<?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>IRCT20190724044321N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-06-12</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the Effect of Anethum graveolens L. seed Essential oil on Intestinal Function and Post Cesarean Pain.</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the Effect of Anethum graveolens L. seed Essential oil on Intestinal Function and Post Cesarean Pain.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/41288</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Blocked by random allocation method, The mothers were divided into two groups, intervention A and control group B. According to the sample size, 5 blocks of 4 (AABB, BBAA, ABAB, AAAA, BBBB) were placed and were divided into two equal groups of intervention and control, Blinding description: In this trial, only the health care provider and the data analyzer (data review with codes A and B) were blinded. Due to the lack of placebo, it was not possible to blind the researcher and the research unit.</study_design>
      <phase>3</phase>
      <hc_freetext>K59.9 Functional intestinal disorder , unspecified 082 single delivery by caesarean section.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In order to prepare Essential oil , dill seeds were approved by the expert of the Department of Medicinal Plants (Herbalium) of Mashhad University of Medical Sciences after preparing them from reputable commercial sources. The grains were then crushed and the essential oil was prepared by hydro distillation using the Clevenger device and dried on sodium sulfate without water and stored in a closed vial at 4  Celsius. 1 cc of the required oil was obtained from 100 grams of dried dill seeds. The required oil was dissolved in a hydro alcoholic solvent (ethanol / water / 80/20) and then poured into 20 cc bottles. The ratio of oil to solvent is 1: 3.The intervention was performed 4 hours after the operation and after completing the relevant forms; In the intervention group, 40 drops of dill seeds were diluted in 30 cc of tap water and given to the patient. Plumbing water was given to the patient, and after 20 minutes again after measuring with the appropriate instrument, the patient was given the third dose similar to the previous two doses. 20 minutes after the end of the third intervention and then every 4 hours +- 30 minutes to 12 hours after the end of the cesarean section, bowel function and pain were measured and recorded again. Intervention 2: Control group: In this study, due to the start of the intervention in 4 hours after cesarean section and considering that the patient is NPO up to 12 hours after the operation, the control group is without placebo and only receives routine treatment but in 4 hours after cesarean section. Every 20 minutes to 3 times and then every 4 hours for 30 minutes to 12 hours after the relevant cesarean section to complete the bowel function and pain will be completed.</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:
Effect of Anethum graveolensL. seed Essential oil on Intestinal Function and Post Cesarean Pain

When:
2020

To whom:
Midwifery students

Conditions:
Systematic review

Where to obtain:
Email

How to obtain:
Articles published in this field will be sent to the applicant.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zohreh Yousefi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>53, between Golnar 3 and 5, Golnar Street, neyshabour, Iran.</address>
        <city>neyshabour</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>93168-65411</zip>
        <telephone>+98 51 4322 1495</telephone>
        <email>yousefizh961@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sedigheh Yousefzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Ibn Sina St., Mashhad, Iran.</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>yousefzadehs@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Be Iranian.
The age  is between 18 - 35 years.
Have a minimum of literacy.
Not be third and more cesarean section or emergency cesarean section.
Sign the Satisfaction letter form.
Be Sensory Cesarean section is a spinal and lower transverse incision of the uterus and "fanneistiel" incision.
The mother should be fully conscious.
The baby should be single and alive and should not be hospitalized in the neonatal intensive care unit.
The gestational age should be 37 weeks or more based on the first day of the last menstrual period or the first trimester of pregnancy.
Do not have speech-hearing problems or an accent that prevents communication with the researcher.
Not addicted to drugs, alcohol or tobacco.
During the last 6 months, he has not been subjected to major stress (serious illness of himself and his wife, death of a loved one, migration, accident and severe family disputes).
Do not suffer from medical conditions (diabetes, preeclampsia, liver, heart, respiratory, kidney, coagulation, epilepsy, paralysis, mental disorders diagnosed by a psychiatrist or psychologist, vascular thrombosis, autoimmune diseases including MS).
Has not used herbal medicines for the past 24 hours.
The mother's oral temperature should not be equal to or greater than 38. C.
Not  be severe depressed, anxious, or stressed
It is not known to be sensitive to  Anethum graveolens L. seed</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>35 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Mother's refusal to participate in Continues research
Complications after cesarean section: high blood pressure, bleeding requiring blood transfusion
Maternal fever
Observe any possible Complications of  Anethum graveolens L. seed Essential oil</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K59.9 -  0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>K59.9 Functional intestinal disorder , unspecified 082 single delivery by caesarean section</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: In order to prepare Essential oil , dill seeds were approved by the expert of the Department of Medicinal Plants (Herbalium) of Mashhad University of Medical Sciences after preparing them from reputable commercial sources. The grains were then crushed and the essential oil was prepared by hydro distillation using the Clevenger device and dried on sodium sulfate without water and stored in a closed vial at 4  Celsius. 1 cc of the required oil was obtained from 100 grams of dried dill seeds. The required oil was dissolved in a hydro alcoholic solvent (ethanol / water / 80/20) and then poured into 20 cc bottles. The ratio of oil to solvent is 1: 3.The intervention was performed 4 hours after the operation and after completing the relevant forms; In the intervention group, 40 drops of dill seeds were diluted in 30 cc of tap water and given to the patient. Plumbing water was given to the patient, and after 20 minutes again after measuring with the appropriate instrument, the patient was given the third dose similar to the previous two doses. 20 minutes after the end of the third intervention and then every 4 hours +- 30 minutes to 12 hours after the end of the cesarean section, bowel function and pain were measured and recorded again.</i_keyword>
      <i_keyword>Control group: In this study, due to the start of the intervention in 4 hours after cesarean section and considering that the patient is NPO up to 12 hours after the operation, the control group is without placebo and only receives routine treatment but in 4 hours after cesarean section. Every 20 minutes to 3 times and then every 4 hours for 30 minutes to 12 hours after the relevant cesarean section to complete the bowel function and pain will be completed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Before the intervention and then every 20 minutes to 3 times and then every 4 hours ± 30 minutes to 12 hours after cesarean section. Method of measurement: McGill Pain 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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-10-22</approval_date>
        <contact_name>Ethics Committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Qureshi Building, University Street, Mashhad, Iran. Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
