<?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>IRCT20171212037852N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-06-08</date_registration>
      <primary_sponsor>ْThe University of Mohaqeq Ardabili</primary_sponsor>
      <public_title>The Effectiveness of Music Therapy with Aerobic exercise in improvement of symptoms in Patients with Schizophrenia</public_title>
      <acronym></acronym>
      <scientific_title>The Effectiveness of Music Therapy with Aerobic exercise in Control of Positive and Negative Syndromes and Improving Sleep Quality in Patients with Schizophrenia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/39030</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Randomization description: The member of sample assigned in the experimental and control group by lottery.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Schizophrenic patients.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Music therapy. Before performing music therapy, the pre-test will be perform. Music therapy will hold in 8 sessions for four weeks (twice a week). Each session last 60 min. This intervention comprise of passive music interventions including music listening. The music use in this study include eight light music that play with an mp3 player attach to a speaker. During the intervention, the participants  should not draw or image to the music, but they will allow to talk about that after finishing the session. Patients will ask to concentrate on the music to become relaxed and lie in a bed or chair in comfortable position during the music therapy sessions. After performing music therapy, the post-test will be perform. Intervention 2: Intervention group: Aerobic exercise. Before performing the aerobic exercises, the pre-test will be perform. The aerobic exercise program consisted of eight exercise sessions over the course of four weeks. Each session of the aerobic exercise involve stretching the large muscle groups as a warm-up (10 min), performing the aerobic exercise during the main phase (40 min), and stretching the center-based muscle during a cool-down stage (10 min). After performing aerobic exercises, the post-test will be perform. Intervention 3: Intervention group: Music therapy with aerobic exercise. In this group, after performing the pre-test the patients will be receive music therapy and aerobic exercise, according to the protocol of two other intervention groups that explained. In this method, aerobic exercise will be perform in the morning and music therapy will be perform in the evening. At the end of the interventions the post-test will be perform. Intervention 4: Control group: without training.</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 There are not more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Milad Bazazorde</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Education &amp; Psychology, University of Mohaqeq Ardabili, University street, Ardabil</address>
        <city>Ardabil</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5451917961</zip>
        <telephone>+98 45 3551 2081</telephone>
        <email>milad_bazazorde@yahoo.com</email>
        <affiliation>The University of Mohaghegh Ardabili</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Milad Bazazorde</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Education &amp; Psychology, University of Mohaqeq Ardabili, University street, Ardabil</address>
        <city>Ardabil</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5451917961</zip>
        <telephone>+98 45 3551 2081</telephone>
        <email>milad_bazazorde@yahoo.com</email>
        <affiliation>The University of Mohaghegh Ardabili</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>a diagnosis of schizophrenia by a psychiatrist based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-V)
age18–65 years</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>changes in medication during the intervention
medical contraindication for physical activity</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F20</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Schizophrenia</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Music therapy. Before performing music therapy, the pre-test will be perform. Music therapy will hold in 8 sessions for four weeks (twice a week). Each session last 60 min. This intervention comprise of passive music interventions including music listening. The music use in this study include eight light music that play with an mp3 player attach to a speaker. During the intervention, the participants  should not draw or image to the music, but they will allow to talk about that after finishing the session. Patients will ask to concentrate on the music to become relaxed and lie in a bed or chair in comfortable position during the music therapy sessions. After performing music therapy, the post-test will be perform.</i_keyword>
      <i_keyword>Intervention group: Aerobic exercise. Before performing the aerobic exercises, the pre-test will be perform. The aerobic exercise program consisted of eight exercise sessions over the course of four weeks. Each session of the aerobic exercise involve stretching the large muscle groups as a warm-up (10 min), performing the aerobic exercise during the main phase (40 min), and stretching the center-based muscle during a cool-down stage (10 min). After performing aerobic exercises, the post-test will be perform.</i_keyword>
      <i_keyword>Intervention group: Music therapy with aerobic exercise. In this group, after performing the pre-test the patients will be receive music therapy and aerobic exercise, according to the protocol of two other intervention groups that explained. In this method, aerobic exercise will be perform in the morning and music therapy will be perform in the evening. At the end of the interventions the post-test will be perform.</i_keyword>
      <i_keyword>Control group: without training</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Positive and negative symptoms. Timepoint: Before the intervention and 1 week after the intervention. Method of measurement: Positive and Negative syndrome scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of sleep. Timepoint: Before the intervention and 1 week after the intervention. Method of measurement: Pittsburgh Sleep Quality Index.</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>ْThe University of Mohaqeq Ardabili</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-03-10</approval_date>
        <contact_name>Ethics committee of Ardabil University of Medical Scienses</contact_name>
        <contact_address>Daneshgah Ave. Ardabil Ardabil Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
