<?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>IRCT20170122032101N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-01-16</date_registration>
      <primary_sponsor>Shahre-kord University of Medical Sciences</primary_sponsor>
      <public_title>Comparing the effect of Melissa officinalis tea versus Matricaria Chamomilla tea on pain intensity, anxiety, and satisfaction with pain management</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effect of Melissa officinalis tea versus Matricaria Chamomilla tea on pain intensity, anxiety, and satisfaction with pain management in patients undergoing lower limb orthopedic surgury</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-01-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>96</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/28464</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: the sample for this study is 96 patients which will allocate to three groups (chamomile, melissa officinalis, control) with blocking randomization method. for randomization, 32 block with capacity of 3 patients will be made. blocking will be based on demographic data (age group, sex, addiction). each patient is first allocated to a block based on his or her demographic data, then, based on drawing a letter, the patients allocates to one of the study groups. allocation of second and third patinet of each block to study groups, will be based on previos patints on that block.</study_design>
      <phase>N/A</phase>
      <hc_freetext>lower limb orthopaedic surgery.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: melissa officinalis group: for this group, melissa officinalis tea bag produced by golnoosh darband company will prescribe. each tea bag contains 1g melissa officinalis. melissa officinalis tea will prescribe three times per day in 6AM, 2PM AND 10PM. each time, 1 tea bag containing melissa officinalis will put in 150 cc of boiling wate and then consumed by the patient. Intervention 2: Intervention group: matricaria chamomilla group: for this group, matricaria chamomilla tea bag produced by golnoosh darband company will prescribe. each tea bag contains 1g matricaria chamomilla. since time of intervetions mus be eaual in all three groups, therefore, matricaria chamomilla tea will prescribe 3 times a day in similar times with melissa officinals group. Intervention 3: Control group: or this group, black tea will prescribe at above mentioned times.</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 there are no more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Reza saidi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>nursing faculty, shahrelord university of medical sciences, rahmatiyeh</address>
        <city>shahre-kord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8871633411</zip>
        <telephone>+98 38 3334 6714</telephone>
        <email>saidi.reza@gmail.com</email>
        <affiliation>Shahre-kord University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>haydeh heidari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>nursing faculty, shahrekord university of medical sciences, rahmatiyeh</address>
        <city>shahre-kord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8871633411</zip>
        <telephone>+98 38 3333 5648</telephone>
        <email>heidari.h@skums.ac.ir</email>
        <affiliation>Shahre-kord University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>patient undergoing lower limb orthopaedic surgery
willingness to participate in the study
normal gag reflex after surgery
age 15 and over
moderate and sever pain intensity (point 4 and above in VAS scale)
orientation to time, place and person
no prescription of anxiolytic drug
Absence of underlying disease causing pain and anxiety
lack of history of sensitivity to Melissa officinalis and Matricaria Chamomilla
no prescription of warffarin
no prescription benzodiazepines and sedative drugs
lack of asthma
normal kidney and liver function</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>pregnant women
children</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>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: melissa officinalis group: for this group, melissa officinalis tea bag produced by golnoosh darband company will prescribe. each tea bag contains 1g melissa officinalis. melissa officinalis tea will prescribe three times per day in 6AM, 2PM AND 10PM. each time, 1 tea bag containing melissa officinalis will put in 150 cc of boiling wate and then consumed by the patient.</i_keyword>
      <i_keyword>Intervention group: matricaria chamomilla group: for this group, matricaria chamomilla tea bag produced by golnoosh darband company will prescribe. each tea bag contains 1g matricaria chamomilla. since time of intervetions mus be eaual in all three groups, therefore, matricaria chamomilla tea will prescribe 3 times a day in similar times with melissa officinals group.</i_keyword>
      <i_keyword>Control group: or this group, black tea will prescribe at above mentioned times.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain intensity score in visual analogue scale. Timepoint: before interventions and 30 minutes after prescribtion of each dose. Method of measurement: visual analogue scale.</prim_outcome>
      <prim_outcome>Anxiety score in Spielberger state anxiety inventory. Timepoint: before interventions and 30 minutes after prescribtion of each dose. Method of measurement: Spielberger state anxiety inventory.</prim_outcome>
      <prim_outcome>Satisfaction with pain management score in satisfaction with pain management questionaire. Timepoint: before interventions and 30 minutes after prescribtion of each dose. Method of measurement: satisfaction with pain management questionaire.</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>Shahre-kord University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-09-17</approval_date>
        <contact_name>Ethics committee of shahre-kord University of Medical Sciences</contact_name>
        <contact_address>Ayatollah kashani blvd shahre-kord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
