<?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>IRCT2016120819862N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-08-11</date_registration>
      <primary_sponsor>Kerman University Of Medical Sciences</primary_sponsor>
      <public_title>Massage therapy and music on  nausea and vomiting caused by  chemotherapy in children with cancer</public_title>
      <acronym></acronym>
      <scientific_title>Assessment the of  massage therapy and music on  nausea and vomiting caused by  chemotherapy in children with cancer admitted to oncology ward</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-02-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/17655</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Supportive, Other design features: In first time children are divided two groups:Massage and music therapy then achieved one intervention,data are  recorded for 24 hours.Then any intervention is done for  each groups .In first step massage group listen music and music group massage. At this stage, 24-hour findings of nausea and vomiting will be recorded.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Neplasm.</hc_freetext>
      <i_freetext>In the first stage, children are divided into two groups, massage and music, that each group achieves one intervention. Data records for 24  hours. Then, in order to eliminate the effect of intervention in the next session, no intervention is required (period of clearing). In the second phase, the group who received the first massage will receive a music session at the same time, and. At this stage, 24-hour findings of nausea and vomiting will be recorded. The massage used in this study is Swedish massage, which includes rubbing movements, soft, long and light stroke, rhythmic stroke, and impulse in superficial muscle layers. Relaxation massage is also combined with joints movements by stretching the muscles, they can relieve pain. Swedish massage includes two sections of energy and relaxation. The four general moves of Swedish massage are as follows: 1- Nosebleed: Soft and quiet movement for relaxation of the soft texture of the rubbing: pressing and rolling that follows the movements of the stomach 2- 3- Friction: deep and circular movements that cause the layer. The tissues are rubbed together, which ultimately leads to increased blood pressure and loss of tissue injuries.4-Short and short strokes with hands in the shape of the cup, also using the fingers and edges of the hands for massage 20 minutes and half an hour before the chemotherapy.  Music that will be used in this study will include a list of all types of music ready and recorded, and after consultation with the parents of the desired music of the child, selected by the researcher using hearing aids from the headphones and walkman. It starts at about 15 minutes before and in length chemotherapy..</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>Dr Sakineh Sabzevari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Campus of Medical University, Haftbagh Highway</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>76177</zip>
        <telephone>+98 34 3132 5219</telephone>
        <email>S_Sabzevari@kmu.ac.ir; sabzevariz@yahoo.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Sakineh Sabzevari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Campus of medical University, Haft Bagh Highway</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>76177</zip>
        <telephone>+98 34 3132 5219</telephone>
        <email>S_Sabzevari@kmu.ac.ir; sabzevariz@yahoo.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion Criteria: Children with neoplasm diagnosis and  7-15 years old; Has chemotherapy order; Achieve at least one dose of chemotherapy and experienced nausea and vomiting.&#13;
Exclusion criteria:Some side effects such as infection; Bleeding; Sepsis; DIC; Referred to other clinical centers; Death belong  the time  of this research.</inclusion_criteria>
      <agemin>6 years</agemin>
      <agemax>15 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C00-C97</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>نئوپلاسم بدخیم</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the first stage, children are divided into two groups, massage and music, that each group achieves one intervention. Data records for 24  hours. Then, in order to eliminate the effect of intervention in the next session, no intervention is required (period of clearing). In the second phase, the group who received the first massage will receive a music session at the same time, and. At this stage, 24-hour findings of nausea and vomiting will be recorded. The massage used in this study is Swedish massage, which includes rubbing movements, soft, long and light stroke, rhythmic stroke, and impulse in superficial muscle layers. Relaxation massage is also combined with joints movements by stretching the muscles, they can relieve pain. Swedish massage includes two sections of energy and relaxation. The four general moves of Swedish massage are as follows: 1- Nosebleed: Soft and quiet movement for relaxation of the soft texture of the rubbing: pressing and rolling that follows the movements of the stomach 2- 3- Friction: deep and circular movements that cause the layer. The tissues are rubbed together, which ultimately leads to increased blood pressure and loss of tissue injuries.4-Short and short strokes with hands in the shape of the cup, also using the fingers and edges of the hands for massage 20 minutes and half an hour before the chemotherapy.  Music that will be used in this study will include a list of all types of music ready and recorded, and after consultation with the parents of the desired music of the child, selected by the researcher using hearing aids from the headphones and walkman. It starts at about 15 minutes before and in length chemotherapy.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Nausea and vomiting. Timepoint: Before and after intervention. Method of measurement: Adapted Rhodes Index of Nausea and Vomiting for Child,VAS.</prim_outcome>
      <prim_outcome>Nausea and vomiting. Timepoint: Before and after intervention. Method of measurement: Visual Analog Scale and Adopted Rhodes index Of Nausea and vomiting.</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>Kerman University Of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-09-23</approval_date>
        <contact_name>Kerman University of Medical Sciences</contact_name>
        <contact_address>Vice chancellor for  reserch, Tahmasb abad four way Kerman  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
