<?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>IRCT2016012626217N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-03-09</date_registration>
      <primary_sponsor>Vice Chancellor for research, Iran University Of Medical Science</primary_sponsor>
      <public_title>The effects of Cold therapy and Music therapy in pain chest tube removal</public_title>
      <acronym></acronym>
      <scientific_title>Synergic effect of Cold therapy and Music therapy on pain of removing chest tube in heart bypass surgery patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-03-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>180</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/21776</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Other design features: Randomization will achieve with using sample block method.</study_design>
      <phase>2</phase>
      <hc_freetext>Coronary and valvular heart surgery.</hc_freetext>
      <i_freetext>Intervention 1: In cold therapy group, ice pack with temperature -5 °C will place in contact with the patient's skin for 20 minutes and chest tube will be removed after a maximum of two minutes after completion of cold therapy. The severity of patients pain in all study groups will measure before, during and 15 minutes after removal chest tube using a visual analog scale. Intervention 2: In music therapy group, a music from the list, which includes 15 tracks, are chosen by each patient and will play from 15 minutes before to 15 minutes after chest tube removal through headphone. The list includes local and traditional music and will play with maximum sound level of 60 decibel. The severity of patients pain in this  study groups will measure before, during and 15 minutes after removal chest tube using a visual analog scale. Intervention 3: In patients who use the combination of music therapy and cold therapy interventions will applied for the patients before removing chest tube. The severity of patients’ pain in this  study groups will measure before, during and 15 minutes after removal chest tube using a visual analog scale. Intervention 4: The control group will received routine nursing intervention for chest tube removal. The severity of patients’ pain in this  study groups will measure before, during and 15 minutes after removal chest tube using a visual analog scale.</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>Sajad Yarahmadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 43, Alleys Yasmane 11, Thirty yards street, Vali Asr street</address>
        <city>Khorammabad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6816885916</zip>
        <telephone>+98 66 3322 5655</telephone>
        <email>yarahmadi.s@tak.iums.ac.ir</email>
        <affiliation>Iran University Of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nooredin Mohammadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rasheed Yasemi street, higher than Mirdamad, Vali Asr street, School of Nursing and Midwifery</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 4365 1000</telephone>
        <email>nooredin.mohammadi@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:&#13;
Minimum age of 18 and a maximum of 65 years؛ Having at least one a pleural chest tube for at least 24 hours؛ Absence of vision problems and be able to read a ruler؛ Have the ability to answer questions properly researcher؛ Absence of hearing loss؛ No history of mental disorder؛ Absence of addiction to drugs or alcohol؛ Body Mass Index less than30 Kilograms per square meter؛ No sedative medication one hour before chest tube removal؛ Self ventilation؛ Keenness to listen folk music.&#13;
Exclusion criteria:&#13;
Are having pain score higher than 7 before chest tube removal؛ Unwillingness to continue to participate in the study؛ Discomfort during cold therapy؛ Using narcotic medication or sedative during intervention.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I97.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other functional disturbances following cardiac surgery</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In cold therapy group, ice pack with temperature -5 °C will place in contact with the patient's skin for 20 minutes and chest tube will be removed after a maximum of two minutes after completion of cold therapy. The severity of patients pain in all study groups will measure before, during and 15 minutes after removal chest tube using a visual analog scale.</i_keyword>
      <i_keyword>In music therapy group, a music from the list, which includes 15 tracks, are chosen by each patient and will play from 15 minutes before to 15 minutes after chest tube removal through headphone. The list includes local and traditional music and will play with maximum sound level of 60 decibel. The severity of patients pain in this  study groups will measure before, during and 15 minutes after removal chest tube using a visual analog scale.</i_keyword>
      <i_keyword>In patients who use the combination of music therapy and cold therapy interventions will applied for the patients before removing chest tube. The severity of patients’ pain in this  study groups will measure before, during and 15 minutes after removal chest tube using a visual analog scale.</i_keyword>
      <i_keyword>The control group will received routine nursing intervention for chest tube removal. The severity of patients’ pain in this  study groups will measure before, during and 15 minutes after removal chest tube using a visual analog scale.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Amount of pain. Timepoint: Before،during the intervention and 15 minute after intervention. Method of measurement: visual analog 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>Vice Chancellor for research, Iran University Of Medical Science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-01-21</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Rasheed Yasemi street, higher than Mirdamad, Vali Asr street, School of Nursing and Midwifery Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
