<?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>IRCT20190825044608N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-11-30</date_registration>
      <primary_sponsor>Shahroud University of Medical Sciences</primary_sponsor>
      <public_title>Review and compare of effect of local application Peppermint with Cold compress on the severity of pain due to the entry of needle into the arteriovenous fistula in dialysis patients</public_title>
      <acronym></acronym>
      <scientific_title>Review and compare of effect of local application Peppermint with Cold compress on the severity of pain due to the entry of needle into the arteriovenous fistula in dialysis patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-10-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>99</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/42791</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Since the participants will steadily enter into the study and the groups will have equal contributors, the 6-block method would be used for the randomization and its unit is individual. The random assignment sequence is obtained using the software by the methodology consultant. The qualified patient is registered by the first host and the assignment of participants into the groups is also performed by the same person based on the recorded model in the first stage. The random order would be conducted in secret. In detail, 99 packets are provided in the opaque package containing A, B, and C codes. A full informed consent are provided from all participants.The researcher will take the intended envelope in the specified sequence and perform according to the registered group in the envelope.</study_design>
      <phase>3</phase>
      <hc_freetext>Chronic kidney disease.</hc_freetext>
      <i_freetext>Intervention 1: for the group (A) 10 minutes before venipuncture, 5 ml of gel Peppermint (Mentorafort brand) in an area of 5 x 5 cm of the fistula will be applied by using an applicator. Intervention 2: For the group (B), the ice bag is placed on the skin 5 minutes before venipuncture. Intervention 3: Control group: For group C, a routine procedure for venipuncture will be performed.</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:
Unidentifiable patient data are shared.

When:
Start access period 1 year after publishing the results

To whom:
Available to researchers working in academic and scientific institutions

Conditions:
Use of documentation for medical research is permitted

Where to obtain:
Bita Koushki koushkib90@gmail.com

How to obtain:
Email your wishes to the email listed above and then receive the information within a week.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Bita Koushki</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahroud University of Medical Sciences, 7th Tir Square, Shahroud</address>
        <city>Shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۳۶۱۴۷۷۳۹۴۷</zip>
        <telephone>+98 23 3239 5054</telephone>
        <email>koushki@shmu.ac.ir</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hossein Ebrahimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahroud University of Medical Sciences, 7th Tir Square, Shahroud</address>
        <city>Shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۳۶۱۴۷۷۳۹۴۷</zip>
        <telephone>+98 23 3239 5054</telephone>
        <email>h_ebrahimi43@yahoo.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age over 18 to 65 years
Having complete vigilance
Hemodialysis patients undergoing dialysis at least 2 sessions per week
Patients who have at least 3 months past their fistula.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patient's Verbal and Mental Disabilities
Acute pain for any reason
Use painkiller 12 hours before venipuncture
A history of allergy to peppermint
Drug addiction and painkillers
The presence of damaged skin at the desired position</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N18</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic kidney disease (CKD)</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>for the group (A) 10 minutes before venipuncture, 5 ml of gel Peppermint (Mentorafort brand) in an area of 5 x 5 cm of the fistula will be applied by using an applicator.</i_keyword>
      <i_keyword>For the group (B), the ice bag is placed on the skin 5 minutes before venipuncture.</i_keyword>
      <i_keyword>Control group: For group C, a routine procedure for venipuncture will be performed</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: Immediately after needle insertion into the arteriovenous fistula. Method of measurement: Visual Analogue 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>Shahroud University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-09-30</approval_date>
        <contact_name>Ethics committee of Shahroud University of Medical Sciences</contact_name>
        <contact_address>Shahroud, Haftam Tir Square - Shahroud University of Medical Sciences and Health Services Shahroud Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
