<?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>IRCT20240111060680N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-02-13</date_registration>
      <primary_sponsor>Kerbala University</primary_sponsor>
      <public_title>Effect of  Acupressure Technique and Diaphragmatic Breathing Exercise on Nausea and Vomiting in patient with Cholecystectomy :A Clinical Trial</public_title>
      <acronym></acronym>
      <scientific_title>Effect of  Acupressure Technique and Diaphragmatic Breathing Exercise on  Nausea and Vomiting in Cholecystectomy Patient: A comparative study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-01-31</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/75239</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: Quasi experimental design purposive  sample  comparative study with a minimum sample size of 30 for each group will be used. The total sample size would be 90  subjects.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Cholecystectomy patient.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: group1   perform the acupressure technique on pc6 with wrist band were used for this technique which are elastic wrist bands with plastic button 1cm in diameter stud ,The Stud  of the wrist band pressing upon PC6acupoint it is located on the anterior surface of the forearm ,about three finger 'width up from the wrist crease ,between the tendon of the palmaris longus and flexior carpi radialis The patient wearing wrist bands at pc6  bilaterally starting at 0   hour postoperative      and Removed  for 6 hours .Group 2  Diaphragmatic Breathing Exercise starting through inhale the nose slowly  to take as much as possible amount of air ,while the mouth was closed and keep it on for few second paying close attention to the abdomen-hand movement with each breath while keeping the hand on the chest steady and then exhale slowly through the mouth for a few seconds in a circle shape, The patient in this group were instructed to perform diaphragmatic breathing exercise for 2-3  min every two hour  for 6 hours  , in all groups were evaluated prior to the intervention (post-test assessment) after six hours by using the Rhodes index and visual analog scale for assess nausea and vomiting  level. Intervention 2: Control group received no intervention ;instead they received pretest   and post test assessment after 6 hours ,as did the other groups ,and  they will be compared to the other groups in the study. Then patients in all groups were evaluated prior to the intervention (post-test assessment) after 6 hours by using the  Rhodes index and Visual Analog Scale .</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 data will be the result of Cholecystectomy Patient with Nausea and Vomiting  Level in Both the Control and Intervention Groups .

When:
God Willing,Once the Article is Published, The Data will be Available after 6 Months of  Publication. If the Article will be Published in a  Subscribed Journal, The Data Will be Available after One Year because of the Policy of The Subscribed Journals.

To whom:
With Academic  Nurses and any Researcher who is Interested in the Data.

Conditions:
The Data Could be Used after Getting permission Via Email. Also, Users need to Acknowledge The Owner.

Where to obtain:
Users can Ask for the Data and Permission via email. is the Corresponding Author. He will contact whoever he requests the information from. His email is bushra.a@s.uokerbala.edu.iq Bushra Abd Alli works at the University of Kerbala/College of Nursing. The address is Al- Baladia  district, Kerbala, Iraq.
What processes are involved for a request to access data/document

How to obtain:
Users Can ask for The Data and Permission via email. Bushra Abd Ali Jasem is The Corresponding Author. He will Contact whoever he Requests the Information from. His email is bushra.a@s.uokerbala.edu.iq

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Bushra Abd Ali Jasem</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Al-Baladia Distract</address>
        <city>karbala</city>
        <country1>Iraq</country1>
        <zip>10053</zip>
        <telephone>+964 771 434 0379</telephone>
        <email>bushra.a@s.uokerbala.edu.iq</email>
        <affiliation>University of Kerbala</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Bushra Abd Ali Jaesm</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Al-Baladia Distract</address>
        <city>Karbala</city>
        <country1>Iraq</country1>
        <zip>10053</zip>
        <telephone>+964 771 434 0379</telephone>
        <email>bushra.a@s.uokerbala.edu.iq</email>
        <affiliation>University of Kerbala</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iraq</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patient Those who are Surgical Diagnosed with Cholecystectomy
Patient between Age 18-and above , Able to perform intervention.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patient who have Discontinuing to Intervention-
Patient who had  on Mechanical Ventilation and/or in Intensive Care for More than 48 hours
Patient who have Amputation in Upper Extremity</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R11</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Nausea and Vomiting</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: group1   perform the acupressure technique on pc6 with wrist band were used for this technique which are elastic wrist bands with plastic button 1cm in diameter stud ,The Stud  of the wrist band pressing upon PC6acupoint it is located on the anterior surface of the forearm ,about three finger 'width up from the wrist crease ,between the tendon of the palmaris longus and flexior carpi radialis The patient wearing wrist bands at pc6  bilaterally starting at 0   hour postoperative      and Removed  for 6 hours .Group 2  Diaphragmatic Breathing Exercise starting through inhale the nose slowly  to take as much as possible amount of air ,while the mouth was closed and keep it on for few second paying close attention to the abdomen-hand movement with each breath while keeping the hand on the chest steady and then exhale slowly through the mouth for a few seconds in a circle shape, The patient in this group were instructed to perform diaphragmatic breathing exercise for 2-3  min every two hour  for 6 hours  , in all groups were evaluated prior to the intervention (post-test assessment) after six hours by using the Rhodes index and visual analog scale for assess nausea and vomiting  level.</i_keyword>
      <i_keyword>Control group received no intervention ;instead they received pretest   and post test assessment after 6 hours ,as did the other groups ,and  they will be compared to the other groups in the study. Then patients in all groups were evaluated prior to the intervention (post-test assessment) after 6 hours by using the  Rhodes index and Visual Analog Scale .</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The primary outcome variable is the level of nausea and vomiting post operative in patient cholecystectomy that can be changed based on Acupressure Technique and diaphragmatic breathing exercises. Timepoint: Before intervention and 6 hours after intervention. Method of measurement: The Rhodes index  and visual analog scale will be used to assess the level of nausea vomiting.</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>2023-09-26</approval_date>
        <contact_name>Ethics committee in College of Nursing at University of Kerbela</contact_name>
        <contact_address>Al-Baladia Distract Karbala karbala Iraq</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
