<?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>IRCT20180626040249N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-01-14</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Comparative study on the effect of massage and music on fatigue in mather,s of premature infant in neonatal intensive care unit</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of massage and music on the fatigue of mothers of premature infants admitted to the neonatal intensive care unit</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-07-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>41</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/32202</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Research units will be entered into the research according to the criteria for access to research. Random assignment will be done by blocking method. In this block A means (on the first day of the control phase and on the second day of music intervention and on the third day of massage intervention) and B will be done (on the first day of the control phase) On the second day of the massage, the massage will be performed on the third day of the music intervention). With each throw of dice and the arrival of a number on a dice, the rows of four moms are identified. If the number of dice 1 came in the sample as AABB, if 2 came ABAB, if 3 came BABA, if 4 came ABBA, if 5 came BAAB and if 6 came BBAA grouped.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Fatigue.</hc_freetext>
      <i_freetext>Intervention 1: Since the study design is cross-type, both groups receive the desired interventions in a different order. After the mothers are divided into two groups using block randomization method.                                             Group one: For the first group, baseline, music and massage are performed in three consecutive days (one intervention per day). At the control stage (the first day), the mothers first fill the fatigue questionnaire, then rest for 20 minutes on the bed and complete the fatigue questionnaire 15 minutes after the rest. At the music stage (the second day), the mothers first fill the fatigue questionnaire, then for 20 minutes, the sound of nature (the combination of the sounds of rain, river, waterfall and birds) is played out through the headphones for 20 minutes, and 15 minutes after the completion of the music, the fatigue questionnaire Mothers complete.It should be noted that the amount of sound is adjusted according to the mother and also, to prevent the transmission of infection (due to the use of headphones), after each use, headphones are disinfected.At the massage stage (third day), the mothers first fill the fatigue questionnaire. Then they were fitted with a comfortable and comfortable dressing on the bed. In order to create relaxation and massage, two methods of stroke massage (including percolation and stroke surface and deep) And Rolling.In the massage, the stroke of the palm of the hand is placed on the tissue in the organs and the back of the patient, and is applied to the lymphatic drainage path to a superficial and deep pressure without going into the bony mass points. In Rolling Massage, the muscle tissue is placed in rolls between the thumb and the mark in different places and moves. Rolling on the skin and muscles can affect relaxation.In the ringing massage, the muscle tissue between the thumb and the mark (between both hands) will move in opposite directions; each move will be three to five times, and the massage time will be 20 minutes. 15 minutes after completion of massage, the fatigue questionnaire was completed again by the mothers. Intervention 2: Group 2: For the second group, the steps of control, massage and music are performed in three consecutive days (one intervention per day).At the control stage (the first day), the mothers first fill the fatigue questionnaire, then rest for 20 minutes on the bed and complete the fatigue questionnaire 15 minutes after the rest.At the massage stage (tht second day), the mothers first fill the fatigue questionnaire. Then they were fitted with a comfortable and comfortable dressing on the bed. In order to create relaxation and massage, two methods of stroke massage (including percolation and stroke surface and deep) And Rolling.In the massage, the stroke of the palm of the hand is placed on the tissue in the organs and the back of the patient, and is applied to the lymphatic drainage path to a superficial and deep pressure without going into the bony mass points. In Rolling Massage, the muscle tissue is placed in rolls between the thumb and the mark in different places and moves. Rolling on the skin and muscles can affect relaxation.In the ringing massage, the muscle tissue between the thumb and the mark (between both hands) will move in opposite directions; each move will be three to five times, and the massage time will be 20 minutes. 15 minutes after completion of massage, the fatigue questionnaire was completed again by the mothers.At the music stage (third day), the mothers first fill the fatigue questionnaire, then for 20 minutes, the sound of nature (the combination of the sounds of rain, river, waterfall and birds) is played out through the headphones for 20 minutes, and 15 minutes after the completion of the music, the fatigue questionnaire Mothers complete.It should be noted that the amount of sound is adjusted according to the mother and also, to prevent the transmission of infection (due to the use of headphones), after each use, headphones are disinfected.</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 No more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Leila Abadian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tavid Square, Dr Mirkhani St. (Eastern Nusrat)</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6692 7171</telephone>
        <email>leyla.abadian95@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Batuol Pur Aboli Sharaf Abadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tavid Square, Dr Mirkhani St. (Eastern Nusrat)</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6105 4411</telephone>
