<?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>IRCT20191207045635N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-02-02</date_registration>
      <primary_sponsor>Mashhad School of Nursing and Midwifery</primary_sponsor>
      <public_title>Comparison of the effect of Jacopsen's relaxed body and foot reflexology on    breastfeeding adequacy and breast milk volume in premature infants</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of Jacopsen's relaxed body and foot reflexology on    breastfeeding adequacy and breast milk volume in premature infants</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-02-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50226</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Randomization description: They will be invited to the study by available sampling and will be randomly divided into two groups of foot reflexology intervention and Jacopsen relaxation without replacement. A simple random selection of one of the groups and sampling will begin.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Fetus and newborn affected by other maternal noxious influences..</hc_freetext>
      <i_freetext>Intervention 1: The first intervention group of foot reflexology: which includes the preparation and warm-up steps and stimulation and massage techniques that will be performed by the researcher once a day for nine days in the rest room of mothers in the nicu ward of Ghaem Hospital. The entire floor and back surface. The foot is massaged for one minute, then the reflex areas of the breast and the solar plexus are pressed and rubbed for 5 minutes for each foot (the intensity of the pressure should be such that it feels numb in position). Mothers are taught how to perform reflexology by a researcher.Milk volume will be measured in the first days (once), third and ninth of the intervention. The volume of the milk will be measured one hour after the end of breastfeeding and two hours after the intervention by the Philips electric milking machine using a graduated scale by the researcher in two groups. The adequacy of breastfeeding in the two groups of mothers on the first day and twenty-one days later at the time of the mother's visit to examine the baby will be assessed by a questionnaire. Intervention 2: The second intervention group will experience Jacobs relaxation in nine days in the rest room of mothers in the neonatal ward of Ghaem Hospital by the researcher. In the Jacobsen relaxation group, the mother was first taught the practical technique. Jacobson was practically performed for 35 to 45 minutes by the researcher for the mother. It will be in the form of contracting separate muscles for 5 seconds and then relaxing the muscles for 10 seconds. These movements start first from the muscles of the head, face and neck regularly and in The middle and lower extremities of the body include the contraction of the muscles of the lower back, serine, thighs, legs, and toes.Milk volume will be measured in the first days (once), third and ninth of the intervention. The volume of the milk will be measured one hour after the end of breastfeeding and two hours after the intervention by the Philips electric milking machine using a graduated scale by the researcher in two groups. The adequacy of breastfeeding in the two groups of mothers on the first day and twenty-one days later at the time of the mother's visit to examine the baby will be assessed by a questionnaire.</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 reading the information about the main outcome.

When:
10 months after printing

To whom:
All researchers can apply for it.

Conditions:
Data and results for all researchers and for research purposes
The context of diabetes will be available.

Where to obtain:
SadeghiT@mums.ac.ir

How to obtain:
The data will be available to the applicant within one month after reviewing and confirming the application
Will be located.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Tahereh Sadeghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mashhad School of Nursing and Midwifery, Doctora intersection</address>
        <city>mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>91778-99191</zip>
        <telephone>+98 51 3841 2081</telephone>
        <email>sadeghit@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Tahereh Sadeghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Ibn Sina Street, Doctora intersection</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3859 1512</telephone>
        <email>SadeghiT@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The age of the mother is between at least 20 and at most 35 years old
Be literate, be able to understand writing and verbal instructions, express verbal anxiety.
The mother tends to breastfeed
The mother has no history of serious or chronic illness, such as cardiovascular disease or mental illness (postpartum depression, schizophrenia, according to the mother), according to the mother.
The mother is not addicted to smoking and drugs, especially cocaine and derivatives, as the mother says.
The mother does not take drugs that are contraindicated during breastfeeding, such as doxepin tricyclic antidepressants, iodine compounds, gold salts, salicylates, and anticonvulsants during the intervention.
The mother has no history of breast surgery and no history of injury or wound at the site of reflexology and no breast problems (fissures, congestion, mastitis and breast abscess).
The mother should not take lactation-enhancing drugs, including metoclopramide.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>The mother's unwillingness to continue participating in the research
Incidence of disease in the mother during the study.
Taking drugs that increase breast milk, such as metoclopramide.
Neonatal intubation need, vital signs disorder, bleeding, IVH grade 4, long-term NPO of the infant during the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>P04.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Newborn (suspected to be) affected by other maternal conditions noxious substances</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The first intervention group of foot reflexology: which includes the preparation and warm-up steps and stimulation and massage techniques that will be performed by the researcher once a day for nine days in the rest room of mothers in the nicu ward of Ghaem Hospital. The entire floor and back surface. The foot is massaged for one minute, then the reflex areas of the breast and the solar plexus are pressed and rubbed for 5 minutes for each foot (the intensity of the pressure should be such that it feels numb in position). Mothers are taught how to perform reflexology by a researcher.Milk volume will be measured in the first days (once), third and ninth of the intervention. The volume of the milk will be measured one hour after the end of breastfeeding and two hours after the intervention by the Philips electric milking machine using a graduated scale by the researcher in two groups. The adequacy of breastfeeding in the two groups of mothers on the first day and twenty-one days later at the time of the mother's visit to examine the baby will be assessed by a questionnaire.</i_keyword>
      <i_keyword>The second intervention group will experience Jacobs relaxation in nine days in the rest room of mothers in the neonatal ward of Ghaem Hospital by the researcher. In the Jacobsen relaxation group, the mother was first taught the practical technique. Jacobson was practically performed for 35 to 45 minutes by the researcher for the mother. It will be in the form of contracting separate muscles for 5 seconds and then relaxing the muscles for 10 seconds. These movements start first from the muscles of the head, face and neck regularly and in The middle and lower extremities of the body include the contraction of the muscles of the lower back, serine, thighs, legs, and toes.Milk volume will be measured in the first days (once), third and ninth of the intervention. The volume of the milk will be measured one hour after the end of breastfeeding and two hours after the intervention by the Philips electric milking machine using a graduated scale by the researcher in two groups. The adequacy of breastfeeding in the two groups of mothers on the first day and twenty-one days later at the time of the mother's visit to examine the baby will be assessed by a questionnaire.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Breastfeeding adequacy score in the breastfeeding questionnaire. Timepoint: Assess the adequacy of breastfeeding before the intervention and twenty-one days after the intervention. Method of measurement: Breastfeeding adequacy questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Volume of milk using a graduated scale one hour after the end of breastfeeding and two hours after the intervention. Timepoint: The volume of milk in the first days (once), third and ninth of the intervention will be measured one hour after the end of breastfeeding and two hours after the intervention by Philips electric milking machine using a calibrated scale by the researcher in two groups. Method of measurement: Breast milk will be milked using a Philips electric breast pump and milk volume will be measured using a calibrated gauge.</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>Mashhad School of Nursing and Midwifery</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-09-19</approval_date>
        <contact_name>Ethics Committee of Mashhad Collge of Nursing and Midwifery</contact_name>
        <contact_address>Faculty of Nursing and Midwifery, Ibn Sina St., Daneshgah St. Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
