<?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>IRCT20150519022320N28</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>Investigating the effect of spiritual group therapy on perceived stress, mental rumination and sleep quality of the elderly</public_title>
      <acronym></acronym>
      <scientific_title>The effect of spiritual group therapy on perceived stress, mental rumination and sleep quality of the elderly referring to comprehensive health service centers in Rafsanjan in 2023</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-02-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>44</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68050</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Simple randomization. Sampling will be done in an accessible (easy) method, and the allocation of research units to two intervention and control groups will be random using a simple randomization method (random number table).</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Sleep disorder. Condition 2: perceived stress. Condition 3: rumination.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The researcher will start the work after stating the goals and method of the study and obtaining the consent of the people to participate in the study. Data collection tools include: 1. Demographic Information Questionnaire 2. Nolen Hoeksma's Mental Rumination Questionnaire 3. Cohen's Perceived Stress Scale 4. Pittsburgh Sleep Quality Index Questionnaire For the intervention group, spiritual care sessions will be held twice a week for 45 to 60 minutes in 8 sessions by the researcher. Holding 8 sessions for 4 weeks and two sessions each week: First session: introduction and getting to know the participants and distribution of demographic information questionnaires, mental rumination, perceived stress and sleep quality. Getting the contact number and setting the next appointment, building trust to establish contact. The second session: talking and discussing about spiritual issues and how it affects life and coping with life's problems and concerns. The third session: talking about existential truth and meaning in life. , challenging irrational thoughts, talking about God and any higher power that the client believes in. The fourth session: Examining religious and spiritual teachings regarding stress and connection with the saints. The fifth session: Examining irrational thoughts about feelings of guilt and resentment and The lack of self-forgiveness and the role of the sound of the Qur'an in sound sleep. The sixth session: Faith and trust in God and its role in reducing stress. Summarizing the contents of the previous sessions, re-completing the rumination questionnaire and perceived stress and sleep quality, and the last 10 minutes of each session are spent reviewing the reports related to these tasks and answering the questions. Intervention 2: Control group: The control group will be formed by the Whats App group for 4 weeks by the researcher and will explain the problems that will occur in the aging process and will answer their medical questions and problems.</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.Tayebeh Mirzaei</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>t.mirzaei@rums.ac.ir</email>
        <affiliation>Rafsanjan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Tayebe Mirzaei</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>T.Mirzaei@rums.ac.ir</email>
        <affiliation>Rafsanjan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 60 years old or older
Not having acute physical and mental illness
Ability to participate in research
Not having cognitive problems such as Alzheimer's disease, stroke, and transient brain attack
Willing to participate in the study
At least literate in reading and writing
Not having hearing impairment according to the individual's self-report of having a sleep disorder based on getting a score higher than 5 in the Pittsburgh Questionnaire</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>A person's refusal to participate in spiritual care programs
Not attending three sessions of the programs and the death of the elderly</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The researcher will start the work after stating the goals and method of the study and obtaining the consent of the people to participate in the study. Data collection tools include: 1. Demographic Information Questionnaire 2. Nolen Hoeksma's Mental Rumination Questionnaire 3. Cohen's Perceived Stress Scale 4. Pittsburgh Sleep Quality Index Questionnaire For the intervention group, spiritual care sessions will be held twice a week for 45 to 60 minutes in 8 sessions by the researcher. Holding 8 sessions for 4 weeks and two sessions each week: First session: introduction and getting to know the participants and distribution of demographic information questionnaires, mental rumination, perceived stress and sleep quality. Getting the contact number and setting the next appointment, building trust to establish contact. The second session: talking and discussing about spiritual issues and how it affects life and coping with life's problems and concerns. The third session: talking about existential truth and meaning in life. , challenging irrational thoughts, talking about God and any higher power that the client believes in. The fourth session: Examining religious and spiritual teachings regarding stress and connection with the saints. The fifth session: Examining irrational thoughts about feelings of guilt and resentment and The lack of self-forgiveness and the role of the sound of the Qur'an in sound sleep. The sixth session: Faith and trust in God and its role in reducing stress. Summarizing the contents of the previous sessions, re-completing the rumination questionnaire and perceived stress and sleep quality, and the last 10 minutes of each session are spent reviewing the reports related to these tasks and answering the questions.</i_keyword>
      <i_keyword>Control group: The control group will be formed by the Whats App group for 4 weeks by the researcher and will explain the problems that will occur in the aging process and will answer their medical questions and problems.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Response score to Cohen's perceived stress scale. Timepoint: Before, immediately and one month after the end of the intervention. Method of measurement: Cohen's Perceived Stress Questionnaire.</prim_outcome>
      <prim_outcome>Response score to Nolen Hoeksma's mental rumination questionnaire. Timepoint: Before, immediately and one month after the end of the intervention. Method of measurement: Nalan Hoeksma mental rumination questionnaire.</prim_outcome>
      <prim_outcome>Sleep quality. Timepoint: Before, immediately and one month after the end of the intervention. Method of measurement: Elderly Sleep Quality Scale.</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>2022-10-08</approval_date>
        <contact_name>Research Ethics Committee of Rafsanjan University of Medical Sciences</contact_name>
        <contact_address>Rafsanjan, Imam Ali Blvd. Central Office of Rafsanjan University of Medical Sciences rafsanjan Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
