<?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>IRCT20220302054163N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-03-14</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>The effect of massage therapy, hydrotherapy and raised legs on foot edema in pregnancy by self-care method</public_title>
      <acronym></acronym>
      <scientific_title>A comparative study on the effects of a self-care educational program on the effleurage massage with foot immersion and raised legs on foot physiological edema during pregnancy.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>140</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/62272</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Supportive, Randomization description: the sample size for each of the intervention and control groups is staged. first, the choice of treatment centers, purposefully, and then the selection of intervention days are collected randomly from three different treatment centers separately. For each of the intervention groups, the sample size will be collected from a medical center and for the control group, 12 samples will be collected from each center.In the process of randomizing intervention days, Excel computer software, random numbers function will be used.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Physiological pitting edema in pregnancy.</hc_freetext>
      <i_freetext>Intervention groups: self care with effleurage massage,self care with hydrotherapy,selfe care with raised legs.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is The data remain confidential to the researcher at the beginning of the study</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Masoumeh Simbar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran, Valiasr St., Niayesh Intersection, in front of Shahid Rajaei Heart Hospital, Shahid Beheshti School of Nursing and Midwifery</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+098 21 88655356-7</telephone>
        <email>Msimbar@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Masoumeh Simbar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran, Valiasr St., Niayesh Intersection, in front of Shahid Rajaei Heart Hospital, Shahid Beheshti School of Nursing and Midwifery</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985717443</zip>
        <telephone>+98 21 88655366-7</telephone>
        <email>Msimbar@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1. Pregnancy is primiparous
2. The age range is 20 to 35 years
3. Be a single pregnancy
4. Pregnancy is not the result of ART
5. The gestational age is between 30 and 40 weeks
6. Has physiological edema of the foot (in the range of +2 and more)
7. The mother does not have gestational hypertension and preeclampsia
8. The mother does not have any known systemic diseases (such as heart disease, kidney disease, lung disease, diabetes, chronic hypertension and thrombophlebitis).
9. The mother should not have rope varicose veins in the foot area.
10. No lesions are visible at the site of massage and hydrotherapy
Do not take drugs that affect foot edema, such as furozamide, hydrochlorothiazide, acetazolamide and triamterene.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>1. The onset of gestational hypertension and preeclampsia
2. Reluctance to participate in the study and non-cooperation of the research sample at any time of the study
3. termination of pregnancy and preterm delivery for any reason
4. Failure to intervene in more than one case</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>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention groups: self care with effleurage massage,self care with hydrotherapy,selfe care with raised legs</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Degree of foot edema. Timepoint: First time: the first day of sample referral to the research environment and before the intervention, the second time: the day after the intervention. Method of measurement: the researcher places the index finger on the inner ankle of the specimen for 5 seconds and presses it if the indentation depth is greater than 2 mm to 4 mm and disappears in less than 15 seconds is second degree edema of the foot. If the depth of the depression is more than 4 mm to 7 mm and disappears in 15 to 30 seconds, edema of the foot is third degree. If the depth of the depression is more than 7 mm and it takes more than 30 seconds for it to disappear, the edema of the foot is grade 4.</prim_outcome>
      <prim_outcome>Ankle joint circumference. Timepoint: First time: the first day of sample referral to the research environment and before the intervention, the second time: the day after the intervention. Method of measurement: Inelastic meters.</prim_outcome>
      <prim_outcome>Instep circumference. Timepoint: First time: the first day of sample referral to the research environment and before the intervention, the second time: the day after the intervention. Method of measurement: Inelastic meters.</prim_outcome>
