<?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>IRCT20090304001742N15</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-08-22</date_registration>
      <primary_sponsor>Larestan University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of a Spiritual Intervention Based on the Ghalbe Salim Model on Resilience and Anxiety Among Prehospital Emergency Medical Services</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of a Spiritual Intervention Based on the Ghalbe Salim Model on Resilience and Anxiety Among Prehospital Emergency M.edical Services Personnel</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-08-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/92461</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The samples of this study will be selected from among the personnel working in the pre-hospital emergency department of Lar University of Medical Sciences who meet the inclusion criteria, using simple random sampling. To this end, after preparing a list of eligible individuals, a code will be assigned to each person, and the samples will be selected using random number generation/draw. After obtaining informed consent from the selected individuals, in order to reduce the effect of individual differences and control bias, the participants will be allocated to intervention and control groups using simple random allocation, Blinding description: The raw data will be provided to the statistical analyst in coded form (under the headings of Group A and Group B), and he will be unaware of the true identity of the intervention and control groups until the end of the statistical analysis stages.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Anxiety.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: After sampling, individuals will be randomly assigned to two intervention and control groups. The intervention group consists of 35 individuals who will receive 6 90-minute sessions of the Healthy Heart-based spiritual intervention. Session 1: Introduction, spirituality, and self-awareness. In this session, participants are introduced to the research objectives, the intervention framework, and the concept of "Healthy Heart." Spirituality is introduced as an internal resource for coping with stress, and its role in reducing anxiety and increasing resilience is explained. Spiritual self-awareness is also addressed, and individuals are guided to identify their values, beliefs, and internal resources. In the practical part, a practice of focusing on breathing and paying attention to internal states (simple mindfulness based on paying attention to the heart) is performed, and participants are asked to record their daily experiences of stress and emotional reactions. Session 2: Recognizing and regulating emotions + positive thinking. This session is dedicated to integrating emotion recognition skills and cognitive restructuring. Participants learn to identify negative emotions (especially anxiety) in emergency situations and correct dysfunctional thoughts using simple cognitive techniques. Also, training in positive attitude, hope, and focusing on meaningful aspects of the job is provided. Practical practice includes recording negative thoughts and transforming them into adaptive thoughts and writing down daily positive points. Session Three: Acceptance, Patience, and Trust In this session, the key concepts of accepting reality, active patience, and trust are discussed as the main components of a healthy heart. Participants are taught how to reduce emotional resistance and achieve conscious acceptance when faced with uncontrollable circumstances (such as the death of a patient or severe events). The practical exercise involves reviewing a stressful experience, accepting it without judgment, and mentally practicing surrendering control to higher factors (in the form of trust), which helps reduce anxiety. Session Four: Empathy, Communication, and Spiritual Support This session emphasizes human relationships, empathy, and social support as sources of increased resilience. Participants are introduced to effective and empathetic communication skills and the role of positive communication in reducing stress and increasing a sense of meaning at work is examined. The practical exercise involves empathetic conversation, active listening, and providing positive feedback to colleagues, which strengthens a sense of belonging and reduces psychological stress. Session Five: Relaxation, Meaning-Seeking, and Heart Connection This session is a combination of relaxation and meaning-seeking techniques. Participants are introduced to physical and mental stress reduction techniques including deep breathing, muscle relaxation, and focusing on the heart. Next, the concept of meaning in emergency work is introduced and individuals are guided to redefine difficult experiences in terms of meaning and value. Practical exercises include guided breathing, focusing on the heart, and writing about a meaningful work experience. Session 6: Integration, consolidation, and future planning In the final session, all the skills and concepts taught are reviewed and integrated. Participants learn how to apply these skills in their daily lives and work environments. An individualized plan is designed to continue the exercises and participants share their experiences. This session aims to consolidate learning, increase self-efficacy, and sustain the effects of the intervention. The content of the spiritual intervention sessions is designed based on existing evidence on the impact of spirituality on mental health, and the duration of the course is approximately 45 days. Intervention 2: Control Group: The control group consists of 35 participants who will only complete the pre-test and post-test and will not receive any intervention. Anxiety levels will be measured using the Beck Anxiety Inventory (BAI) in both the pre-test and post-test. Resilience will be measured using the Connor-Davidson Resilience Scale (CD-RISC) in both the pre-test and post-test.</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:
The names of the participants are strictly confidential and cannot be published. However, the results of the study will be made public.

