<?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>IRCT2012081510606N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-10-08</date_registration>
      <primary_sponsor>Deputy of Research, Faculty of Nursing and Midwifery, Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Effect of music therapy on preterm infants</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Classical Music and Lullaby on Physiologic Parameters and Sleep/Awake State of Hospitalized Preterm Infants in NICU</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-03-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/11078</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>physiologic parameters and sleep/awake status.</hc_freetext>
      <i_freetext>Intervention 1: This study is crossover and every sample is observed one time as control and two anothrt times as intervention groups. every situation lasts for two days. intervention situations  include lullaby and classical music and for every situation two days. observaton time in all situations is 40min every day.it starts 10min before music in intervention groups and continues for 20min music time and 10min after music. &#13;
in lullaby situation,0.5 to 1 hr after nutrition we start observation.2 cameras record dependent variables.10 min after start, lullaby is played through 2 speakers, located at incubater corners,with 30 cm of infant's head, in 45-50 dl for 20 min.observation lasts 20 min after music..this situation for every infant includs 2 consecutive days. Intervention 2: in classical music  situation,0.5 to 1 hr after nutrition we start observation.2 cameras record dependent variables.10 min after start, classical music(Baby Mozzart) is played through 2 speakers, located at incubater corners,with 30 cm of infant's head, in 45-50 dl for 20 min.observation lasts 20 min after music. this situation for every infant includs 2 consecutive days. Intervention 3: in control situation.every infant is observed 40 min,start 0/5 to 1 hr after nutrition.2 cameras record dependent variables.this situation for every infant includs 2 consecutive days.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Prisa Rafiei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, Tehran University of Medical Sciences , Tohid sq.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6693 7120</telephone>
        <email>rafie_p@razi.tums.ac.ir</email>
        <affiliation>Faculty of Nursing and Midwifery, Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Elaheh Amini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Valiasr center, Emam Khomeini hospital, Dr Gharib st, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6119 2359</telephone>
        <email>amini_el88@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: 1) infant GA in birth between 27w and 6d  and 37w and 0d,  2)no congenital abnormality, no heart or neurologic disease, 3) intact hearing,4)no opiate, sedative or anticonvulsive therapy.&#13;
Exclusion criteria: 1) all situation causes need for oxygen therapy or respiratory support, 2) increased infant distress or hypersensivity to intervention, 3) discharge, 4) parents refuse to continue.</inclusion_criteria>
      <agemin>28 years</agemin>
      <agemax>37 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>XVI</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Certain conditions originating in the perinatal period</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>This study is crossover and every sample is observed one time as control and two anothrt times as intervention groups. every situation lasts for two days. intervention situations  include lullaby and classical music and for every situation two days. observaton time in all situations is 40min every day.it starts 10min before music in intervention groups and continues for 20min music time and 10min after music. &#13;
in lullaby situation,0.5 to 1 hr after nutrition we start observation.2 cameras record dependent variables.10 min after start, lullaby is played through 2 speakers, located at incubater corners,with 30 cm of infant's head, in 45-50 dl for 20 min.observation lasts 20 min after music..this situation for every infant includs 2 consecutive days.</i_keyword>
      <i_keyword>in classical music  situation,0.5 to 1 hr after nutrition we start observation.2 cameras record dependent variables.10 min after start, classical music(Baby Mozzart) is played through 2 speakers, located at incubater corners,with 30 cm of infant's head, in 45-50 dl for 20 min.observation lasts 20 min after music. this situation for every infant includs 2 consecutive days.</i_keyword>
      <i_keyword>in control situation.every infant is observed 40 min,start 0/5 to 1 hr after nutrition.2 cameras record dependent variables.this situation for every infant includs 2 consecutive days.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Respiration rate. Timepoint: every 2 min, for before, simultaneous and after intervention periods. Method of measurement: respiration rate in 1 min,with observation.</prim_outcome>
      <prim_outcome>Blood pressure. Timepoint: every 5 min for before, simultaneous and after intervention periods. Method of measurement: with osilometric method and  bedside monitoring based on mmhg.</prim_outcome>
      <prim_outcome>Heart rate. Timepoint: every 2 min for before, simultaneous and after intervention periods. Method of measurement: with bedside monitoring.</prim_outcome>
      <prim_outcome>O2saturation. Timepoint: every 2 min for before, simultaneous and after intervention periods. Method of measurement: based on saturated Hb percentile, with pulseoximeter.</prim_outcome>
      <prim_outcome>Sleep/awake status. Timepoint: every 2 min for before, simultaneous and after intervention periods. Method of measurement: includ 6 stages based on Brazelton sleep/awake statuses.</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>Deputy of Research, Faculty of Nursing and Midwifery, Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2011-08-20</approval_date>
        <contact_name>Tehran Universty of Medical Sciences Ethics Committee</contact_name>
        <contact_address>Tehran, Keshavarz blv, Ghods st. Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
