<?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>IRCT20180108038265N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-10-08</date_registration>
      <primary_sponsor>Shahroud University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the impact of educate mothers, auriculotherapy on mothers and infant's massage by mothers on mother's anxiety symptoms in preterm labour</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the impact of educate mothers, auriculotherapy on mothers and infant's massage by mothers on mother's anxiety symptoms in preterm labour</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-10-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>96</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/33982</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: At first, the blocks are set to eight, they are divided into intervention and control groups according to the design blocks. The random allocation sequence is determined by the statistics expert by the software. The intervener puts each assignment in a white sealed envelope and numbers them. Eligible applicants will be registered by the intervener in order of entry into the study and receive the code. Before receiving the intervention, the basic questionnaires are filled in. Then for each individual, according to his code, an envelope is opened and the person to be assigned to the specified group, Blinding description: In this study, the mothers participating in the study, the person who assesses the outcomes, and Statistics Consultant are blind to the intervention and control groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Mother's anxiety.</hc_freetext>
      <i_freetext>Intervention 1: First Intervention group: is the mothers' education group. In this group, the mothers are related to the cause of the newborn's condition, strategies for coping with the infection, how to change the position of the premature baby, how to breast feed through breast or ng tube, maintaining the temperature, how to feed and keep milk, how to bathe And changing the nappies, disinfecting hands, and the like in the earliest possible time after the baby is admitted to the NICU, and become steady in the condition of the mother and the baby. Data were collected at two periods of time, 24 hours after admission to the NICU, before the start of the training session (as a preliminary test), second time (post test 1) after the intervention, and the third load (post test 2), at the time of discharge of the infant The intensive care unit will be assessed and compared using the relevant tool. Intervention 2: second Intervention group:The mother's massage group is the mother. Massage therapy will begin at the first time after the admission of a newborn in NICU and the condition of the baby will be physically and physically and mentally prepared for the baby, and will continue for 5 consecutive days and every 5 minutes. The first massage is done one hour after the morning feeding, the second half hour after the middle day and the third time 45 minutes after the second turn is completed. Each massage session will include 5 minutes of stimulation. To massage the baby into the abdomen (prone mode).The mother will warm her hands and be quiet and quiet during the work. Massage is done slowly and with the soles of the fingers. Massage is divided into five sections of one minute and each section divided into six episodes of ten seconds. The first part involves massage from the top of the head to the back of the neck and again from the back of the neck to the top of the head. Part II and III massage from the back of the neck to the shoulders and from the shoulders to the back of the neck. Part IV, massage from the back of the shoulders to the buttocks and back from the buttocks to the shoulders, but the contact with the beads is avoided.The fifth part involves simultaneous massage in two legs from the pelvic floor to the sole of the foot and backward from the bottom up. The sixth part involves both hands simultaneously from the shoulders to the wrists and back to the top. In fact, the steps of each massage cycle take five minutes, including five times a one minute massage, 10 seconds of head and neck massage, 20 seconds of shoulder massage, 20 seconds of back massage and 10 seconds massage of both legs. Data were collected at two time intervals, the first time before the beginning of massage sessions (as pretest) and the second time (as posttest 1) after the end of massage sessions and for the third time at the time of discharge of the baby (as a post-test 2) The ICT will be compared and evaluated using the relevant tools. Intervention 3: Third Intervention group: is  acupressure (uriculotherapy) that takes place on the mother. The onset of intervention will be after the baby's and mother's status. The points used in both the left and right ears are symmetric and include the points of "Sunnan, muscle relaxation and tension point and anxiety point". The researcher, using a pointer, first intersperses these points in the right ear in circular motion, pressing for 60 seconds for each point (4 cycles for 4 minutes each). Then the same thing will be done in the other ear. This intervention will be carried out 12 times (twice a day). The data are measured at two time points, the first time before the intervention (as a pre test) and the second time (post test 1), after the intervention, and the third load (post test 2) at the time of discharge of the baby with the relevant tools. Intervention 4: Control group: The only group was to check the absence of interventions and compare them with intervention groups. For these mothers, after the completion of the sampling, the training sessions will be similar to group 1.</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 Considering the presence of professors and trainers in this research, after consulting with them and if other researchers and professors participate in this project, the final analysis file will be available to the public as a printed article.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Niloufar rabiee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>7 Tir Square, Shahroud university of medical scinces</address>
        <city>Shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>36147-73947</zip>
        <telephone>+98 23 3239 5054</telephone>
        <email>n.rabiee2016@gmail.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nahid Bolbol haghighi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>7 Tir Square. Shahroud university of medical sciences</address>
        <city>Shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>36147-73947</zip>
        <telephone>+98 23 3239 5054</telephone>
        <email>nbhaghighi349@yahoo.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Mothers' satisfaction and cooperation to participate in research
Ability to speak Persian and have reading and writing skills
Age 18 to 35 years old
The infant is in the range of 28 weeks to 36 weeks.