      <prim_outcome>Metatarsophalangeal joint circumference. Timepoint: First time: the first day of sample referral to the research environment and before the intervention, the second time: the day after the intervention. Method of measurement: Inelastic meters.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Ankle joint circumference. Timepoint: First time: on the first day of sample referral with the research environment - Second time: one day after the intervention. Method of measurement: Inelastic meters.</sec_outcome>
      <sec_outcome>Metatarsophalangeal joint circumference. Timepoint: First time: on the first day of sample referral with the research environment - Second time: one day after the intervention. Method of measurement: Inelastic meters.</sec_outcome>
      <sec_outcome>Instep circumference. Timepoint: First time: on the first day of sample referral with the research environment - Second time: one day after the intervention. Method of measurement: Inelastic meters.</sec_outcome>
      <sec_outcome>Age. Timepoint: On the first day of sample referral to the research environment, before the intervention. Method of measurement: Demographic Questionnaire.</sec_outcome>
      <sec_outcome>Job. Timepoint: On the first day of sample referral to the research environment, before the intervention. Method of measurement: Demographic Questionnaire.</sec_outcome>
      <sec_outcome>Education rate. Timepoint: On the first day of sample referral to the research environment, before the intervention. Method of measurement: Demographic Questionnaire.</sec_outcome>
      <sec_outcome>Next visit time. Timepoint: On the first day of sample referral to the research environment, before the intervention. Method of measurement: questionnaire.</sec_outcome>
      <sec_outcome>Gestational age. Timepoint: On the first day of sample referral to the research environment, before the intervention. Method of measurement: questionnaire.</sec_outcome>
      <sec_outcome>Number of pregnancy visits. Timepoint: On the first day of sample referral to the research environment, before the intervention. Method of measurement: questionnaire.</sec_outcome>
      <sec_outcome>Walking. Timepoint: On the first day of sample referral to the research environment, before the intervention. Method of measurement: questionnaire.</sec_outcome>
      <sec_outcome>Standing time during the day. Timepoint: On the first day of sample referral to the research environment, before the intervention. Method of measurement: questionnaire.</sec_outcome>
      <sec_outcome>Add salt to the tablecloth. Timepoint: On the first day of sample referral to the research environment, before the intervention. Method of measurement: questionnaire.</sec_outcome>
      <sec_outcome>Satisfaction with treatment. Timepoint: The day after the intervention. Method of measurement: Complication and Satisfaction Questionnaire.</sec_outcome>
      <sec_outcome>Satisfaction with training. Timepoint: The day after the intervention. Method of measurement: Complication and Satisfaction Questionnaire.</sec_outcome>
      <sec_outcome>Redness of the feet. Timepoint: The day after the intervention. Method of measurement: Complication and Satisfaction Questionnaire.</sec_outcome>
      <sec_outcome>Inflammation of the foot. Timepoint: The day after the intervention. Method of measurement: Complication and Satisfaction Questionnaire.</sec_outcome>
      <sec_outcome>Leg pain. Timepoint: The day after the intervention. Method of measurement: Complication and Satisfaction Questionnaire.</sec_outcome>
      <sec_outcome>Foot burning. Timepoint: The day after the intervention. Method of measurement: Complication and Satisfaction Questionnaire.</sec_outcome>
      <sec_outcome>Itching in place. Timepoint: The day after the intervention. Method of measurement: Complication and Satisfaction Questionnaire.</sec_outcome>
      <sec_outcome>Feeling of pain and discomfort in the uterus. Timepoint: The day after the intervention. Method of measurement: Complication and Satisfaction Questionnaire.</sec_outcome>
      <sec_outcome>Edema of the foot joint. Timepoint: First time: on the first day of referring the sample to the research environment, second time: on the day after the intervention. Method of measurement: The researcher places the index finger above the inner ankle of the sample foot for 5 seconds and presses there if the indentation depth is more than 2 mm to 4 mm and disappears in less than 15 seconds. The depression is more than 4 mm to 7 mm and disappears within 15 to 30 seconds, the foot edema is third degree. If the depth of the depression is more than 7 mm and it takes more than 30 seconds to disappear, the foot edema is fourth degree. .</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-02-22</approval_date>
        <contact_name>Ethics Committee in Research Schools of Pharmacy, Nursing and Midwifery - Shahid Beheshti University</contact_name>
        <contact_address>No.1, South Sajad jonoubi Ave, Khodayar hasani Ave, Chahardooli Blvd, Tehran Town Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
