<?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>IRCT20211204053272N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-01-01</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>The effect of plantar reflexology on fatigue and pain after cesarean section</public_title>
      <acronym></acronym>
      <scientific_title>A Comparision Study of the Effect of foot reflexology with and without violet oil on fatigue, pain after cesarean section in patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>126</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/60489</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is done in a simple and individual way using Randomizer random allocation software. Individuals are listed according to the national code and then divided into groups 1 (reflexology with violet oil), group 2 (reflexology without oil) and group 3 (control) using random allocation software, Blinding description: Only the researcher knows which patient is in the control group and which is receiving reflexology with oil or without oil. Patients are not aware of their groups.</study_design>
      <phase>1-2</phase>
      <hc_freetext>Cesarean section.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: The reflexology intervention of the sole of the foot will be performed with violet oil. After washing the patients's soles and drying them while lying down, the researcher will perform a foot reflexology with 3-5 cc of violet oil for 40 minutes (20 minutes for each foot). The number of intervention sessions will be four times a week for two consecutive days (twice a day at intervals of 6-8 hours). The intervention begins after the patient has RBR (8 to 10 hours after cesarean section) and subsequent reflexology sessions will be performed at approximately a fixed time interval. Diclofenac suppositories are given at each stage of the study if severe pain and analgesia are needed. Intervention 2: Intervention group 2: The foot reflexology intervention will be performed without violet oil. After washing the patients's soles and drying them while lying down, the researcher will perform foot reflexology without violet oil for 40 minutes (20 minutes for each foot). The number of intervention sessions will be four times a week for two consecutive days (twice a day at intervals of 6-8 hours). The intervention begins after the patient has RBR (8 to 10 hours after cesarean section) and subsequent reflexology sessions will be performed at approximately a fixed time interval. Diclofenac suppositories are given at each stage of the study if severe pain and analgesia are needed. Intervention 3: Control group: In this group are cesarean section patients who are not subjected to any intervention. Patients in this group are only monitored. Diclofenac suppositories are given at each stage of the study if severe pain and analgesia are needed.</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:
Article

When:
2022

To whom:
Researchers working in academic and scientific institutions

Conditions:
1- Reference in articles and dissertations 2- Having a code of ethics in your studies 3- Valid academic emails

Where to obtain:
Esmat Mardani
Hazrat Fatemeh Shiraz School of Nursing and Midwifery
Esmatmardani6609@gmail.com
00989173894438

How to obtain:
Communication via valid email

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Ghavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Namazi Square "Namazi Hospital" Fatemeh School of Nursing and Midwifery, Shiraz, Iran</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۳۱۱۹ - ۷۱۹۳۶</zip>
        <telephone>+98 71 3644 7254</telephone>
        <email>ghavi.fatemeh@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Ghavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Namazi Square "Namazi Hospital" Fatemeh School of Nursing and Midwifery, Shiraz, Iran</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۳۱۱۹ - ۷۱۹۳۶</zip>
        <telephone>+98 71 3647 4254</telephone>
        <email>ghavi.fatemeh@yahoo.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Being 18-45 years old
Literacy
Perform cesarean section with spinal anesthesia
Complete pregnancy and healthy baby and high Apgar score of the first minute
No allergies to used oils
No skin problems in the massage area
Do not use narcotic sedatives in the last eight hours
Do not be under general anesthesia</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Having severe postoperative complications such as excessive bleeding, infection, eclampsia, hospitalization in intensive care units
Reluctance to cooperation during stages 2 and 3</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O75.82</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Onset (spontaneous) of labor after 37 completed weeks of gestation but before 39 completed weeks gestation, with delivery by (planned) cesarean section</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: The reflexology intervention of the sole of the foot will be performed with violet oil. After washing the patients's soles and drying them while lying down, the researcher will perform a foot reflexology with 3-5 cc of violet oil for 40 minutes (20 minutes for each foot). The number of intervention sessions will be four times a week for two consecutive days (twice a day at intervals of 6-8 hours). The intervention begins after the patient has RBR (8 to 10 hours after cesarean section) and subsequent reflexology sessions will be performed at approximately a fixed time interval. Diclofenac suppositories are given at each stage of the study if severe pain and analgesia are needed.</i_keyword>
      <i_keyword>Intervention group 2: The foot reflexology intervention will be performed without violet oil. After washing the patients's soles and drying them while lying down, the researcher will perform foot reflexology without violet oil for 40 minutes (20 minutes for each foot). The number of intervention sessions will be four times a week for two consecutive days (twice a day at intervals of 6-8 hours). The intervention begins after the patient has RBR (8 to 10 hours after cesarean section) and subsequent reflexology sessions will be performed at approximately a fixed time interval. Diclofenac suppositories are given at each stage of the study if severe pain and analgesia are needed.</i_keyword>
      <i_keyword>Control group: In this group are cesarean section patients who are not subjected to any intervention. Patients in this group are only monitored. Diclofenac suppositories are given at each stage of the study if severe pain and analgesia are needed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fatigue. Timepoint: Before studying and one hour after studying. Method of measurement: Multidimensional Fatigue Inventory scale.</prim_outcome>
      <prim_outcome>Pain. Timepoint: Before studying and one hour after studying. Method of measurement: Visual Analog Scale.</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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-09-25</approval_date>
        <contact_name>Ethics committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Zand St., in front of Palestine St., the central building of Shiraz University of Medical Sciences, Shiraz,Iran Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
