<?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>IRCT20211012052746N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-10-21</date_registration>
      <primary_sponsor>Ilam University of Medical Sciences</primary_sponsor>
      <public_title>The effect of massage therapy at Hugo point on venous catheter pain</public_title>
      <acronym></acronym>
      <scientific_title>The effect of massage therapy at Hugo point on venous catheter pain</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-10-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>68</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/59316</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: How to select samples for 68 people is a simple randomization method by drawing lots; first I write the number of beds in that section on each card and then we put the cards in a box and mix them together and after adding all the cards in the box, half of the cards are randomly taken out. Then, each patient that belongs to the selected number in the lottery list is entered into the study as a sample. Sampling in this study is without substitution. The unit of randomization is individual. Individuals included in the study are randomly divided into two groups: Control group (34 people) 2. Intervention group (34 people). In this grouping, it is tried that the people of the two groups are selected in terms of factors such as age and the same sex. In this research, no concealment has been done.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the intervention group, massage is performed for 3 minutes before and during the venipuncture procedure at Hugo point. Hugo is a spot on the palm of the hand between the thumb and forefinger. Before the venous catheter is inserted, the site of the hand Hugo point from which the vein is to be removed is massaged in a circular, gentle, medium-pressure manner. In all samples in the two study groups, the angiocatheter used will be pink and number 20. The scale for measuring pain in this study will be the use of the NRS numerical scale. On this scale, a person rates their pain using a scale of 0 to 10. Zero means painless and 10 means the worst pain situation: 0: no pain; 1-2-3: mild pain; 4-5-6: moderate to moderate pain; 7-8-9-10: Severe pain is considered. Intervention 2: Control group: In this group, the venipuncture department will be performed in the usual way and no intervention will be done for this group.</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:
The present study is a clinical trial study that will be performed with the participation of 68 people referring to the inpatient wards of Imam Khomeini Hospital in Ilam. They are randomly selected and written; then, each patient who entered the relevant sections according to the selected number, for example, is included in the study. Then, they are randomly classified into two groups. وند Become: 1. Control group (34 people) 2. Intervention group (34 people).

When:
Sample takes place from 1400/8/8 to 1401/2/2

To whom:
The data will be available to researchers working in academic and scientific institutions, people working in industry and research students

Conditions:
Inclusion criteria: people aged 18 to 75 years; The severity of the pain for which people have been referred to the hospital is less than 6 (moderate pain) according to the NRS; Awareness of place, time and person; Ability to communicate and no psychological problems in the client. Exclusion criteria: unwillingness to cooperate; Lack of awareness of the client about the place, time and person; The client's pain for which he or she was referred to the hospital is greater than 6 according to the NRS; Use of pain relievers eight hours before the procedure for venipuncture, fractures and inflammation at the massage point

Where to obtain:
Via email razyehvaladbeigi@gmail.com or postal address of Ilam _Janbazan neighborhood. Malek Shoara Street, corner of Shohada Momeni alley

How to obtain:
Duration seven days to fourteen days

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Razyeh Valadbeigi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Janbazan_Malek Al-Sho'ra Street_Angle of Momeni Martyrs Alley</address>
        <city>Ilam</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6931175371</zip>
        <telephone>+98 84 3222 9388</telephone>
        <email>razyehvaladbeigi@gmail.com</email>
        <affiliation>Ilam University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Razyeh Valadbeigi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Janbazan_Malek Al-Sho'ra Street_Angle of Momeni Martyrs Alley</address>
        <city>Ilam</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6931175371</zip>
        <telephone>+98 84 3222 9388</telephone>
        <email>razyehvaladbeigi@gmail.com</email>
        <affiliation>Ilam University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>People are 18 to 75 years old
The severity of the pain for which people have been referred to the hospital is less than 6 (moderate pain) according to the NRS
Awareness of place, time and person; Ability to communicate and no psychological problems in the client.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Reluctance to cooperate
Lack of awareness of the client to the place, time and person
The client's pain for which he or she was referred to the hospital is greater than 6 according to the NRS
Use of pain relievers eight hours before the transfusion procedure
Fractures and inflammation at the massage point</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G89</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pain, not elsewhere classified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the intervention group, massage is performed for 3 minutes before and during the venipuncture procedure at Hugo point. Hugo is a spot on the palm of the hand between the thumb and forefinger. Before the venous catheter is inserted, the site of the hand Hugo point from which the vein is to be removed is massaged in a circular, gentle, medium-pressure manner. In all samples in the two study groups, the angiocatheter used will be pink and number 20. The scale for measuring pain in this study will be the use of the NRS numerical scale. On this scale, a person rates their pain using a scale of 0 to 10. Zero means painless and 10 means the worst pain situation: 0: no pain; 1-2-3: mild pain; 4-5-6: moderate to moderate pain; 7-8-9-10: Severe pain is considered.</i_keyword>
      <i_keyword>Control group: In this group, the venipuncture department will be performed in the usual way and no intervention will be done for this group</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Intravenous catheter entry pain. Timepoint: 3 minutes during and before the venipuncture procedure. Method of measurement: NRS numerical rating 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>Ilam University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-10-11</approval_date>
        <contact_name>Ethics Committee of Ilam University of Medical Sciences</contact_name>
        <contact_address>Janbazan_Malek Al-Sho'ra Street_Angle of the Martyrs of Momeni Alley Ilam Ilam Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
