<?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>IRCT20240106060628N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-02-16</date_registration>
      <primary_sponsor>Gonabad University of Medical Sciences</primary_sponsor>
      <public_title>Comparing of Valsalva maneuver and acupressure on pain of peripheral cannulation</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of Valsalva maneuver and auricular acupressure on pain intensity of peripheral venous cannulation</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-02-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>96</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/74867</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation will be by permutation blocks. Eligible patients, based on random allocation by permuted block randomization in the form of three blocks (ABC, ACB, BAC, BCA, CAB, CBA) in each of the three groups of Valsalva maneuver, acupressure (auriculotherapy), and routine care, will be placed. Concealment of the random allocation is also done using the method of sealed envelopes. In this method, the allocation sequence is placed inside the numbered envelopes, and the eligible patients are placed in each of the three groups based on the specified envelope to reduce selection bias.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Hypertensive heart disease. Condition 2: Abnormalities of breathing. Condition 3: Nausea and vomiting.</hc_freetext>
      <i_freetext>Intervention 1: In auricular acupressure group, patients are stimulated by the researcher for two minutes from the ear area and then peripheral cannulation is performed by the researcher. Intervention 2: In the Valsalva maneuver group, patients exhale for twenty seconds with a closed glottis, and then peripheral cannulation is performed by the researcher. Intervention 3: In the control group, the routine intervention of the ward, i.e. closing the tourniquet and then inserting the cannulation of the peripheral vein, is 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:
After the completion of the study, in addition to the report of the end of the project in the Pajoohan system, the article is published in English or Farsi, in which detailed information is provided about the method and data analysis. If more information is needed by the researchers, they can contact the authors of the study through email so that appropriate information is provided to them if necessary.

When:
Access will be available after the publication of the article.

To whom:
All those whom the data of the present study will help to disseminate scientific knowledge can send their request.

Conditions:
The use of data must:
- To promote science.
- Consider ethical issues
- Cite to the current article.

Where to obtain:
They can send their request through the email listed following:
hoseinirz941@gmail.com

How to obtain:
Immediately after the email request, they will be provided with the review request and the required data that does not cause any problems from an ethical point of view.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyed Reza Hosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 39, 15 Qaim St., Mashhad, Razavi Khorasan.</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9188757879</zip>
        <telephone>+98 51 3657 3015</telephone>
        <email>www.hoseinirz941@gmail.com</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyed Reza Hosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 39, 15 Qaim Street, Mashhad City, Razavi Khorasan Province.</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9188757879</zip>
        <telephone>+98 51 3657 3015</telephone>
        <email>www.hoseinirz941@gmial.com</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>- Patients over 18 years of age who are placed at level 5 and 4 of hospital triage
- Require for peripheral venous cannulation
- Access to the vein in the antecubital area of the forearm
- Not having a history of heart disease
- Not having acute pain
- No trauma
- Willingness to participate in the study
- Consciousness level of 15 based on Glasgow coma scale
- Not addiction
- Not taking sedatives and tranquilizers in the last six hours</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients who have a decreased level of consciousness during the study
Failure to cannulation in the first attempt</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I11</hc_code>
      <hc_code>R06</hc_code>
      <hc_code>R11</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Hypertensive heart disease</hc_keyword>
      <hc_keyword>Abnormalities of breathing</hc_keyword>
      <hc_keyword>Nausea and vomiting</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>In auricular acupressure group, patients are stimulated by the researcher for two minutes from the ear area and then peripheral cannulation is performed by the researcher.</i_keyword>
      <i_keyword>In the Valsalva maneuver group, patients exhale for twenty seconds with a closed glottis, and then peripheral cannulation is performed by the researcher.</i_keyword>
      <i_keyword>In the control group, the routine intervention of the ward, i.e. closing the tourniquet and then inserting the cannulation of the peripheral vein, is performed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Peripheral vein cannulation pain intensity based on Visual analogue scale. Timepoint: Immediately after peripheral vein cannulation. Method of measurement: Pain assessment scale including 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>Gonabad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-01-22</approval_date>
        <contact_name>Ethics committee of Gonabad University of Medical Sciences</contact_name>
        <contact_address>Vice Chancellor of Education, Research and Student Culture of Gonabad University of Medical Sciences - Razavi Khorasan Province-Gonabad-side of the Asian road Gonabad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
