<?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>IRCT20190524043687N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-05-03</date_registration>
      <primary_sponsor>Hamedan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of acupressure on the intensity of nausea, pain and physiological parameters of patients treated with extracorporeal lithotripsy</public_title>
      <acronym></acronym>
      <scientific_title>The effect of acupressure on the intensity of nausea, pain and physiological parameters of patients treated with extracorporeal lithotripsy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69117</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization method: Block randomization method with unequal blocks. will be used - Randomization unit: individual - How to build a random sequence: An equal number of each group will be placed in each block. In this way, first, the list of all permutations related to the size of the desired block is determined and then will be randomly as many as the number of samples from the permutation. The method used to generate the random allocation sequence is using a computer. The method of concealing the allocation is to use sealed envelopes, Blinding description: The blind groups in this study include patients and an assistant research collector; in such a way that none of the patients and the data collector will be aware of the allocation of patients to the two intervention and control groups.</study_design>
      <phase>3</phase>
      <hc_freetext>Urinary stones.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patients in the intervention group will receive the intervention before the extra-organ stone crushing in the same place in a room with minimal environmental stimuli (such as sound, temperature, light, etc.) while respecting privacy. For this purpose, the researcher first takes out his watch and ring and washes and warms his hands, then stretches the paravanes around the patient's bed and the patient lies on the opposite side that is in pain so that the painful side of the patient faces the side. be placed above the patient's knees are slightly bent into the abdomen. Acupressure intervention in the present study is performed at the acupuncture point of Qiu. This point was first identified by Yunqiao Qiu, a urology specialist at a hospital affiliated with Guangzhou Medical University in China, for treating acute kidney colic pain. This anatomical point is located about the width of one finger (the size of the body is equivalent to 1.3 inches) below and one thumb's width inside the intersection of the twelfth rib and the column of vertebrae (Lumbo-costal point). After observing the location choosing the exact location and marking it with his thumb, the researcher presses a force in the direction of 45 degrees to the spine for 3 minutes. Thumb strength will be done gradually and with a regular rhythm until the patient feels warmth in the area. The massage intervention will be repeated once exactly before the commencement of lithotripsy. The results examined in this study are measured before massage and at 1, 10, 20, 30, 40, and 50 minutes. Intervention 2: Control group: In the control group, according to the protocol of the acupressure intervention group, they will receive massage intervention at the neutral point and around the main point.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ali Safdari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517838736</zip>
        <telephone>+98 81 3838 0447</telephone>
        <email>asafdari.nu@gmail.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyed Reza Borzou</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517838698</zip>
        <telephone>+98 81 3838 0447</telephone>
        <email>Borzou@umsha.ac.ir</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Eligible for with extracorporeal lithotripsy according to the doctor's diagnosis
Signing an informed consent form
The age range of 18 to 65
Perform extracorporeal lithotripsy for the first time</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Have previous experience or knowledge of the effects of acupressure
Lack of full consciousness
Having mental, visual and auditory disorders and neuropathy
Drug addiction
Existence of an obstacle at the site of pressure (wounds, skin diseases, etc)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N20.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Calculus of kidney</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: Patients in the intervention group will receive the intervention before the extra-organ stone crushing in the same place in a room with minimal environmental stimuli (such as sound, temperature, light, etc.) while respecting privacy. For this purpose, the researcher first takes out his watch and ring and washes and warms his hands, then stretches the paravanes around the patient's bed and the patient lies on the opposite side that is in pain so that the painful side of the patient faces the side. be placed above the patient's knees are slightly bent into the abdomen. Acupressure intervention in the present study is performed at the acupuncture point of Qiu. This point was first identified by Yunqiao Qiu, a urology specialist at a hospital affiliated with Guangzhou Medical University in China, for treating acute kidney colic pain. This anatomical point is located about the width of one finger (the size of the body is equivalent to 1.3 inches) below and one thumb's width inside the intersection of the twelfth rib and the column of vertebrae (Lumbo-costal point). After observing the location choosing the exact location and marking it with his thumb, the researcher presses a force in the direction of 45 degrees to the spine for 3 minutes. Thumb strength will be done gradually and with a regular rhythm until the patient feels warmth in the area. The massage intervention will be repeated once exactly before the commencement of lithotripsy. The results examined in this study are measured before massage and at 1, 10, 20, 30, 40, and 50 minutes.</i_keyword>
      <i_keyword>Control group: In the control group, according to the protocol of the acupressure intervention group, they will receive massage intervention at the neutral point and around the main point.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Intensity of pain. Timepoint: Before intervention, 1, 10, 20, 30, 40 and 50 minutes after the intervention. Method of measurement: Numeric pain rating scale.</prim_outcome>
      <prim_outcome>Intensity of nausea. Timepoint: The intensity of nausea will be evaluated before and after extracorporeal shock wave lithotripsy. Method of measurement: Self-report scale.</prim_outcome>
      <prim_outcome>Heart rate. Timepoint: Before intervention, 1, 10, 20, 30, 40 and 50 minutes after the intervention. Method of measurement: Number of beats per minute - pulse oximeter.</prim_outcome>
      <prim_outcome>Blood pressure. Timepoint: Before intervention, 1, 10, 20, 30, 40 and 50 minutes after the intervention. Method of measurement: By sphygmomanometer.</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>Hamedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-04-29</approval_date>
        <contact_name>Research Ethical Committee of Hamadan University of Medical Sciences</contact_name>
        <contact_address>Hamadan University of Medical Science, Shahid Fahmide Boulevard, Hamadan, Iran Hamadan Hamadan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
