<?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>IRCT20150519022320N27</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-02-06</date_registration>
      <primary_sponsor>Rafsanjan University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the effect of self-care education based on Orem model with acceptance and commitment therapy on lifestyle of patients with hypertension.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of self-care education based on Orem model with acceptance and commitment therapy on lifestyle of patients with hypertension.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/62168</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: After identifying the depressed elderly according to the inclusion criteria and its listing, they will be divided into 3 groups of 40 people A, B and C by simple random division using a table of random numbers and then the groups will be divided again by simple random division. On each group (2 intervention groups and one control group) it will be determined what intervention will be done on each group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>hypertention.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the education group according to the Orem model, after random allocation, expression of goals and gaining patients 'satisfaction, first the patients' self-care needs based on the forms of examination and recognition of Orem including self-care needs based on the Orom model (including 44 cases in three dimensions: general self-care needs, needs Self-care and self-care needs have been deviated from health). After determining the needs of patients, a self-care program will be developed which will be held in groups in 8 sessions of 90 minutes through discussion for patients in the experimental group. Attention to the stage of reviewing and recognizing the needs of self-care based on the Orem model will be designed and developed in the form of educational-supportive nursing care program, and after creating the needs, appropriate educational materials will be evaluated. And then will be approved by a cardiologist. The training content will be taught in eight 90-minute sessions for one month. Training will be done in groups. During this time, patients will be contacted regularly via mobile phone. At the end of each session, a training pamphlet in accordance with the training given to patients will be given and during the week the patient will be monitored by phone for the training given and the researcher number will be given to the patient. At the end of these four weeks, patients will complete a lifestyle questionnaire. Intervention 2: Intervention group: Intervention group: Interventions in the acceptance and commitment group training group will be held in 8 sessions of 90 minutes, twice a week for a month by a group psychologist based on the model of Hayes, Stroessel and Wilson and at the end of each A session of an educational pamphlet will be given to the individual in accordance with the training given. During the week, the researcher will communicate with patients by telephone. And the researcher number will be given to individuals. At the end of the sessions, patients will complete a lifestyle questionnaire. The questionnaires will be completed again eight weeks after the interventions. Intervention 3: Control group: Control group: There will be no intervention in the control group during the study period. Only routine care will be provided and questionnaires will be completed by individuals.</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 further information available</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Ali Ravary</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing, Nurse blvd., Jomhury street, Rafsanjan</address>
        <city>Rafsanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7718174715</zip>
        <telephone>+98 34 3428 0038</telephone>
        <email>ravary4776@yahoo.com</email>
        <affiliation>Rafsanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Ali Ravari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing, Nurse blvd., Jomhury street, Rafsanjan</address>
        <city>Rafsanjan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7718174715</zip>
        <telephone>+98 34 3428 0038</telephone>
        <email>ravary4776@yahoo.com</email>
        <affiliation>Rafsanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The certainty of having uncontrolled blood pressure through the control of blood pressure recorded in the previous three periods
Having an age range of 40 years and above
Having a phone and knowing how to use it
Ability to participate in training sessions
Minimum primary education
No known mental illness
Willingness to participate in the project</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Non-cooperation based on training programs
Hospitalization during the research period
Consecutive absence in two sessions or absence in a quarter of all sessions
Suffering from diseases that force the patient to take blood pressure medications during research</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I10</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Essential (primary) hypertension</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the education group according to the Orem model, after random allocation, expression of goals and gaining patients 'satisfaction, first the patients' self-care needs based on the forms of examination and recognition of Orem including self-care needs based on the Orom model (including 44 cases in three dimensions: general self-care needs, needs Self-care and self-care needs have been deviated from health). After determining the needs of patients, a self-care program will be developed which will be held in groups in 8 sessions of 90 minutes through discussion for patients in the experimental group. Attention to the stage of reviewing and recognizing the needs of self-care based on the Orem model will be designed and developed in the form of educational-supportive nursing care program, and after creating the needs, appropriate educational materials will be evaluated. And then will be approved by a cardiologist. The training content will be taught in eight 90-minute sessions for one month. Training will be done in groups. During this time, patients will be contacted regularly via mobile phone. At the end of each session, a training pamphlet in accordance with the training given to patients will be given and during the week the patient will be monitored by phone for the training given and the researcher number will be given to the patient. At the end of these four weeks, patients will complete a lifestyle questionnaire.</i_keyword>
      <i_keyword>Intervention group: Intervention group: Interventions in the acceptance and commitment group training group will be held in 8 sessions of 90 minutes, twice a week for a month by a group psychologist based on the model of Hayes, Stroessel and Wilson and at the end of each A session of an educational pamphlet will be given to the individual in accordance with the training given. During the week, the researcher will communicate with patients by telephone. And the researcher number will be given to individuals. At the end of the sessions, patients will complete a lifestyle questionnaire. The questionnaires will be completed again eight weeks after the interventions.</i_keyword>
      <i_keyword>Control group: Control group: There will be no intervention in the control group during the study period. Only routine care will be provided and questionnaires will be completed by individuals.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Lifestyle of patients with hypertension. Timepoint: All individuals will complete a health-promoting lifestyle questionnaire at the beginning and then at the end of the intervention, and eight weeks after the intervention. Method of measurement: HPLP Health Promoting Lifestyle 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>Rafsanjan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-11-22</approval_date>
        <contact_name>Research Ethics Committee of Rafsanjan University of Medical Sciences</contact_name>
        <contact_address>School of Nursing and Midwifery, Nurse Avenue, Rafsanjan Rafsanjan Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
