<?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>IRCT20141222020401N7</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-01-05</date_registration>
      <primary_sponsor>Yasouj University of Medical Sciences</primary_sponsor>
      <public_title>The effect of chamomile aromatherapy with and without oxygen on severity of pain, bloating and nausea in women after cesarean section with spinal anesthesia.</public_title>
      <acronym></acronym>
      <scientific_title>The effect of chamomile aromatherapy with and without oxygen on severity of pain, bloating and nausea in women after cesarean section with spinal anesthesia.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-01-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>136</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/42769</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Factorial, Purpose: Prevention, Randomization description: The randomized block allocation method with standard 4-person blocks was used and the subjects were divided into 3 intervention groups and one control group, with labels A, B, C, D on four sheets and and oxygen interventions. Aromatherapy, oxygen therapy, aromatherapy and control were also written on four separate sheets, and a colleague who was unaware of this was asked to randomly remove a label for each intervention. In this way we had four random groups and four factorial twenty-four blocks. The size of each block was four and their order was different. Then the blocks were randomly assigned by placement and the patients were sorted. Each block of patients was assigned randomly, Blinding description: Due to the smell of chamomile, it was not possible to blind the researcher and participants, but the analyst has no information about the type of intervention related to each data.</study_design>
      <phase>N/A</phase>
      <hc_freetext>pain, nausea and distention  of women in post Cesarean section with spinal anesthesia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention of chamomile aromatherapy with oxygen (chamomile essential oil from Zardband Company) is given to patients about the general purpose of the research and informed consent is obtained from them and their spouse. Training on collecting these samples is required to collect information and a baseline questionnaire including demographic and morphometric information is collected. On the day that is selected as intervention day 1, patients in the intervention group will be rubbed with a patch test on a wrist (patch test) and covered with a cloth for 2 minutes to determine if they are allergic. Delete the study.In this intervention group, a drop of chamomile essential oil plus distilled water is poured into a small nebulizer that attaches to the facial mask and adjusts to 6 liters per minute (28), which is a drop of essential oil when entering the women's ward. Chamomile with distilled water is poured into a small nebulizer attached to the face mask and oxygen is adjusted for 6 liters per minute (delay test(At 6, 6.30 and 7 hours after the operation, the mask is applied to the patient's face for 5 minutes each time. 5-12 liters per minute with a simple mask can deliver 35-50% oxygen to the patient. Intervention 2: Dual Oxygen Intervention alone, Double Intervention at the same time will receive 6 liters of oxygen per minute with simple face mask without aromatherapy chamomile. Intervention 3: Intervention group: Intervention third chamomile aromatherapy alone, Intervention group three will receive chamomile aromatherapy at the same time after sensitization test with oxygen nebulizer. Intervention 4: The control group did not receive oxygen and aromatherapy chamomile.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is A decision will be made after the article is published.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Nazafarin Hosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hazrat Zaynab nursing school . Dr. shahid jalil Street, Yasuj , Iran</address>
        <city>Yasuj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7591994799</zip>
        <telephone>0098 33235140</telephone>
        <email>Hosseinichenar@yahoo.com</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Nazafarin Hosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hazrat Zaynab Nursing School. Dr. shahid jalil Street, Yasuj , Iran</address>
        <city>Yasuj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7591994799</zip>
        <telephone>+98 74 3323 5140</telephone>
        <email>Hosseinichenar@yahoo.com</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>no history of middle ear disease, preeclampsia or eclampsia, asthma and other acute and chronic diseases
No smoking or alcohol drinking
No history of allergy to chamomile
No history of olfactory problems
Cesarean section should be performed with spinal anesthesia</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Change the anesthesia method
Other than cesarean section
The patient needs special care</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>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention of chamomile aromatherapy with oxygen (chamomile essential oil from Zardband Company) is given to patients about the general purpose of the research and informed consent is obtained from them and their spouse. Training on collecting these samples is required to collect information and a baseline questionnaire including demographic and morphometric information is collected. On the day that is selected as intervention day 1, patients in the intervention group will be rubbed with a patch test on a wrist (patch test) and covered with a cloth for 2 minutes to determine if they are allergic. Delete the study.In this intervention group, a drop of chamomile essential oil plus distilled water is poured into a small nebulizer that attaches to the facial mask and adjusts to 6 liters per minute (28), which is a drop of essential oil when entering the women's ward. Chamomile with distilled water is poured into a small nebulizer attached to the face mask and oxygen is adjusted for 6 liters per minute (delay test(At 6, 6.30 and 7 hours after the operation, the mask is applied to the patient's face for 5 minutes each time. 5-12 liters per minute with a simple mask can deliver 35-50% oxygen to the patient</i_keyword>
      <i_keyword>Dual Oxygen Intervention alone, Double Intervention at the same time will receive 6 liters of oxygen per minute with simple face mask without aromatherapy chamomile</i_keyword>
      <i_keyword>Intervention group: Intervention third chamomile aromatherapy alone, Intervention group three will receive chamomile aromatherapy at the same time after sensitization test with oxygen nebulizer</i_keyword>
      <i_keyword>The control group did not receive oxygen and aromatherapy chamomile.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Bloating. Timepoint: 6 hours after cesarean section, 12 hours after cesarean section, 18hours after cesarean section. Method of measurement: visual analog scale.</prim_outcome>
      <prim_outcome>Pain. Timepoint: 6 hours after cesarean section, 12 hours after cesarean section, 18 hours after cesarean section. Method of measurement: visual analog scale.</prim_outcome>
      <prim_outcome>Nausea. Timepoint: 6 hours after cesarean section, 12 hours after cesarean section, 18 hours after cesarean section. 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>Yasouj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-06-25</approval_date>
        <contact_name>Ethics committee of Yasuj University of Medical Sciences</contact_name>
        <contact_address>Assistance of Research and Technology of the University , Yasouj University of Medical Sciences , Shahid Motahari Blvd., Yasuj , Iran Yasuj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
