<?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>IRCT20250518065790N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-07-19</date_registration>
      <primary_sponsor>Jahrom University of Medical Sciences</primary_sponsor>
      <public_title>Training based on the Pender model on perceived stress and sleep quality in elderly people with hypertension</public_title>
      <acronym></acronym>
      <scientific_title>Studying the effect of educational intervention based on the Pender model on perceived stress and sleep quality of elderly people with hypertension</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>66</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/83639</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In this study, block randomization method will be used using a random number table. Block randomization with a block size of 4 with equal probability for eligible elderly people to the intervention (group B) and control (group A) groups will be used. Given the block size of 4, there will be 6 possible combinations of group assignments including: ABAB, AABB, BBAA, BABA, BAAB, ABBA. First, one of the arrangements will be randomly selected and four eligible elderly people will be assigned to each block in order. This process will be repeated many times until eligible elderly people are included.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Blood pressure.</hc_freetext>
      <i_freetext>Intervention 1: Intervention Group: Participants in the intervention group will attend one 45-minute educational session per week for six consecutive weeks (a total of six sessions). These sessions will be designed based on the Pender Health Promotion Model and will be delivered in groups of eight in the clinic’s classroom.The content of the sessions will include:Stress management using relaxation techniques (e.g., deep breathing and progressive muscle relaxation),Improving sleep quality through sleep hygiene education,Strengthening self-efficacy in performing healthy behaviors,Promoting daily health-related behaviors.The training will be delivered by the researcher through direct instruction and PowerPoint slides. Interactive methods such as group discussion, Q&amp;A, and practical exercises will be used in each session. At the end of each session, an educational brochure related to the topic will be provided to participants. Sessions will be held in the clinic’s education room equipped with audiovisual facilities, comfortable seating, appropriate lighting, and controlled temperature. No medication or chemical substances will be used. Intervention 2: Control group: Participants in the control group will receive only routine clinic care during the study period, including regular doctor visits, vital signs checks, and general health monitoring. No additional educational interventions will be provided to this group. At the end of the study, in order to comply with ethical principles, a summary of the educational content will also be provided to this group.</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 A decision will be made after the article is published.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Reihaneh Sepehr</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pardis Campus, Jahrom University of Medical Sciences, After Nursing School, Ostad Motahari Street, Jahrom, Fars Province, Iran</address>
        <city>Jahrom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7414846199</zip>
        <telephone>+98 71 5447 5608</telephone>
        <email>Reresep5@gmail.com</email>
        <affiliation>Jahrom University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Dehghani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pardis Campus, Jahrom University of Medical Sciences, After Nursing School, Ostad Motahari Street, Jahrom, Fars Province, Iran</address>
        <city>Jahrom</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7414846199</zip>
        <telephone>+98 71 5447 5608</telephone>
        <email>Ali.Dehghani2000@gmail.com</email>
        <affiliation>Jahrom University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Individuals over 60 years old.
The ability to speak, read, and write in Persian.
diagnosed with grade 1 or 2 hypertension by a cardiologist. Stage 1 hypertension includes systolic blood pressure of 140-159 or diastolic blood pressure of 90-99, and stage 2 hypertension involves systolic blood pressure equal to or greater than 160 or diastolic blood pressure equal to or greater than 100.
participants must have a willingness to take part in the study.</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Participation in educational programs in the past six months
Individuals who use hydrotherapy and massage therapy.
Individuals who are immobile
"Individuals who consume alcohol and caffeine</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R03</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Abnormal blood-pressure reading, without diagnosis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention Group: Participants in the intervention group will attend one 45-minute educational session per week for six consecutive weeks (a total of six sessions). These sessions will be designed based on the Pender Health Promotion Model and will be delivered in groups of eight in the clinic’s classroom.The content of the sessions will include:Stress management using relaxation techniques (e.g., deep breathing and progressive muscle relaxation),Improving sleep quality through sleep hygiene education,Strengthening self-efficacy in performing healthy behaviors,Promoting daily health-related behaviors.The training will be delivered by the researcher through direct instruction and PowerPoint slides. Interactive methods such as group discussion, Q&amp;A, and practical exercises will be used in each session. At the end of each session, an educational brochure related to the topic will be provided to participants. Sessions will be held in the clinic’s education room equipped with audiovisual facilities, comfortable seating, appropriate lighting, and controlled temperature. No medication or chemical substances will be used.</i_keyword>
      <i_keyword>Control group: Participants in the control group will receive only routine clinic care during the study period, including regular doctor visits, vital signs checks, and general health monitoring. No additional educational interventions will be provided to this group. At the end of the study, in order to comply with ethical principles, a summary of the educational content will also be provided to this group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sleep Quality. Timepoint: Before the intervention, immediately and one month after the intervention. Method of measurement: Pitsburgh Sleep Quality Questionnaire.</prim_outcome>
      <prim_outcome>Perceived stress. Timepoint: Before the intervention, immediately and one month after the intervention. Method of measurement: Cohen's Perceived Stress 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>Jahrom University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-05-17</approval_date>
        <contact_name>Research Ethics Committees of Jahrom University of Medical Sciences</contact_name>
        <contact_address>Pardis Site, Jahrom University of Medical Sciences, Ostad Motahari Street, Jahrom, Fars Province, Iran Jahrom Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
