<?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>IRCT20191218045773N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-05-04</date_registration>
      <primary_sponsor>Esfarayen University of Medical Sciences</primary_sponsor>
      <public_title>Comparing the effects of massage and tapping on success of catheter insertion</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effects of massage and tapping on the duration and first success rate of peripheral intravenous catheter insertion in aged patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>160</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/44514</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Randomization description: The randomization method is simple. Random units are each of elderly patients that admitted to the emergency department. Also, The randomization tool is  a random number table. The researcher select one of the numbers in the random numbers table and moves to the right and down. Record the numbers and assign them to different study groups whose numbers are already specified.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Patients reffered to Emergency ward.</hc_freetext>
      <i_freetext>Intervention 1: In the massage group, the blood pressure cuff is wrapped around the patient's arm and inflated till 60 mm Hg. Expert nurse will rub patient hand (catheter insertion site) for 30 sec till change the color of the skin. Each hand movement (upping or downing on the skin) is performed within one second. Then, site of catheter insertion will be disinfected with alcohol 70%. The catheter N.20 will be inserted in the site of determined. Intervention 2: In the Tapping group, the blood pressure cuff is wrapped around the patient's arm and inflated till 60 mm Hg. Nurse will tap soft kicks from 5 c.m distance of patient hand (catheter  insertion site) for 30 sec. Each tapping movement will be done within 1 second. Then, site of catheter insertion will be disinfected with 70% alcohol. The catheter N.20 will be inserted in the site of determined. Intervention 3: In mixed group (massage and tapping) the blood pressure cuff is wrapped around the patient's arm and inflated till 60 mm Hg. Expert nurse will rub patient hand (catheter insertion site) for 30 sec till change the color of the skin. Each hand movement (upping or downing on the skin) is performed within one second. Then, Nurse will tap soft kicks from 5 c.m distance of patient hand (catheter  insertion site) for one minute. Each tapping movement will be done within 1 second. Then, site of catheter insertion will be disinfected with 70% alcohol. The catheter N.20 will be inserted in the site of determined. Intervention 4: In the control group,  the blood pressure cuff is wrapped around the patient's arm and inflated till 60 mm Hg for 30 sec. Expert nurse without any other intervention will determine site of catheter insertion and disinfected with 70% alcohol. The catheter N.20 will be inserted in the site of determined.</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:
Document will be registered "Pajouhan" system after completion of the study . Also, participants general information and the effectiveness of interventions will be recorded in the article.

When:
Accessibility after publish of article

To whom:
People interested in nursing scope

Conditions:
People looking for ways to facilitate catheter insertion in pediatric who can access the data

Where to obtain:
Esfarāyen Faculty of Medical Sciences, Imama Reza S.t, Esfarāyen, North Khorasan

How to obtain:
They can access to data through below email as soon as possible s.j.hoseini2016@gmail.com

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyed Javad Hosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Esfarāyen Faculty of Medical Sciences , Imama Reza S.t, Esfarāyen, North Khorasan</address>
        <city>Esfarayen</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9661777944</zip>
        <telephone>0098 5831550000- 602</telephone>
        <email>s.j.hoseini2016@gmail.com</email>
        <affiliation>Esfarayen University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyed Javad Hosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Esfarāyen Faculty of Medical Sciences , Imam Reza St, Esfarāyen, North Khorasan</address>
        <city>Esfarayen</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>96617-77944</zip>
        <telephone>+98 58 3155 0000-602</telephone>
        <email>s.j.hoseini2016@gmail.com</email>
        <affiliation>Esfarayen University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Participants have age over than 65 years old
catheter insertion difficulty rate is between 2 to 5 with Difficult Intravenous Access (DIVA) instrument</inclusion_criteria>
      <agemin>65 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The patient has emergency conditions
Not willing to participate in the study
catheter insertion Failure for first attempt</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>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the massage group, the blood pressure cuff is wrapped around the patient's arm and inflated till 60 mm Hg. Expert nurse will rub patient hand (catheter insertion site) for 30 sec till change the color of the skin. Each hand movement (upping or downing on the skin) is performed within one second. Then, site of catheter insertion will be disinfected with alcohol 70%. The catheter N.20 will be inserted in the site of determined.</i_keyword>
      <i_keyword>In the Tapping group, the blood pressure cuff is wrapped around the patient's arm and inflated till 60 mm Hg. Nurse will tap soft kicks from 5 c.m distance of patient hand (catheter  insertion site) for 30 sec. Each tapping movement will be done within 1 second. Then, site of catheter insertion will be disinfected with 70% alcohol. The catheter N.20 will be inserted in the site of determined.</i_keyword>
      <i_keyword>In mixed group (massage and tapping) the blood pressure cuff is wrapped around the patient's arm and inflated till 60 mm Hg. Expert nurse will rub patient hand (catheter insertion site) for 30 sec till change the color of the skin. Each hand movement (upping or downing on the skin) is performed within one second. Then, Nurse will tap soft kicks from 5 c.m distance of patient hand (catheter  insertion site) for one minute. Each tapping movement will be done within 1 second. Then, site of catheter insertion will be disinfected with 70% alcohol. The catheter N.20 will be inserted in the site of determined.</i_keyword>
      <i_keyword>In the control group,  the blood pressure cuff is wrapped around the patient's arm and inflated till 60 mm Hg for 30 sec. Expert nurse without any other intervention will determine site of catheter insertion and disinfected with 70% alcohol. The catheter N.20 will be inserted in the site of determined.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>First attempt success rate for inserting of peripheral venous catheter. Timepoint: Immediately after fixation of catheter on the skin. Method of measurement: Possible to injection of "water for injection" from top of the catheter without causing swelling at the top of catheter insertion.</prim_outcome>
      <prim_outcome>Inserting of peripheral venous catheter duration. Timepoint: Since initiation catheter insertion until it is fixed in place. Method of measurement: Using the stopwatch.</prim_outcome>
      <prim_outcome>The time spent to find a peripheral venous. Timepoint: Since the fasten of tourniquet to start inserting of peripheral venous catheter. Method of measurement: Using the stopwatch.</prim_outcome>
      <prim_outcome>Patient satisfaction from each of protocols. Timepoint: After completion of catheter insertion. Method of measurement: Using the questionnaire.</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>Esfarayen University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-12-09</approval_date>
        <contact_name>Ethics committee of Esfarayen faculity of Medical Sciences</contact_name>
        <contact_address>Faculity of Medical Sciences, Imam Reza St, Esfarayen, North Khorasan Esfarayen North Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
