
      <public_title>Vibration and Exercise Maneuvers to Minimize Patients’ shoulder pain post lap chole: A Randomized clinical trial</public_title>
      <acronym>A Randomized clinical trial (ARCT)</acronym>
      <scientific_title>Effect of Vibration and Exercise on Shoulder Pain for Patients after Laparoscopic Cholecystectomy : A Randomized Clinical Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-04-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>92</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69121</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 &amp; scientific-based randomization process, simple randomization will be used in assigning participants (patients with shoulder pain), to 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 the dice (eg, below &amp; equal to 3  =  control, over 3  =  intervention). No allocation concealment will be carried out.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Pain in Shoulder after laparoscopic cholecystectomy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The starting point for the intervention phase will be to ask the patient after two hours from laparoscopic cholecystectomy  'Do you have shoulder pain' questionnaire. If say yes give a score of pain from 0-10 as a numerical pain scale, this mandatory step will help to identify the severity of patients' pain before and after applying the vibration by a reliable device and stander exercise for the shoulder (Williams &amp; Wilkins, 2011). We will evaluate the effectiveness of the clinical intervention on the same first day after laparoscopic cholecystectomy to the third day. Intervention 2: Control group: In order to be matched with patients in the intervention group, control group subjects with shoulder pain after laparoscopic cholecystectomy will be determined. No intervention will be given to them during the study.</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 successful publishing of the manuscript, all the related files will become available for Five months after the 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: alaaj@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>Alaa Jawad Kadhim</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Al Rasafa, New Baghdad, House No 19/20, Street No 77, Section No 729</address>
        <city>Baghdad</city>
        <country1>Iraq</country1>
        <zip>10001</zip>
        <telephone>+964 1 521 1494</telephone>
        <email>alaaj@conursing.uobaghdad.edu.iq</email>
        <affiliation>University of Baghdad, College of Nursing</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Alaa Jawad Kadhim</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Al Rasafa, New Baghdad, House No 19/20, Street No 77, Section No 729</address>
        <city>Baghdad</city>
        <country1>Iraq</country1>
        <zip>10001</zip>
        <telephone>+964 1 521 1494</telephone>
        <email>alaaj@conursing.uobaghdad.edu.iq</email>
        <affiliation>College of Nursing, University of Baghdad</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iraq</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Consent &amp; compliance with all aspects of the clinical trial, methods, providing data during follow-up phase
Contact male &amp; female patients, who are 18-70 years old at the time of the data collection phase</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Involvement with any other ongoing studies.
Medically diagnosed with psycho-mental diseases.
Patients who suffer from shoulder pain before undergoing laparoscopic cholecystectomy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M25.519</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pain in unspecified shoulder</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 starting point for the intervention phase will be to ask the patient after two hours from laparoscopic cholecystectomy  'Do you have shoulder pain' questionnaire. If say yes give a score of pain from 0-10 as a numerical pain scale, this mandatory step will help to identify the severity of patients' pain before and after applying the vibration by a reliable device and stander exercise for the shoulder (Williams &amp; Wilkins, 2011). We will evaluate the effectiveness of the clinical intervention on the same first day after laparoscopic cholecystectomy to the third day.</i_keyword>
      <i_keyword>Control group: In order to be matched with patients in the intervention group, control group subjects with shoulder pain after laparoscopic cholecystectomy will be determined. No intervention will be given to them during the study.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Shoulder Pain after Laparoscopic Cholecystectomy (Relief or Minimize). Timepoint: The clinical intervention of the experiment is carried out two hours after the laparoscopic gallbladder removal operation for patients, and the results of the intervention appear to reduce the intensity of shoulder pain from the first postoperative day to the third day. Method of measurement: Measurement method before and after clinical intervention using a numerical pain scale to measure shoulder pain.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Minimize Patients’ shoulder pain post lap chole. Timepoint: The secondary outcome is measured following the application of intervention and after 2-4 hours on the same day of intervention. Method of measurement: Interview Method: The patient has shoulder pain after laparoscopic cholecystectomy.</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>2022-12-07</approval_date>
        <contact_name>Research Ethical Approval Committee, at the College of Nursing</contact_name>
        <contact_address>Bab AL-Muadum Baghdad  Iraq</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
