<?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>IRCT20180924041121N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-10-30</date_registration>
      <primary_sponsor>Bojnourd University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Quran on physiological parameters of the elderly</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Quran on physiological parameters of the elderly admitted in the medical departments</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-10-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/34160</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Supportive, Blinding description: The data analyzer is kept blind.</study_design>
      <phase>N/A</phase>
      <hc_freetext>physiological parameters of the elderly.</hc_freetext>
      <i_freetext>Intervention 1: After receiving written informed consent from them, the elderly will first be studied in the course of the study and how it will be done, and the independent variable effects (Quranic verses) on the dependent variable (physiological indicators) will be examined. Trying to collaborate with departmental officials, research units in less crowded rooms. Intervention will take place every day at a specified time. Since the lowest congestion time (visitation, visitation, nursing, medication, etc.) is at the beginning of the night shift, the intervention was carried out at 8-9 nights. For the units of research in the intervention group, the voice The Qur'an, with the voice of the Master, is derived from Sura Yusuf verses 1 through 50 through headphones for 15 minutes, with the intensity adjusted according to the desire of the elderly. This intervention is performed in 15 minutes and only once. The vital signs of the elderly (pulse, respiration, blood pressure and temperature) are measured immediately before intervention and immediately after intervention.y adjusted according to the desire of the elderly. This intervention takes place within 15 minutes and only one partner.Intervention group:. Intervention 2: In the control group, the vital signs of the elderly are monitored and recorded immediately before and after 15 minutes of usual care. (It is necessary to explain that in order to remove the effect of the researcher in the Qur'anic voice group, the control group is also accompanied by the researcher during the study and if necessary, they will receive the standard care received in the control group)Control 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 No more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fariman Ebrahimzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Central Building of North Khorasan University of Medical Sciences, Government Boulevard, Bojnourd</address>
        <city>Bojnord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>74877-94149</zip>
        <telephone>+98 58 3151</telephone>
        <email>f.ebrahimzadeh@nkums.ac.ir</email>
        <affiliation>Bojnourd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fariman Ebrahimzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Central Building of North Khorasan University of Medical Sciences, Government Boulevard, Bojnourd</address>
        <city>Bojnord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>74877-94149</zip>
        <telephone>+98 58 3151</telephone>
        <email>f.ebrahimzadeh@nkums.ac.ir</email>
        <affiliation>Bojnourd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Elderly women and men over 60 years of age
Not having a hearing problem (history of using cognoscope, ear surgery, curettage, tinnitus, working in a noisy environment, not receiving an autosomalous drug for more than a week, etc.)
Non-development of diseases that chronicly disturb vital signs
Not having acute mental illness
Not having cognitive impairment
Not taking blood pressure medication</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Elderly reluctance to continue studying
Acute illness</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>After receiving written informed consent from them, the elderly will first be studied in the course of the study and how it will be done, and the independent variable effects (Quranic verses) on the dependent variable (physiological indicators) will be examined. Trying to collaborate with departmental officials, research units in less crowded rooms. Intervention will take place every day at a specified time. Since the lowest congestion time (visitation, visitation, nursing, medication, etc.) is at the beginning of the night shift, the intervention was carried out at 8-9 nights. For the units of research in the intervention group, the voice The Qur'an, with the voice of the Master, is derived from Sura Yusuf verses 1 through 50 through headphones for 15 minutes, with the intensity adjusted according to the desire of the elderly. This intervention is performed in 15 minutes and only once. The vital signs of the elderly (pulse, respiration, blood pressure and temperature) are measured immediately before intervention and immediately after intervention.y adjusted according to the desire of the elderly. This intervention takes place within 15 minutes and only one partner.Intervention group:</i_keyword>
      <i_keyword>In the control group, the vital signs of the elderly are monitored and recorded immediately before and after 15 minutes of usual care. (It is necessary to explain that in order to remove the effect of the researcher in the Qur'anic voice group, the control group is also accompanied by the researcher during the study and if necessary, they will receive the standard care received in the control group)Control group:</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The heart rate pulse or heart rate controlled by the researcher in the radial wrist in one minute immediately before the start and immediately after the interruption of the hearing is audible. Timepoint: immediately before intervention and immediately after intervention. Method of measurement: Hours of sentiment.</prim_outcome>
      <prim_outcome>The number of breathing or counting the number of movements of the chest wall (one full tail and exhalation) of the elder in one full minute. Timepoint: immediately before intervention and immediately after intervention. Method of measurement: Counting the chest movements in a perfect minute by the researcher.</prim_outcome>
      <prim_outcome>Elderly blood pressure. Timepoint: immediately before intervention and immediately after intervention. Method of measurement: Pressure gauge.</prim_outcome>
      <prim_outcome>The temperature of the elderly body. Timepoint: immediately before intervention and immediately after intervention. Method of measurement: Mercury Therommeter.</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>Bojnourd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-09-09</approval_date>
        <contact_name>Ethics committee ofNorth Khorasan University of Medical Sciences</contact_name>
        <contact_address>Nk. 193, West Varzesh Shirvan North Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