When:
2027

To whom:
public

Conditions:
Referring to the name of the source and researcher

Where to obtain:
Email

How to obtain:
Send request by email, wait for review and response, confirm and send in the same mail

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Mohammad Rafi Bazrafshan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Research Management, Larestan university of medical sciences, Velayat Boulevard, Imam Khomeini Square, larestan , Iran</address>
        <city>Lar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7431895639</zip>
        <telephone>0098  52255512</telephone>
        <email>mrbazr@sums.ac.ir</email>
        <affiliation>Larestan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Rafi Bazrafshan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Research Management, Larestan university of medical sciences, Velayat Boulevard, Imam Khomeini Square, larestan , Iran</address>
        <city>Lar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7431895639</zip>
        <telephone>+98 71 5255 5512</telephone>
        <email>mrbazr@sums.ac.ir</email>
        <affiliation>Larestan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Formal or contractual employment in the prehospital emergency department of Larestan Faculty of Medical Sciences
At least one year of work experience in the prehospital emergency
Informed consent and willingness to participate in research
No diagnosed psychiatric disorders (based on self-report)
Not taking psychotropic drugs (based on the individual's statement)
Not participating in other similar intervention programs at the same time
The score obtained from the BAI questionnaire should be in the range of zero to 7.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Unwillingness to continue cooperation at any stage of the research
Absence from more than 1 intervention session (without attending the anticipated make-up session)
Occurrence of physical or mental conditions that prevent continued participation in the research</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F06.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Anxiety disorder due to known physiological condition</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: After sampling, individuals will be randomly assigned to two intervention and control groups. The intervention group consists of 35 individuals who will receive 6 90-minute sessions of the Healthy Heart-based spiritual intervention. Session 1: Introduction, spirituality, and self-awareness. In this session, participants are introduced to the research objectives, the intervention framework, and the concept of "Healthy Heart." Spirituality is introduced as an internal resource for coping with stress, and its role in reducing anxiety and increasing resilience is explained. Spiritual self-awareness is also addressed, and individuals are guided to identify their values, beliefs, and internal resources. In the practical part, a practice of focusing on breathing and paying attention to internal states (simple mindfulness based on paying attention to the heart) is performed, and participants are asked to record their daily experiences of stress and emotional reactions. Session 2: Recognizing and regulating emotions + positive thinking. This session is dedicated to integrating emotion recognition skills and cognitive restructuring. Participants learn to identify negative emotions (especially anxiety) in emergency situations and correct dysfunctional thoughts using simple cognitive techniques. Also, training in positive attitude, hope, and focusing on meaningful aspects of the job is provided. Practical practice includes recording negative thoughts and transforming them into adaptive thoughts and writing down daily positive points. Session Three: Acceptance, Patience, and Trust In this session, the key concepts of accepting reality, active patience, and trust are discussed as the main components of a healthy heart. Participants are taught how to reduce emotional resistance and achieve conscious acceptance when faced with uncontrollable circumstances (such as the death of a patient or severe events). The practical exercise involves reviewing a stressful experience, accepting it without judgment, and mentally practicing surrendering control to higher factors (in the form of trust), which helps reduce anxiety. Session Four: Empathy, Communication, and Spiritual Support This session emphasizes human relationships, empathy, and social support as sources of increased resilience. Participants are introduced to effective and empathetic communication skills and the role of positive communication in reducing stress and increasing a sense of meaning at work is examined. The practical exercise involves empathetic conversation, active listening, and providing positive feedback to colleagues, which strengthens a sense of belonging and reduces psychological stress. Session Five: Relaxation, Meaning-Seeking, and Heart Connection This session is a combination of relaxation and meaning-seeking techniques. Participants are introduced to physical and mental stress reduction techniques including deep breathing, muscle relaxation, and focusing on the heart. Next, the concept of meaning in emergency work is introduced and individuals are guided to redefine difficult experiences in terms of meaning and value. Practical exercises include guided breathing, focusing on the heart, and writing about a meaningful work experience. Session 6: Integration, consolidation, and future planning In the final session, all the skills and concepts taught are reviewed and integrated. Participants learn how to apply these skills in their daily lives and work environments. An individualized plan is designed to continue the exercises and participants share their experiences. This session aims to consolidate learning, increase self-efficacy, and sustain the effects of the intervention. The content of the spiritual intervention sessions is designed based on existing evidence on the impact of spirituality on mental health, and the duration of the course is approximately 45 days.</i_keyword>
      <i_keyword>Control Group: The control group consists of 35 participants who will only complete the pre-test and post-test and will not receive any intervention. Anxiety levels will be measured using the Beck Anxiety Inventory (BAI) in both the pre-test and post-test. Resilience will be measured using the Connor-Davidson Resilience Scale (CD-RISC) in both the pre-test and post-test.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety disorder is one of the most common mental health problems worldwide, significantly affecting a person's mental health and functioning. Timepoint: Before the intervention and after the end of the intervention. Method of measurement: Beck Anxiety and Connor-Davidson Resilience Questionnaires.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Resilience. Timepoint: Before intervention and after intervention. Method of measurement: Beck Anxiety and Connor-Davidson Resilience Questionnaires.</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>Larestan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-07-22</approval_date>
        <contact_name>Ethics committee of Larestan University of Medical Sciences</contact_name>
        <contact_address>, Larestan university of medical sciences, Velayat Boulevard, Imam Khomeini Square, larestan , Iran Lar Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