There is the possibility of breastfeeding from the breast or ng tube</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Having a specific mental or physical illness or problem that requires the involvement of a third person in the care of the baby
Newborn sickness and maternal cessation of care
Infant death
Mother's dissatisfaction with continued caring</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>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>First Intervention group: is the mothers' education group. In this group, the mothers are related to the cause of the newborn's condition, strategies for coping with the infection, how to change the position of the premature baby, how to breast feed through breast or ng tube, maintaining the temperature, how to feed and keep milk, how to bathe And changing the nappies, disinfecting hands, and the like in the earliest possible time after the baby is admitted to the NICU, and become steady in the condition of the mother and the baby. Data were collected at two periods of time, 24 hours after admission to the NICU, before the start of the training session (as a preliminary test), second time (post test 1) after the intervention, and the third load (post test 2), at the time of discharge of the infant The intensive care unit will be assessed and compared using the relevant tool.</i_keyword>
      <i_keyword>second Intervention group:The mother's massage group is the mother. Massage therapy will begin at the first time after the admission of a newborn in NICU and the condition of the baby will be physically and physically and mentally prepared for the baby, and will continue for 5 consecutive days and every 5 minutes. The first massage is done one hour after the morning feeding, the second half hour after the middle day and the third time 45 minutes after the second turn is completed. Each massage session will include 5 minutes of stimulation. To massage the baby into the abdomen (prone mode).The mother will warm her hands and be quiet and quiet during the work. Massage is done slowly and with the soles of the fingers. Massage is divided into five sections of one minute and each section divided into six episodes of ten seconds. The first part involves massage from the top of the head to the back of the neck and again from the back of the neck to the top of the head. Part II and III massage from the back of the neck to the shoulders and from the shoulders to the back of the neck. Part IV, massage from the back of the shoulders to the buttocks and back from the buttocks to the shoulders, but the contact with the beads is avoided.The fifth part involves simultaneous massage in two legs from the pelvic floor to the sole of the foot and backward from the bottom up. The sixth part involves both hands simultaneously from the shoulders to the wrists and back to the top. In fact, the steps of each massage cycle take five minutes, including five times a one minute massage, 10 seconds of head and neck massage, 20 seconds of shoulder massage, 20 seconds of back massage and 10 seconds massage of both legs. Data were collected at two time intervals, the first time before the beginning of massage sessions (as pretest) and the second time (as posttest 1) after the end of massage sessions and for the third time at the time of discharge of the baby (as a post-test 2) The ICT will be compared and evaluated using the relevant tools.</i_keyword>
      <i_keyword>Third Intervention group: is  acupressure (uriculotherapy) that takes place on the mother. The onset of intervention will be after the baby's and mother's status. The points used in both the left and right ears are symmetric and include the points of "Sunnan, muscle relaxation and tension point and anxiety point". The researcher, using a pointer, first intersperses these points in the right ear in circular motion, pressing for 60 seconds for each point (4 cycles for 4 minutes each). Then the same thing will be done in the other ear. This intervention will be carried out 12 times (twice a day). The data are measured at two time points, the first time before the intervention (as a pre test) and the second time (post test 1), after the intervention, and the third load (post test 2) at the time of discharge of the baby with the relevant tools.</i_keyword>
      <i_keyword>Control group: The only group was to check the absence of interventions and compare them with intervention groups. For these mothers, after the completion of the sampling, the training sessions will be similar to group 1.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Mother's anxiety. Timepoint: Before intervention, immediately after the intervention and before discharge from the NICU. Method of measurement: This result will be measured using the standard, valid and reliable  questionnaire of Spilberger's apparent and hidden anxiety, which includes 20 questions about apparent anxiety and 20 questions about hidden anxiety that questions with Likert scale rating with very few options, Low, high and very high scores. Each of the options in the direct statements are in the order of points 1 to 4 and in reverse expressions, respectively, are points 4 to 1. The total score of the questionnaire is between 20 and 80.</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>Shahroud University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-08-28</approval_date>
        <contact_name>Ethics committee of Shahroud University of Medical Sciences</contact_name>
        <contact_address>7 Tir Square, Shahroud Shahroud Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
