<?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>IRCT20190117042393N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-02-03</date_registration>
      <primary_sponsor>Bojnourd University of Medical Sciences</primary_sponsor>
      <public_title>acupressure on the severity of functional constipation in elderly women</public_title>
      <acronym></acronym>
      <scientific_title>The effect of acupressure on the severity of functional constipation in elderly women   referring to the medical clinic  Hospital of Social Security in Bojnourd 1397</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-01-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/36930</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Basic scienece, Randomization description: 70 people aged 50-70 years attending a social welfare clinic who suffer from constipation or other complaints, but at the same time suffering from constipation, are selected based on objective sampling and each person has a proprietary code given by A statistic consultant is provided in blocks 2 and unaware of which code belongs to which group is placed in the envelope (with random allocation based on the referral of patients) and the subjects are randomly assigned to two groups of control and intervention Get it The intervention group carries out a routine treatment approach plus acupressure at the designated points for 4 weeks, and the control group also has a common therapeutic approach. And questionnaires are completed before and after the intervention by a researcher who is unaware of the intervention and control group. Constipation is the main variable in this studyp also performs the usual treatment, Blinding description: 1-The researcher's assistance completes the questionnaires before intervention and 4 weeks after the intervention and unaware of the control and intervention group.
2-The data analyzer also analyzes the data without knowing the control group and interfering them with the code given to them.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Constipation.</hc_freetext>
      <i_freetext>Intervention 1: The intervention group receives the usual therapeutic approach and 4 weeks of acupressure twice a day by the individual. Intervention 2: Control group:  The control group continues their usual treatment and does not receive an intervention.</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>Zohreh Nazari Kushaki</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Central building of North Khorasan University of Medical Sciences, Government boulevard, Bojnourd</address>
        <city>Bojnord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>74877-94149</zip>
        <telephone>+98 58 3229 7156</telephone>
        <email>z.nazari1126@gmail.com</email>
        <affiliation>Bojnourd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahboubeh Tabatabaei chehr</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Central building of North Khorasan University of Medical Sciences, Government boulevard, Bojnourd</address>
        <city>Bojnord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>74877-94149</zip>
        <telephone>+98 58 3229 7097</telephone>
        <email>chehr192@gmail.com</email>
        <affiliation>Bojnourd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1-Patients in the age range of 50-70 years
2- Mentally minded and able to answer questions.
3 - Have a chance
4 - Constipation according to Rome III.
5. Lack of history of diseases, spinal cord injuries, inflammatory digestive diseases, gastrointestinal obstructive diseases, gastrointestinal bleeding, lupus erythematosus, Parkinson's disease, hypothyroidism, hyperparathyroidism, advanced leg legs, thrombophlebitis, bone marrow, non-use of anti-Parkinson drugs, Psychiatric disorders according to medical records, acute stress disorder, pituitary gland palsy, sympathomimetics, lack of history of anti diarrhea drugs, psychotropic drugs and no history of injury in the abdomen and legs and arms during the last two years and lack of medication Constipation causes iron, if necessary, tests Laboratory Rmal like TSH, lack of blood in the stool, normal liver enzyme alkaline phosphatase, and normal WBC, and pelvic floor problems, no history of serious illness.
6. Non-drug and alcohol addiction
7. Absence in the nursing home (due to the lack of control and intervention and the easy access to samples)</inclusion_criteria>
      <agemin>50 years</agemin>
      <agemax>70 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>1- Emergency and side effects during the intervention
2- Diet change to relieve constipation during the intervention period.
3. Failure to perform acupressure program more than 3 times a week.
4. Critical psychological, psychological, mourning, divorce, travel, patient death.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>k90-k93</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other diseases of the digestive system</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention group receives the usual therapeutic approach and 4 weeks of acupressure twice a day by the individual.</i_keyword>
      <i_keyword>Control group:  The control group continues their usual treatment and does not receive an intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Score the severity of the constipation. Timepoint: At the beginning of the study (before the start of the study) and 4 weeks after the start of the intervention. Method of measurement: Million and Williams constipation severity questionnaire.</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>Bojnourd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-09-26</approval_date>
        <contact_name>Ethics Committee of North Khorasan University of Medical Sciences</contact_name>
        <contact_address>Central building of North Khorasan University of Medical Sciences, Government boulevard, Bojnourd Bojnord North Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
