<?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>IRCT2016070428788N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-08-31</date_registration>
      <primary_sponsor>Hamedan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of self- care education on blood pressure control</public_title>
      <acronym></acronym>
      <scientific_title>The effect of self-care education on  control hypertension and pre- hypertension</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-09-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/23259</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Other.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Hypertensive.</hc_freetext>
      <i_freetext>Intervention 1: The present quasi-experimental study starts with obtaining required permissions from the School of Nursing and Midwifery in Hamedan University of Medical Sciences. The researcher will attend Hamedan University of Medical Sciences, explain the research objectives, and call for participation to measure and record blood pressure of all staff members. The recommendations of American Heart Association blood pressure measurements are considered as follows: not consuming caffeinated drinks and not smoking 30 minutes before taking blood pressure; being seated comfortably five minutes before measurement; having both arms supported at heart level and having both legs on the floor; silence during blood pressure measurement; deflating cuff at appropriate speed, and having the barometer at eye level of the observer. Cuff pressure will be filled with air until the pressure reaches 30 millimeter Hg above the level that radial pulse disappears.&#13;
The mean arterial blood pressure will be assessed using analogue blood pressure (Easy Life, TXJ 30A, ????) and a stethoscope (Anestophon Riester, Germany) whose reliability and validity have already been confirmed. People with prehypertension and hypertension will be screened and those under medications or medical care will be excluded. &#13;
A multi-stage sampling technique will be employed. The sample society members enter the study voluntarily and 80 samples will be selected after screening. The samples are then divided into experimental and control groups using simple random sampling technique. &#13;
The research team tries to select samples who match in terms of level of education, age, and medical history. Informed written consents will be obtained from all participants. The data will be collected using a demographic questionnaire and an information data sheet. The experimental group will be informed of the schedule and location of self-care educational classes. The educational intervention will be held in groups through lecturing, having question and answer sessions, and distributing pamphlets for continuing education. People in the experimental group who have basic information about hypertension and control methods will be separated from others to attend different educational classes. The classes will be held for two consecutive weeks on one day in two hours (8-10 or 10-12 a.m.) for both groups (with and without basic information). The first session discusses signs, symptoms, and lifestyle changes and the second session involves discussions on topics such as the importance of regular use of medication, the necessity for regular blood pressure control, standard blood pressure measurement, and side effects of medications. The blood pressure of samples will be recorded two months following the intervention under the same conditions of the screening day. Intervention 2: The staff working at Hamedan University of Medical Sciences will be screened to identity people with hypertension and pre-hypertension. People in the experimental and control groups will be randomly assigned. The control group receives no intervention. The blood-pressure of the intervention and control groups will be measured following two months of the intervention and the results of the two groups will be compared.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Hosseinabad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran, Hamedan, Square Martyr Fahmideh, opposite the Mardom park, Hamedan University of Medical Sciences</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 81 3838 0320</telephone>
        <email>f.hoseynabadi@edu.umsha.ac.ir; fhosseinabad2000@gmail.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohsen Salavati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran, Hamedan, Square Martyr Fahmideh، opposite the Mardom  park,  Hamedan University of Medical Sciences</address>
        <city>Hamedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 81 3838 0320</telephone>
        <email>salavatimohsen42@yahoo.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The present quasi-experimental study intended to determine the impact of self-care education on controlling blood pressure among staff members of Hamedan University of Medical Sciences diagnosed with hypertension and per-hypertension. &#13;
A multi-stage sampling technique will be employed. The sample population members enter the study voluntarily and are screened and divided into experimental and control groups. The study population comprises all staff working at Hamedan University of Medical Sciences who are diagnosed with hypertension or per-hypertension. &#13;
Eighty patients who meet the inclusion criteria will be recruited from the study population.&#13;
The inclusion criteria are as follows: people with hypertension or per-hypertension working at Hamedan University of Medical Sciences; written informed consent for participation; aged 25-55 years, and not taking any medicines to control blood pressure. &#13;
The exclusion criteria are failure to obtain participant’s consent and absence from educational sessions. &#13;
Group educational interventions will be conducted by lecturing, having question-and-answer sessions, and providing pamphlets for continuing education. The two-hour educational classes will be held on two days in two consecutive weeks from 8 to 10 or from 10 to 12 a.m. This study will evaluate the impact of education on controlling blood pressure among people with hypertension or per-hypertension.</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I15.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other secondary hypertension</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The present quasi-experimental study starts with obtaining required permissions from the School of Nursing and Midwifery in Hamedan University of Medical Sciences. The researcher will attend Hamedan University of Medical Sciences, explain the research objectives, and call for participation to measure and record blood pressure of all staff members. The recommendations of American Heart Association blood pressure measurements are considered as follows: not consuming caffeinated drinks and not smoking 30 minutes before taking blood pressure; being seated comfortably five minutes before measurement; having both arms supported at heart level and having both legs on the floor; silence during blood pressure measurement; deflating cuff at appropriate speed, and having the barometer at eye level of the observer. Cuff pressure will be filled with air until the pressure reaches 30 millimeter Hg above the level that radial pulse disappears.&#13;
The mean arterial blood pressure will be assessed using analogue blood pressure (Easy Life, TXJ 30A, ????) and a stethoscope (Anestophon Riester, Germany) whose reliability and validity have already been confirmed. People with prehypertension and hypertension will be screened and those under medications or medical care will be excluded. &#13;
A multi-stage sampling technique will be employed. The sample society members enter the study voluntarily and 80 samples will be selected after screening. The samples are then divided into experimental and control groups using simple random sampling technique. &#13;
The research team tries to select samples who match in terms of level of education, age, and medical history. Informed written consents will be obtained from all participants. The data will be collected using a demographic questionnaire and an information data sheet. The experimental group will be informed of the schedule and location of self-care educational classes. The educational intervention will be held in groups through lecturing, having question and answer sessions, and distributing pamphlets for continuing education. People in the experimental group who have basic information about hypertension and control methods will be separated from others to attend different educational classes. The classes will be held for two consecutive weeks on one day in two hours (8-10 or 10-12 a.m.) for both groups (with and without basic information). The first session discusses signs, symptoms, and lifestyle changes and the second session involves discussions on topics such as the importance of regular use of medication, the necessity for regular blood pressure control, standard blood pressure measurement, and side effects of medications. The blood pressure of samples will be recorded two months following the intervention under the same conditions of the screening day.</i_keyword>
      <i_keyword>The staff working at Hamedan University of Medical Sciences will be screened to identity people with hypertension and pre-hypertension. People in the experimental and control groups will be randomly assigned. The control group receives no intervention. The blood-pressure of the intervention and control groups will be measured following two months of the intervention and the results of the two groups will be compared.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Blood pressure. Timepoint: Before the intervention, two months after intervention. Method of measurement: mm Hg , using a mercury 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>2016-07-03</approval_date>
        <contact_name>Hamedan University of Medical Sciences</contact_name>
        <contact_address>Iran, Hamedan, Square Martyr Fahmideh, opposite the Mardom  park, Hamedan University of Medical Sciences Hamedan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
