<?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>IRCT20091219002889N11</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-01-07</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>Body Relaxation techniques and Pre-eclampsia Syndrome</public_title>
      <acronym></acronym>
      <scientific_title>The effect of relaxation technique on preeclampsia and its consequences in high risk pregnant mothers referred to Selected comprehensive Health centers of Isfahan</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>98</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53291</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: The initial selection of pregnancy records of pregnant women was done randomly based on a table of random numbers. Samples were randomly divided into experimental (even numbers) and control (unit numbers) groups.This numbering was done up to 100.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Preeclampsia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: the experimental group participated in 16 sessions(8 sessions in the class and 8 sessions at home) of 30-minute relaxation with the Jacobson and Benson methods.Thus, the first session was at 20 to 24 weeks of pregnancy. Next, at 24 to 34 weeks of pregnancy, there were five sessions every two weeks. Then, at 34 to 36 weeks of pregnancy, there were two sessions every a week. Mother blood pressure was recorded before and after each session using a microlife.digital device. Then each participant in the first session was given a CD and relaxation technique training. At the first 10 minutes of relaxation technique, the following actions were performed to physically relax. At first, the mother was in a relaxed position (Semi-prone position) and after concentration, deep breathing and abdominal breathing exercises were performed. BRT was performed with Jacobson's method of contraction (5 seconds) and then conscious muscle release (30 seconds) to consciously relieve muscle tension (14). Then, at the final 20 minutes, visualization and mind imagery were carried out (with Benson's method), which contained three fictional content and at each session, a story content was performed. As such, after three sessions, all three contents were performed. Intervention 2: Control group: underwent routine medical care and Participate in PLC, the blood pressure, the Dass21 Stress Questionnaire, urine protein were measured once in the entrance to the study in the same manner as the experimental group, and re-examined at 36 weeks of pregnancy. Only Banson's relaxation was performed for 10 minutes with completely different content without Jackson's relaxation and deep relaxation. for the control group, by Perform a kind of Benson relaxation, is considered as a placebo for Body Relaxation technique. After 36 weeks of pregnancy, the mothers were followed up weekly by telephone. Furthermore, the researcher was present at the hospital during delivery and the mother was evaluated for gestational age, maternal hypertension, and PES. Maternal PES was diagnosed based on the approval of a gynecologist.</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:
The end result of the data is anonymously shared.

When:
After being published in the magazine

To whom:
Researcher

Conditions:
Executors of research project

Where to obtain:
Ministry of Health, Deputy Minister of Education

How to obtain:
Data will be sent via email and data request and consultation with the implementers of this project.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahboubeh Valiani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezar Jerib Avenue, Isfahan University of Medical Sciences, Faculty of Nursing and Midwifery .</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3792 7538</telephone>
        <email>Valiani@nm.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahboubeh Valiani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezar Jerib Avenue, Isfahan University of Medical Sciences, Faculty of Nursing and Midwifery .</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 3792 7538</telephone>
        <email>Valiani@nm.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>pregnant mothers from 20-24 weeks of gestation,
literacy,
first or second pregnancy,
PES background in previous pregnancy or chronic hypertension in previous pregnancy,
lack of smoking, alcohol and psychotropic substances using history,
high proteinuria up to Trace level, blood pressure less than 140/90 mm Hg,
no psychiatric disorders and severe anxiety (person who scored above 26 on DASS21 questionnaire),
having CD player, a computer or an Android mobile phone in order to listen to the audio of relaxation file at home.
Age range 16 to 43 years</inclusion_criteria>
      <agemin>16 years</agemin>
      <agemax>43 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Stress score obtained from the questionnaire is more than 26
Proteinuria over trace
Blood pressure over than 140/90</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O10.412</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pre-existing secondary hypertension complicating pregnancy, second trimester</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: the experimental group participated in 16 sessions(8 sessions in the class and 8 sessions at home) of 30-minute relaxation with the Jacobson and Benson methods.Thus, the first session was at 20 to 24 weeks of pregnancy. Next, at 24 to 34 weeks of pregnancy, there were five sessions every two weeks. Then, at 34 to 36 weeks of pregnancy, there were two sessions every a week. Mother blood pressure was recorded before and after each session using a microlife.digital device. Then each participant in the first session was given a CD and relaxation technique training. At the first 10 minutes of relaxation technique, the following actions were performed to physically relax. At first, the mother was in a relaxed position (Semi-prone position) and after concentration, deep breathing and abdominal breathing exercises were performed. BRT was performed with Jacobson's method of contraction (5 seconds) and then conscious muscle release (30 seconds) to consciously relieve muscle tension (14). Then, at the final 20 minutes, visualization and mind imagery were carried out (with Benson's method), which contained three fictional content and at each session, a story content was performed. As such, after three sessions, all three contents were performed.</i_keyword>
      <i_keyword>Control group: underwent routine medical care and Participate in PLC, the blood pressure, the Dass21 Stress Questionnaire, urine protein were measured once in the entrance to the study in the same manner as the experimental group, and re-examined at 36 weeks of pregnancy. Only Banson's relaxation was performed for 10 minutes with completely different content without Jackson's relaxation and deep relaxation. for the control group, by Perform a kind of Benson relaxation, is considered as a placebo for Body Relaxation technique. After 36 weeks of pregnancy, the mothers were followed up weekly by telephone. Furthermore, the researcher was present at the hospital during delivery and the mother was evaluated for gestational age, maternal hypertension, and PES. Maternal PES was diagnosed based on the approval of a gynecologist.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Blood pressure. Timepoint: Blood pressure was measured and recorded before and after the intervention in experimental and control group from the beginning and 36 weeks of pregnancy. Method of measurement: Digital Blood Pressure Monitor.</prim_outcome>
      <prim_outcome>Stress score. Timepoint: stress score was measured and recorded before and after the intervention in experimental and control group from the beginning and 36 weeks of pregnancy. Method of measurement: Dass21 Questionnaire,.</prim_outcome>
      <prim_outcome>Infant weight. Timepoint: After delivery,  birth weight was measured and recorded. Method of measurement: scales.</prim_outcome>
      <prim_outcome>Gestational age. Timepoint: After delivery, gestational age was measured and recorded. Method of measurement: Gestational age based on LMP or the first sono of pregnancy.</prim_outcome>
      <prim_outcome>Proteinurine. Timepoint: proteinurine was measured and recorded before and after the intervention in experimental and control group from the beginning and 36 weeks of pregnancy. Method of measurement: Roshe Laboratory Kit.</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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-11-18</approval_date>
        <contact_name>Ethics committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Hezar Jerib Avenue, Isfahan University of Medical Sciences, Faculty of Nursing and Midwifery . Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
