<?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>IRCT20180128038535N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-02-25</date_registration>
      <primary_sponsor>Saveh University of Medical Sciences</primary_sponsor>
      <public_title>Determination of the effect of Entonox gas and B  massage on the severity of labor pain</public_title>
      <acronym></acronym>
      <scientific_title>A comparative study on the effect of Enonox gas and B massage on the severity of labor pain in primiparous and multiple women.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>69</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/29459</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this research, simple sampling method with random allocation to groups was used.Women who met the criteria for entry into the research requirements and at the time of the study, due to labor pain, they were referred to the hospital and admitted, easily entered the study. For random assignment, 
among those who entered the study according to the criteria for entering the study, based on the randomasation, they fell into  one of the groups B massage, Entonox gas and usual care ( the cards were prepared and three numbers 1, 2 and 3, were written and placed inside the packets in an unspecified manner and research unit removed one of the envelopes, if there was a number 1 in the group of B massage, number 2 in the group of Entonox gas, number 3 in the group of usual care were placed.), Blinding description: Clinical care (interventionist)was unaware of the goals of the study and
    researcher did not know from the group assigned to the specimens.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Entonox gas: Entonox is a mixture of two gases of oxygen and nitrous oxide (N2O) and is prescribed to a pregnant woman via a mask.When she feels pain during contraction of uterus in the stages of labor, put a special mask on her face and from inside it takes a deep breath.The gas enter the lungs and then the brain and  affects pain centers that reduce feelings of pain. Condition 2: B massage: One of the types of massage. Massage of the bottom of the back and is in the form of B. During uterine contractions, the masseur is in a standing or kneeling position next to the mother and carries out massage.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Entonox gas group. Intervention 2: Intervention group: B massage group. Intervention 3: Control group: The usual care group.</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>Mehri Rezaie</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Headquarters building., Islamic Republic Ave</address>
        <city>Saveh</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3919676651</zip>
        <telephone>+98 86 4221 6184</telephone>
        <email>mehrangize_rezai@yahoo.com</email>
        <affiliation>Saveh University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mehri Rezaie</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Headquarters building., Islamic Republic Ave</address>
        <city>Saveh</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3919676651</zip>
        <telephone>+98 86422216184</telephone>
        <email>mehrangize_rezai@yahoo.com</email>
        <affiliation>Saveh University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Pregnant women aged between 18-35 years old
Women with first, second, third and fourth pregnancies
Gestational age between 37 to 41 weeks
Singletone pregnancy
Head of presentation(cephalic)
Women in dilatation 4-5 centimeter or more</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>High-risk pregnant women (presence of previous scars on the uterus and abdomen, diabetic women, preeclampsia and eclampsia, Polyhydramnious, Oligohydramnious, fetal death and etc.)
There are skin or lumbar problems in the lower back region in the massage group</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Entonox gas group</i_keyword>
      <i_keyword>Intervention group: B massage group</i_keyword>
      <i_keyword>Control group: The usual care group</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Severity of  pain in the active phase of the first stage and second stage of labor. Timepoint: Immediately before the intervention, 45, 90, 135, 180 and 225 minutes after intervention. Method of measurement: Visual analogue Scale of McGill Pain.</prim_outcome>
      <prim_outcome>Type of delivery. Timepoint: After intervention. Method of measurement: Observation.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Postpartum hemorrhage. Timepoint: After intervention in the third stage of labor. Method of measurement: Observation and estimation of bleeding based on the need for hemoglobin to be checked in the first 6 hours after delivery, blood transfusion, need for uterine massage or prescribe misoprostol.</sec_outcome>
      <sec_outcome>Apgar score of the infant in the first and fifth minutes of birth. Timepoint: After intervention and delivery. Method of measurement: Neonate Apgar Scale.</sec_outcome>
      <sec_outcome>The need for newborn resuscitation. Timepoint: After intervention and delivery. Method of measurement: Neonatal resuscitation according to national protocol.</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>Saveh University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-07-26</approval_date>
        <contact_name>Ethics committee of Saveh University of Medical Sciences</contact_name>
        <contact_address>Headquarters building., Islamic Republic Ave Saveh Markazi Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
