<?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>IRCT20250611066184N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-10-07</date_registration>
      <primary_sponsor>Fasa University of Medical Sciences</primary_sponsor>
      <public_title>the effect of spiritual care based on GALB SALIM model on quality of life and psychological well – being of elderly with hypertension</public_title>
      <acronym></acronym>
      <scientific_title>the effect of spiritual care based on GALB SALIM model on quality of life and psychological well – being of elderly with hypertension</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-10-31</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/86164</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Individuals will be divided into study groups using a randomization method based on random block permutation. First, a four-word block is generated, from which 12 blocks are selected using Excel software, and individuals are placed into two intervention and control groups based on the block codes.</study_design>
      <phase>4</phase>
      <hc_freetext>Elderly with High blood pressure.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Before the intervention, the demographic checklist, Quality of Life Questionnaire, and Psychological Well-being Questionnaire are completed by the intervention group. For the intervention group, an educational spiritual care intervention based on the ‘Sound Heart Model’ will be conducted, consisting of 9 mixed educational sessions (in-person and virtual). At the beginning of the study, all participants will join a WhatsApp group where supplementary materials will be shared and their questions answered. Additionally, an educational booklet will be prepared and distributed to the intervention group during the study. The first session focuses on familiarization and building rapport with the participants, discussing the study’s objective, the timing and number of educational classes, the study process, and the necessity of strengthening moral virtues. The second session addresses the positive aspects of challenges and educates participants on the concept of spiritual health, characteristics of individuals with a ‘Sound Heart,’ the impact of spiritual health on various dimensions of well-being, and methods to achieve spiritual health. The third session teaches problem-solving skills and essential skills for lifestyle modification. The fourth session emphasizes self-connection, providing education on hypertension (disease symptoms, complications, risk factors, appropriate diet and activity, etc.), and also discusses human dignity and the story of human creation with divine love, starting with Adam. The fifth session focuses on connection with God, playing audio files of prayers and the Quran. Recommendations are also made for prayer and supplication, performing daily prayers (Salat), reciting the Quran, and narrating Quranic stories. The sixth session (connection with others) teaches about visiting relatives, paying attention to one’s spouse and children, laughter and cheerfulness, charity (infaq), forgiveness, and showing love to others. In the seventh session (connection with nature), patients are advised to observe flowing water, trees, and flowers, to smell them, cultivate flowers, and show compassion to animals, etc. Additionally, pleasant sounds such as rain, flowing water, and bird songs are played. In the eighth session, the patient’s values and motivations are identified, and assistance is sought from the patient’s closest individual to foster motivation. In the ninth and final session, illustrative anecdotes are used to give meaning to life events, self-control skills are taught, and finally, patients’ opinions on the classes and their impact on their lives are evaluated. Immediately and one month after the educational classes, the Quality of Life and Psychological Well-being questionnaires are re-completed by the individuals. Intervention 2: Control group: Initially, individuals in this group complete the demographic checklist, Quality of Life Questionnaire, and Psychological Well-being Questionnaire. The control group does not receive any training. Immediately and one month after the educational sessions (of the intervention group), this group will re-complete the Quality of Life and Psychological Well-being questionnaires.</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:
All data can be shared after the individuals participating in the study are de-identified.

When:
Access begins four months after results are published.

To whom:
Researchers working in academic institutions

Conditions:
To write meta-analysis studies

Where to obtain:
Dr. Azam Zare,  Fasa University of Medical Sciences

How to obtain:
Send a written request

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Azam Zare</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Abn Sina Squre</address>
        <city>Fasa</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>74616_86688</zip>
        <telephone>+98 71 5335 4990</telephone>
        <email>a.zare2002@gmail.com</email>
        <affiliation>Fasa University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Azam Zare</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Abn Sina Squre</address>
        <city>Fasa</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>74616_ 86688</zip>
        <telephone>+98 71 5335 0994</telephone>
        <email>a.zare2002@gmail.com</email>
        <affiliation>Fasa University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>People over 60 years old
Suffering from high blood pressure
Not having a serious illness such as cancer
Not having a mental illness
No drug use
Ability to read and write
Willingness to participate in the study
Not being deaf or blind
Self-awareness of current illness</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Participating in a similar study
Absence from more than one training session
Reluctance to cooperate</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I10_115</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Hypertensive diseases</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: Before the intervention, the demographic checklist, Quality of Life Questionnaire, and Psychological Well-being Questionnaire are completed by the intervention group. For the intervention group, an educational spiritual care intervention based on the ‘Sound Heart Model’ will be conducted, consisting of 9 mixed educational sessions (in-person and virtual). At the beginning of the study, all participants will join a WhatsApp group where supplementary materials will be shared and their questions answered. Additionally, an educational booklet will be prepared and distributed to the intervention group during the study. The first session focuses on familiarization and building rapport with the participants, discussing the study’s objective, the timing and number of educational classes, the study process, and the necessity of strengthening moral virtues. The second session addresses the positive aspects of challenges and educates participants on the concept of spiritual health, characteristics of individuals with a ‘Sound Heart,’ the impact of spiritual health on various dimensions of well-being, and methods to achieve spiritual health. The third session teaches problem-solving skills and essential skills for lifestyle modification. The fourth session emphasizes self-connection, providing education on hypertension (disease symptoms, complications, risk factors, appropriate diet and activity, etc.), and also discusses human dignity and the story of human creation with divine love, starting with Adam. The fifth session focuses on connection with God, playing audio files of prayers and the Quran. Recommendations are also made for prayer and supplication, performing daily prayers (Salat), reciting the Quran, and narrating Quranic stories. The sixth session (connection with others) teaches about visiting relatives, paying attention to one’s spouse and children, laughter and cheerfulness, charity (infaq), forgiveness, and showing love to others. In the seventh session (connection with nature), patients are advised to observe flowing water, trees, and flowers, to smell them, cultivate flowers, and show compassion to animals, etc. Additionally, pleasant sounds such as rain, flowing water, and bird songs are played. In the eighth session, the patient’s values and motivations are identified, and assistance is sought from the patient’s closest individual to foster motivation. In the ninth and final session, illustrative anecdotes are used to give meaning to life events, self-control skills are taught, and finally, patients’ opinions on the classes and their impact on their lives are evaluated. Immediately and one month after the educational classes, the Quality of Life and Psychological Well-being questionnaires are re-completed by the individuals.</i_keyword>
      <i_keyword>Control group: Initially, individuals in this group complete the demographic checklist, Quality of Life Questionnaire, and Psychological Well-being Questionnaire. The control group does not receive any training. Immediately and one month after the educational sessions (of the intervention group), this group will re-complete the Quality of Life and Psychological Well-being questionnaires.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of life. Timepoint: Before, After, 1Month Later. Method of measurement: To assess the quality of life of elderly people with high blood pressure, a specific questionnaire for the quality of life in people with high blood pressure was designed by Shamsi and Dehghan Nayiri in 2022. This questionnaire is in accordance with the culture and customs of Iranian society.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Psychological well-being. Timepoint: Before, After,1 Month Later. Method of measurement: The Psychological Well-Being Questionnaire was designed by Riff in 1989. The components of this questionnaire include: self-acceptance, positive relationships with others, autonomy, purposeful living, personal growth, and mastery of the environment, which has 18 questions. Latifi et al. standardized this questionnaire in Iran.</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>Fasa University of medical sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-09-22</approval_date>
        <contact_name>Ethics committee of fasa University of medical sciences</contact_name>
        <contact_address>Abn Sina Squre Fasa Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
