<?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>IRCT20180427039439N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-12-28</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of listening to the voice of Quran on anxiety and depression of eldelry .</public_title>
      <acronym></acronym>
      <scientific_title>The effect of listening to the voice of Quran on anxiety and depression of eldelry .</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-04-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/35968</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The population of the study consisted of all elderly people living in the elderly home of Shiraz and the White Jasmines nursing home in Shiraz in 1397. The number of them is 220 people. The reason for choosing these two centers is the presence of elderly men and women in a center. After The questionnaires were filled out among eligible elderly people in order to enter the study, 41 elderly home of Shiraz and 19 elderly of White Jasmines nursing home were selected randomly by random number method and then by  Random block method and random allocation software  the elderly people put  in two groups of control and test each The number of group is 30 elderly, Blinding description: Two researcher assistance was used to collect data, one of which collected the data before intervention, and the other data collected after the intervention, and none of the control and test groups were known.
Data analysis was performed by a statistic consultant, which was not known in either control or test groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Anxiety, depression.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: in the Intervention group, the surah of Maryam (verses 1 through 69) with the voice of the Parhizgar (34 and 35) and simultaneous translation of the Fuladvand with each night before bedtime for 30 minutes; via MP3player and headphones (to remove additional sounds) for each elderly person , Is broadcast for one month. Intervention 2: Control group: There is no intervention for the elderly in the control group and only routine care provided by the caretakers of the nursing home.</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 participants' data file will contain the information on the main outcome and the protocol for the implementation of the study, and the clinical study report and the informed consent form will be shared.

When:
6 months after printing results.

To whom:
Will be available to the general public.

Conditions:
If the data are used, the origin of the loan must be respected and, if used in other studies, reference is required.

Where to obtain:
Applying to the following email address:
Anursing862@gmail.com

How to obtain:
First, a transparent request, containing the reasons for requesting information, how they are used and where they are located, are provided and after a review of about a month and verification of the profile, the information is sent.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Arash Ghasemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing, Hazrat Fatemeh</address>
        <city>Shiraze</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>13119 71936</zip>
        <telephone>+98 83 3726 3053</telephone>
        <email>Anursing862@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Arash Ghasemi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing, Hazrat Fatemeh</address>
        <city>Shiraze</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7193613119</zip>
        <telephone>+98 83 3726 3053</telephone>
        <email>Anursing862@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age over 60 years old
Inclination to participate in research
Anxiety and depression
Do not take antidepressants or anti-anxiety drugs
Do not have Cognitive Disorders</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Being in critical condition such as the death of one of the relatives
Participate in similar workshops and training
Do not listen to the Quran's voice by  elderly for the at 5 consecutive nights or 10 nights apart during the month
Elderly Hearing Disorders
Completed incomplete questionnaire</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F41.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Mixed anxiety and depressive disorder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: in the Intervention group, the surah of Maryam (verses 1 through 69) with the voice of the Parhizgar (34 and 35) and simultaneous translation of the Fuladvand with each night before bedtime for 30 minutes; via MP3player and headphones (to remove additional sounds) for each elderly person , Is broadcast for one month.</i_keyword>
      <i_keyword>Control group: There is no intervention for the elderly in the control group and only routine care provided by the caretakers of the nursing home.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety: In this study, anxiety was obtained by earning a minimum score of 20 from Spilberger's apparent and hidden anxiety questionnaire. Timepoint: Complete Spilberger's apparent and hidden anxiety questionnaire Before and After Intervention within one month. Method of measurement: Spilberger's apparent and hidden anxiety questionnaire.</prim_outcome>
      <prim_outcome>Depression: In this study, depression was defined as the minimum score of 10 in the geriatric depression scale. Timepoint: Complete the Geriatric Depression Scale before and after the intervention within one month. Method of measurement: Geriatric depression 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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-10-02</approval_date>
        <contact_name>•Ethics committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Namazi Square, Faculty of Nursing, Hazrat Fatemeh Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
