<?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>IRCT20171209037795N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-07-22</date_registration>
      <primary_sponsor>Bojnourd University of Medical Sciences</primary_sponsor>
      <public_title>The effect of acupressure on the Non Stress Test results</public_title>
      <acronym>طب فشاری</acronym>
      <scientific_title>The Effect of Acupressure on Points (LV3) on Non Stress Test Results, Mother Heart Rate and Blood Pressure in Pregnant Mothers</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-03-08</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>84</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/32427</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Diagnostic, Other design features: The study has an intervention group that the researcher is doing non stress test on the mother a with pressure on  LV3 point , and is performed routinely in the control group, Randomization description: First, a non-objective sampling method of purposeful sampling will be conducted among women who are willing to participate and criteria for entering the research.Then, according to the random number table, randomization will be done for each random sample, based on the set point on the random numbers table and determining the direction to the right if the number was read from the paired table to the control group and if the person It was entered into the intervention group, Blinding description: After intervention in the intervention group and in the control group, after the test, NST  (Non stress test) is interpreted by a specialist in the hospital and then by a skilled and unaware person for study purposes.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Acupressure, LV3 point,fetus non stress test.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Mothers of the study will be asked to lie flat on the left side and after hearing of the heartbeat of the fetus and to ensure the absence of uterine contraction, stress-free test is performed for 20 minutes, after 5 minutes, in the intervention group, a researcher An equivalent of 3 kg will be given for 1 minute and rest for 30 seconds, and will be performed for a total of 2.5 minutes for each leg. Intervention 2: Control group: The researcher will only touch the point near the point LV3 (2 cm radius) that is not on Meridian's path.</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:
Total data

When:
A year after printing results

To whom:
Researchers working in academic institutions

Conditions:
Applying unidentifiable individual data

Where to obtain:
Email

How to obtain:
Email request, plan explanation, answer

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Bagheri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bentolhoda Haspital</address>
        <city>Bojnord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9415614963</zip>
        <telephone>+98 32414474</telephone>
        <email>bagherim@nkums.ac.ir</email>
        <affiliation>Bojnourd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maryam Bagheri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bentolhoda Haspital</address>
        <city>Bojnord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9415614963</zip>
        <telephone>+98 58 3241 4474</telephone>
        <email>bagherim@nkums.ac.ir</email>
        <affiliation>Bojnourd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>To participate in the research, you must be informed in writing.
Age 18 to 35 years old.
Have at least basic elementary education
Pregnancy was first and single.
The gestational age was 40  to 42 weeks.
There is no medical problem.
There is no maternity problem.
Do not consume drugs or alcohol.
No students or health care personnel.
During pregnancy, do not have severe mental or physical problems.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>If she had a contraction.
The  basic heart rate of the fetus is less than 110 beats per minute.
The  basic heart rate of the fetus is greater than 160 beats per minute
Maternal blood pressure is greater than or equal to 140 to 90 mmHg.
Mother's pulse is more than 100 beats per minute.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>P00-P96</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Certain conditions originating in the perinatal period</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Diagnosis</i_code>
      <i_code>Diagnosis</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Mothers of the study will be asked to lie flat on the left side and after hearing of the heartbeat of the fetus and to ensure the absence of uterine contraction, stress-free test is performed for 20 minutes, after 5 minutes, in the intervention group, a researcher An equivalent of 3 kg will be given for 1 minute and rest for 30 seconds, and will be performed for a total of 2.5 minutes for each leg.</i_keyword>
      <i_keyword>Control group: The researcher will only touch the point near the point LV3 (2 cm radius) that is not on Meridian's path.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fetal non stress test result,. Timepoint: Pulse measurement and maternal blood pressure 5 minutes before the test and 5 minutes after intervention. Method of measurement: Pulse count, mercury pressure gauge machine.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Mother's pulse and blood pressure. Timepoint: 5 minutes before and after intervention. Method of measurement: Pulse count and mercurial blood pressure device.</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>Bojnourd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-12-27</approval_date>
        <contact_name>Ethics Committee of North Khorasan University of Medical Sciences</contact_name>
        <contact_address>Bojnurd Bentolhoda haspital Bojnurd North Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