        <email>b_pouraboli@sina.tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having a newborn admitted to the Neonatal Care Unit
Mother's presence for three consecutive days</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Not having a pregnancy history of a premature baby
Not having hearing problems based on mothers' statements
Not having chronic diseases like cardiovascular disease, cancers, nervous and muscular disorders
Not having an infective wound on the site of massage</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Since the study design is cross-type, both groups receive the desired interventions in a different order. After the mothers are divided into two groups using block randomization method.                                             Group one: For the first group, baseline, music and massage are performed in three consecutive days (one intervention per day). At the control stage (the first day), the mothers first fill the fatigue questionnaire, then rest for 20 minutes on the bed and complete the fatigue questionnaire 15 minutes after the rest. At the music stage (the second day), the mothers first fill the fatigue questionnaire, then for 20 minutes, the sound of nature (the combination of the sounds of rain, river, waterfall and birds) is played out through the headphones for 20 minutes, and 15 minutes after the completion of the music, the fatigue questionnaire Mothers complete.It should be noted that the amount of sound is adjusted according to the mother and also, to prevent the transmission of infection (due to the use of headphones), after each use, headphones are disinfected.At the massage stage (third day), the mothers first fill the fatigue questionnaire. Then they were fitted with a comfortable and comfortable dressing on the bed. In order to create relaxation and massage, two methods of stroke massage (including percolation and stroke surface and deep) And Rolling.In the massage, the stroke of the palm of the hand is placed on the tissue in the organs and the back of the patient, and is applied to the lymphatic drainage path to a superficial and deep pressure without going into the bony mass points. In Rolling Massage, the muscle tissue is placed in rolls between the thumb and the mark in different places and moves. Rolling on the skin and muscles can affect relaxation.In the ringing massage, the muscle tissue between the thumb and the mark (between both hands) will move in opposite directions; each move will be three to five times, and the massage time will be 20 minutes. 15 minutes after completion of massage, the fatigue questionnaire was completed again by the mothers.</i_keyword>
      <i_keyword>Group 2: For the second group, the steps of control, massage and music are performed in three consecutive days (one intervention per day).At the control stage (the first day), the mothers first fill the fatigue questionnaire, then rest for 20 minutes on the bed and complete the fatigue questionnaire 15 minutes after the rest.At the massage stage (tht second day), the mothers first fill the fatigue questionnaire. Then they were fitted with a comfortable and comfortable dressing on the bed. In order to create relaxation and massage, two methods of stroke massage (including percolation and stroke surface and deep) And Rolling.In the massage, the stroke of the palm of the hand is placed on the tissue in the organs and the back of the patient, and is applied to the lymphatic drainage path to a superficial and deep pressure without going into the bony mass points. In Rolling Massage, the muscle tissue is placed in rolls between the thumb and the mark in different places and moves. Rolling on the skin and muscles can affect relaxation.In the ringing massage, the muscle tissue between the thumb and the mark (between both hands) will move in opposite directions; each move will be three to five times, and the massage time will be 20 minutes. 15 minutes after completion of massage, the fatigue questionnaire was completed again by the mothers.At the music stage (third day), the mothers first fill the fatigue questionnaire, then for 20 minutes, the sound of nature (the combination of the sounds of rain, river, waterfall and birds) is played out through the headphones for 20 minutes, and 15 minutes after the completion of the music, the fatigue questionnaire Mothers complete.It should be noted that the amount of sound is adjusted according to the mother and also, to prevent the transmission of infection (due to the use of headphones), after each use, headphones are disinfected.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fatigue score in multi-dimensional fatigue  Inventory. Timepoint: 15 minutes before the intervention and 15 minutes after intervention, massage and music and control. Method of measurement: To measure fatigue, mothers are asked to use the Multidimensional Fatigue Inventory (MFI). This questionnaire, by assessing 5 dimensions, provides a deeper and more accurate understanding of the person's fatigue. In the MFI fatigue questionnaire, the fatigue of individuals is also measured in the physical dimension in the psychological dimension. For this reason, this questionnaire is preferred to other existing fatigue questionnaires. This tool has 20 questions and it has 5 areas: general fatigue (4 items), physical exhaustion (4 items), mental fatigue (4 items), activity fatigue (4 items), and motivation decrease (4 items).</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>medical University Tehran</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-06-13</approval_date>
        <contact_name>Ethics committee of Nursing and Midwifery &amp; Rehabilitation _ Tehran University of Medical Science.</contact_name>
        <contact_address>Tohid Square, Dr Mirkhani Avenue (Eastern Nusrat) Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
