<?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>IRCT20090405001788N19</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-04-08</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of massage by mothers on the baby's weight and perceived Self-efficacy of mothers who have low birth weight babies in neonatal intensive care unit</public_title>
      <acronym></acronym>
      <scientific_title>The effect of massage by mothers on the baby's weight and perceived Self-efficacy of mothers who have low birth weight babies in neonatal intensive care unit</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/28054</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Using random allocation, two hospitals in Ahvaz educational centers will be selected as intervention and control, then newborns with entry criteria will be studied.</study_design>
      <phase>3</phase>
      <hc_freetext>Premature infants.</hc_freetext>
      <i_freetext>Intervention 1: In order to evaluate the effect of massage on weight loss in low birthweight and self-efficacy of mothers, massage will be performed for 60 days. Sampling is done in randomized blocks and participants will be asked to fill out the informed consent form, then the mothers who will be satisfied with the participation in the study will be selected. Interviews include: a) Presenting a booklet And a training DVD that is provided by the Neonatal Health Department and the Ministry of Health and Medical Education, 2015, with the collaboration and participation of the Neonatal Health Department of the Ministry of Health and Medical Education (Massage of Infants and Infants). It should be noted that the way the massage steps are performed on the DVD will be explained by the researcher in a comprehensible language for mothers. B) Presentation of massage training for mothers; c) conducting 2 one-hour training sessions by the researcher; d) practicing a mother in the presence of a researcher on a simple neonatal model that is available for routine training at the nursing school. An occupational therapist, along with a researcher, will be available to massage and confirm the correct way of massage at all stages of massage. If the mother needs more sessions and more hours for massage training, these trainings will be continued by the researcher until a proper massage is completed. Performing good massage and ensuring that all mothers have the right impression of massage therapy will be controlled by the researcher and occupational therapist through the observation of the massage performed by the moms on the moth. In all phases of film play for massage therapy and practical massage practice, the researcher will be presenting more explanations and solving the problems and questions of mothers along with them. The researcher's contact number is also available to answer questions from mothers 24 hours a day. Massage from the head to the tip of the baby while the baby's body is uncovered or if it has only a cover. Each mother will massage her baby with olive oil for 15 minutes (used for all samples of a commercial type), the study will continue for 60 days. Intervention 2: In the control group, mothers and newborns will receive only the usual care of the department (these include: physician's examination, daily weighting of the baby, drug therapy, serum therapy, training on the correct breast feeding to mothers, controlling the absorption and excretion of the baby, training and follow up Vaccination, training for the discharge of the baby and assessment of the correct nutrition of the infant).</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
After Data coding In order to keep confidentiality of the participants in the research

When:
the end of sampling till six month after article publishing.

To whom:
ethical ,  reviewer and  editorial committees, researchers

Conditions:
systematic review and meta analysis or secondary analysis 
citation

Where to obtain:
Leili Borimnejad , borimnejad.l@iums.ac.ir

How to obtain:
After sending request by academic email, we will send them data files up to one week.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Leili Borimnejad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing &amp; Midwifery,  Rashid Yasemi St..</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1996713883</zip>
        <telephone>+98 21 4365 1708</telephone>
        <email>borimnejad.l@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Leili Borimnejad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing &amp; Midwifery,  Rashid Yasemi St.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1996713883</zip>
        <telephone>+98 21 4365 1708</telephone>
        <email>borimnejad.l@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Neonatal Criteria:
The baby is asked for a pregnancy.
The birth weight of the infant is 2499-1500 grams
The gestational age of the infants is between 30 and 36 (32) weeks.
The baby has no contagious skin disease and genetic and congenital anomalies.
The baby has constant clinical conditions.
The baby does not have an interventional treatment such as chest tube and surgery.
At least ten days in hospital.
Maternal Entry Criterion:
The presence of the mother with the baby on all the days prescribed for massage.
Mother of iran.
Mother has no contagious skin disease in her hands.
Pregnancy is your mother's will.
Mothers are not addicted to drugs and alcohol.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>60 days</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>P07.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other low birth weight newborn</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In order to evaluate the effect of massage on weight loss in low birthweight and self-efficacy of mothers, massage will be performed for 60 days. Sampling is done in randomized blocks and participants will be asked to fill out the informed consent form, then the mothers who will be satisfied with the participation in the study will be selected. Interviews include: a) Presenting a booklet And a training DVD that is provided by the Neonatal Health Department and the Ministry of Health and Medical Education, 2015, with the collaboration and participation of the Neonatal Health Department of the Ministry of Health and Medical Education (Massage of Infants and Infants). It should be noted that the way the massage steps are performed on the DVD will be explained by the researcher in a comprehensible language for mothers. B) Presentation of massage training for mothers; c) conducting 2 one-hour training sessions by the researcher; d) practicing a mother in the presence of a researcher on a simple neonatal model that is available for routine training at the nursing school. An occupational therapist, along with a researcher, will be available to massage and confirm the correct way of massage at all stages of massage. If the mother needs more sessions and more hours for massage training, these trainings will be continued by the researcher until a proper massage is completed. Performing good massage and ensuring that all mothers have the right impression of massage therapy will be controlled by the researcher and occupational therapist through the observation of the massage performed by the moms on the moth. In all phases of film play for massage therapy and practical massage practice, the researcher will be presenting more explanations and solving the problems and questions of mothers along with them. The researcher's contact number is also available to answer questions from mothers 24 hours a day. Massage from the head to the tip of the baby while the baby's body is uncovered or if it has only a cover. Each mother will massage her baby with olive oil for 15 minutes (used for all samples of a commercial type), the study will continue for 60 days.</i_keyword>
      <i_keyword>In the control group, mothers and newborns will receive only the usual care of the department (these include: physician's examination, daily weighting of the baby, drug therapy, serum therapy, training on the correct breast feeding to mothers, controlling the absorption and excretion of the baby, training and follow up Vaccination, training for the discharge of the baby and assessment of the correct nutrition of the infant).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Baby weight. Timepoint: Weight gain on days 3, 10 and 60. Method of measurement: Weight of newborns using the German Seca digital scale with a precision of 10 ± g.</prim_outcome>
      <prim_outcome>Self-efficacy of mothers with preterm infants. Timepoint: At the end of the 2nd month of the baby. Method of measurement: Farsi version of the Self-efficacy Questionnaire (PMP S-E) Barnes and Adamson-Macedo (2007) will use maternal self-efficacy measurements.</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 Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-12-26</approval_date>
        <contact_name>Ethics committee of Iran University of medical Seinces</contact_name>
        <contact_address>Hemmat Highway Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
