<?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>IRCT20220608055105N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-11-03</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The effects of acupressure on the volume of urine and the intensity of micturition pain caused by prostate enlargement</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effects of acupressure on residual urine volume and dysuria in patients with benign prostatic hypertrophy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-06-15</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64065</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible samples are first available and then randomly allocated in two intervention and control groups.  In order to randomize, we use an opaque envelope that contains numbers equal to the number of the sample (from 1 to 20), in such a way that every patient who comes, we remove one number from the envelope. If the number is odd, the patient will be assigned to The intervention group is entered, and if it is even, it is entered into the control group, this process continues until reaching the desired sample size, Blinding description: The only person who knows about the patient's treatment will be an acupressure specialist, and the researcher and sonographer will not know about the patient's treatment group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Benign prostatic hypertrophy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patients with benign prostatic hypertrophy who complain of urinary retention will be treated with acupressure on the affected points. The four main points in acupressure (Pang guanshu, Guan yuan, Shen men, San yinjiao) will be placed with the fingers for one minute and three kilograms of pressure. The length of treatment is 6 sessions in 2 weeks. The first point of acupressure group is BL 28 or Pang guanshu. This point is located at a distance of 1.5 as lateral to the posterior midline of the body at the level of the second hole of the sacrum or sacrum. The second point of acupressure group is CV4 or Guan yuan. This point is located on the middle line of the front of the body at a distance of 3 cm below the navel. The third point of acupressure group is HT7 or Shen men. This point is located on the lowest inner crease of the wrist, immediately after the tendon of the flexor carpi ulnaris muscle and on the radial side of the tendon. The fourth point of acupressure group is SP6 or San yinjiao. This point is located at a distance of 3, because it is above the most prominent part of the inner ankle of the foot and immediately behind the tibia bone. Intervention 2: Control group: patients with benign prostatic hypertrophy who complain of urinary retention and will be treated with sham or ineffective acupressure (Cheng Jian, Fei shu, Shao hai, Gong sun). Four ineffective points (sham) in acupressure will be placed with a finger for one minute each and a pressure of three kilograms. The length of the treatment is 6 sessions in 2 weeks. The first point of the acupressure group is Sham CV 24 or Cheng Jian. This point is located in the midline of the front of the body under the lower lip and in the mentolabial groove. The second point of the acupressure group is Sham BL 13 or Fei shu. This point is located on the back of the body and in alignment with the lower edge of the third thoracic vertebra and at a distance of 1.5 cm lateral to the midline of the back of the body. The third point of the Sham acupressure group is HT3 or Shao hai. This point is located in the inner part of the elbow bend between the inner end of the elbow crease and the inner epicondyle of the humerus. The fourth point of the Sham acupressure group is SP4 or Gong sun. This point is on the surface The inside of the foot is located on the border of the white and red skin of the sole and exactly in the middle of the foot arch.</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:
Research units participating in this study
Data include demographic characteristics, intervening variables, main variables (independent and dependent)

When:
From the beginning of July 2022 to December 2022

To whom:
Researcher, research assistant and statistics consultant

Conditions:
The data is organized as an article and published in reputable journals

Where to obtain:
Mr. Hamid Chamanzari/ Faculty of Nursing and Midwifery Mashhad/ ChamanzariH@mums.ac.ir/ 05138591511

How to obtain:
By obtaining permission from Mashhad University of Medical Sciences and then sending the application email along with the permission to the study researcher's email

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hamid Chamanzari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Doctora Crossroads - Ibn Sina St. - School of Nursing and Midwifery</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>AljenahiA991@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hamid Chamanzari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Doctora Crossroads - Ibn Sina St. - School of Nursing and Midwifery</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>AljenahiA991@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosis of Benign prostate hypertrophy by a specialist
Confirmation of the residual volume of the disease after evacuation of more than 100 cc with ultrasound
No coagulation disorders</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>no limit</agemax>
      <gender>Male</gender>
      <exclusion_criteria>The patient has undergone prostate surgery
The patient is not conscious or it is not possible to put pressure on the pressure points  by him</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N40</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Enlarged prostate</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Patients with benign prostatic hypertrophy who complain of urinary retention will be treated with acupressure on the affected points. The four main points in acupressure (Pang guanshu, Guan yuan, Shen men, San yinjiao) will be placed with the fingers for one minute and three kilograms of pressure. The length of treatment is 6 sessions in 2 weeks. The first point of acupressure group is BL 28 or Pang guanshu. This point is located at a distance of 1.5 as lateral to the posterior midline of the body at the level of the second hole of the sacrum or sacrum. The second point of acupressure group is CV4 or Guan yuan. This point is located on the middle line of the front of the body at a distance of 3 cm below the navel. The third point of acupressure group is HT7 or Shen men. This point is located on the lowest inner crease of the wrist, immediately after the tendon of the flexor carpi ulnaris muscle and on the radial side of the tendon. The fourth point of acupressure group is SP6 or San yinjiao. This point is located at a distance of 3, because it is above the most prominent part of the inner ankle of the foot and immediately behind the tibia bone.</i_keyword>
      <i_keyword>Control group: patients with benign prostatic hypertrophy who complain of urinary retention and will be treated with sham or ineffective acupressure (Cheng Jian, Fei shu, Shao hai, Gong sun). Four ineffective points (sham) in acupressure will be placed with a finger for one minute each and a pressure of three kilograms. The length of the treatment is 6 sessions in 2 weeks. The first point of the acupressure group is Sham CV 24 or Cheng Jian. This point is located in the midline of the front of the body under the lower lip and in the mentolabial groove. The second point of the acupressure group is Sham BL 13 or Fei shu. This point is located on the back of the body and in alignment with the lower edge of the third thoracic vertebra and at a distance of 1.5 cm lateral to the midline of the back of the body. The third point of the Sham acupressure group is HT3 or Shao hai. This point is located in the inner part of the elbow bend between the inner end of the elbow crease and the inner epicondyle of the humerus. The fourth point of the Sham acupressure group is SP4 or Gong sun. This point is on the surface The inside of the foot is located on the border of the white and red skin of the sole and exactly in the middle of the foot arch.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>IPSS Symptom Score. Timepoint: 6 sessions in 2 weeks. Method of measurement: Demographic information: Checklist containing patients' demographic information, IPSS symptom score (international prostate symptom score), volume of patient's voided urine: using a graduated container, starting time of voiding: by asking the patient, dysuria: by asking the patient, residual volume Urine before and 48 hours after the end of the course: with sonography.</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>Research assistant of Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-07-19</approval_date>
        <contact_name>Ethics Committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Doctor Crossroads - Ibn Sina St.  School of Nursing and Midwifery - Postal Code: 9137913199 Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
