<?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>IRCT20110524006582N39</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-02-12</date_registration>
      <primary_sponsor>Tabriz University of Medical Sciences</primary_sponsor>
      <public_title>Comparing the effect of acupressure and Rebozo technique on labor pain and experience</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of acupressure on SP6 point and Rebozo technique on labor pain and experience</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-04-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/74114</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: The participants were classified by the random block method based on receiving induction or not receiving induction, being nulliparous or multiparous, and the center of the sampling location with block sizes of 3 and 6 and with an allocation ratio of 1:1:1 to three. The group (first group: recipient of acupressure, second group: recipient of Rebozo technique and third group: control group) will be assigned. For Allocation Concealment, the type of intervention will be written on a sheet of paper by a person not involved in the study and placed inside opaque envelopes numbered from 1 to 90. The envelopes will be opened in the order in which the participants entered the study and the type of intervention received will be determined, Blinding description: This research is a single-blind randomized clinical trial. Only the data analyzer,outcom assessor and data safety monitoring border are unaware of the study groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Labor pain and childbirth experience.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Rebozo recipient group during the active phase (after cervical dilatation reaches 4 cm), while the patient is on his hands and knees or standing, Rebozo is placed around the abdomen or hips, and its ends are in the hands of the midwife (student researcher). - will be seen. Then the researcher will shake the shawl from one side to the other for 20 minutes using small movements. This work will be done with three repetitions in 4-5, 7-8 and 9-10 cm dilatations of the cervix. Intervention 2: Intervention group: The group receiving acupressure: During the active phase (after cervical dilatation reaches 4 cm), the researcher will apply direct and continuous pressure to the SP6 point with his index finger or thumb, so that when the participant is sitting or lying on the left side, the researcher will press the SP6 point or He will press the Sanyinjiao with his index finger or thumb directly and continuously for one minute. Then 20 to 30 minutes later, pressure will be applied on the opposite leg under the same conditions. This work will be done with three repetitions in 4-5, 7-8 and 9-10 cm dilatations of the cervix. Intervention 3: Control group: will receive routine labor care.</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 Participants data is confidential.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shaghayegh Aslani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Marand City, 3 Timuri Alley Station St</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>000000000</zip>
        <telephone>+98 41 4225 9791</telephone>
        <email>Shagayegaslani75@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahin Kamali Fard</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and Midwifery school, Shariati street</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9876598765</zip>
        <telephone>+98 41 3524 5181</telephone>
        <email>Kamalifardm@gmail.com</email>
        <affiliation>Tabriz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Healthy nullipar pregnant mothers
Gestational age of term
At the beginning of the active phase (4 cm dilatation)
Cephalic presentation of the fetus
Have a healthy amniotic sac
The presence of low-risk pregnancy without medical problems in pregnancy, including blood pressure, gestational diabetes, twin and multiple pregnancy, placenta and amniotic fluid disorders, etc.
A fetus with an estimated normal weight
Reluctance to receive a painless delivery except for Rebezo and acupressure (remifentanil, other pain relief methods such as massage, breathing, etc.)
No addiction to drugs and smoking</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Mothers with birth problems including pre-eclampsia, gestational diabetes, cholestasis, discharge and rupture of the amniotic sac, twin and multiple pregnancies, placenta and amniotic fluid disorders, etc.
A history of rapid delivery
History of chronic systemic, cardiac, pulmonary diseases according to the patient's self-report and medical records
Amniotic fluid meconium before intervention
The presence of any disorders and skin diseases and bone fractures in the place of acupressure and Rebozo technique</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>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Rebozo recipient group during the active phase (after cervical dilatation reaches 4 cm), while the patient is on his hands and knees or standing, Rebozo is placed around the abdomen or hips, and its ends are in the hands of the midwife (student researcher). - will be seen. Then the researcher will shake the shawl from one side to the other for 20 minutes using small movements. This work will be done with three repetitions in 4-5, 7-8 and 9-10 cm dilatations of the cervix.</i_keyword>
      <i_keyword>Intervention group: The group receiving acupressure: During the active phase (after cervical dilatation reaches 4 cm), the researcher will apply direct and continuous pressure to the SP6 point with his index finger or thumb, so that when the participant is sitting or lying on the left side, the researcher will press the SP6 point or He will press the Sanyinjiao with his index finger or thumb directly and continuously for one minute. Then 20 to 30 minutes later, pressure will be applied on the opposite leg under the same conditions. This work will be done with three repetitions in 4-5, 7-8 and 9-10 cm dilatations of the cervix.</i_keyword>
      <i_keyword>Control group: will receive routine labor care.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Labor pain score. Timepoint: After the contraction at the beginning of the active phase and before the intervention, then it will be measured every one hour until reaching the second phase and one hour after the end of labor. Method of measurement: VAS listed line.</prim_outcome>
      <prim_outcome>Birth experience score. Timepoint: 12 to 24 hours after delivery. Method of measurement: Labor Agentry Scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Duration of labor stages. Timepoint: When the dilatation of the cervix reaches 4 cm, it will be recorded in the partograph form. Method of measurement: Partograph form.</sec_outcome>
      <sec_outcome>Score of satisfaction with childbirth. Timepoint: 12 to 24 hours after delivery. Method of measurement: (Mackey Satisfaction Rating Scale=MCSRS).</sec_outcome>
      <sec_outcome>Apgar score of the baby in the first and fifth minutes. Timepoint: The first and fifth minutes after the birth of the baby. Method of measurement: Baby's Apgar chart.</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>Tabriz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-01-01</approval_date>
        <contact_name>Ethics committeeof Tabriz University of Medical Sciences</contact_name>
        <contact_address>No2 central building,3rd floor,University street,Tabriz Univerrsity of medical sciences Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
