<?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>IRCT20241103063578N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-11-23</date_registration>
      <primary_sponsor>College of Nursing, University of Baghdad</primary_sponsor>
      <public_title>Rhythmic Breathing Integrated with Hugo Point Acupressure V.S. Vapocoolant Spray on Pain Intensity During Needle Insertion into Arteriovenous Fistula in Hemodialysis Patients</public_title>
      <acronym></acronym>
      <scientific_title>Rhythmic Breathing Integrated with Hugo Point  Acupressure V.S. Vapocoolant Spray on Pain Intensity During Needle Insertion into Arteriovenous Fistula in Hemodialysis Patients:A Randomized Controlled Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-12-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/80153</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The sampling methodology encompasses a dual-phase procedure designed to procure representative constituents of the target population, specifically male patients undergoing hemodialysis who are subjected to needle insertion into arteriovenous fistulas.
In the initial phase, researcher will disseminate two distinct categories of cards: one denoting the patient's eligibility for participation in the study (orange), and the other signifying ineligibility (gray).
Patients who are in possession of the eligible card will subsequently select from one of five colored cards , each representing a different study condition:
White = Control group
Yellow = Rhythmic breathing only
Green = Hugo point acupressure only
Blue = Vapocoolant spray only
red = Rhythmic breathing integrated with Hugo point acupressure.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Hemodialysis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Rhythmic Breathing: Participants will practice deep breathing for 2 minutes before needle insertion, inhaling, holding, and exhaling for 3 seconds each. The exercise continues during needle insertion.Hugo Point Acupressure: The non-inserted hand will receive circular massage on the Hugo point for 2 minutes before and during needle insertion, with pressure applied for 10 seconds followed by 2 seconds of rest.Rhythmic Breathing + Hugo Point Acupressure: Participants will combine both interventions, engaging in rhythmic breathing while receiving Hugo point acupressure for 2 minutes before and during needle insertion.Vapocoolant Spray: The spray will be applied to the skin for 3-4 seconds, followed by a 10-second evaporation period before needle insertion.Pain intensity will be evaluated immediately after needle insertion in all interventions. Intervention 2: Control group: Control For the control group, no interventions will be done, and the pain will assess immediately after needle insertion in arteriovenus fistula.</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 researcher is acknowledging the scientific community to have verifiable findings of the study. sharing plan includes making all the related data available through publishing the study report in peer-reviewed reputable journals.

When:
God willing, once finishing the process of data collection, analysis and successfully publishing the manuscript, all the related files will become available for 6 months after publications

To whom:
All the related files will be shared with any scientific interested parties.

Conditions:
It may be used after seeking the author's permission and acknowledging his contribution.

Where to obtain:
The author's professional e-mail that will be available with the published manuscript can be used to contact the author. 
e-Mail: Hasan.band2302m@conursing.uobaghdad.edu.iq

How to obtain:
N/A

Comments:
Profound appreciations are due to the IRCT members for their genuine efforts in helping researchers fulfilling their academic endeavors.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hassan Raysan Mohammad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Souq Al-Shuyukh</address>
        <city>Al-Nasiriyah</city>
        <country1>Iraq</country1>
        <zip>64016</zip>
        <telephone>+964 1 521 1494</telephone>
        <email>Hasan.band2302m@conursing.uobaghdad.edu.iq</email>
        <affiliation>University of Baghdad, College of Nursing</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hassan Raysan Mohammad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Souq Al-Shuyukh</address>
        <city>Al-Nasiriyah</city>
        <country1>Iraq</country1>
        <zip>64016</zip>
        <telephone>+964 1 521 1494</telephone>
        <email>Hasan.band2302m@conursing.uobaghdad.edu.iq</email>
        <affiliation>University of Baghdad, College of Nursing</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iraq</country2>
      <country2>Iraq</country2>
      <country2>Iraq</country2>
      <country2>Iraq</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The participants must be male individuals who are receiving regular hemodialysis treatment
Alertness
The individuals participating in this study are required to be a minimum of 18 years old or older
Ability to speak
The participants are required to possess an arteriovenous fistula that serves as the access point for dialysis.
Participants who do not take analgesics
Not having diabetes for over 10 years</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Patients who are experiencing severe pain or discomfort that is not associated with the needle insertion procedure are to be excluded
Patients who have documented allergies or hypersensitivity reactions to vapocoolant spray
Patients who have undergone recent surgical procedures or have experienced trauma in proximity to the arteriovenous fistula are disqualified
Patients exhibiting cognitive impairment or mental health disorders that may hinder their ability to comprehend instructions or provide informed consent
Patients presenting with active infections or complications at the site of the arteriovenous fistula
Inflammation or injury at the Hugo point .</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R52</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Pain, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Rhythmic Breathing: Participants will practice deep breathing for 2 minutes before needle insertion, inhaling, holding, and exhaling for 3 seconds each. The exercise continues during needle insertion.Hugo Point Acupressure: The non-inserted hand will receive circular massage on the Hugo point for 2 minutes before and during needle insertion, with pressure applied for 10 seconds followed by 2 seconds of rest.Rhythmic Breathing + Hugo Point Acupressure: Participants will combine both interventions, engaging in rhythmic breathing while receiving Hugo point acupressure for 2 minutes before and during needle insertion.Vapocoolant Spray: The spray will be applied to the skin for 3-4 seconds, followed by a 10-second evaporation period before needle insertion.Pain intensity will be evaluated immediately after needle insertion in all interventions.</i_keyword>
      <i_keyword>Control group: Control For the control group, no interventions will be done, and the pain will assess immediately after needle insertion in arteriovenus fistula</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Primary outcome variable is the level of pain, which can be altered based on the Hugo point acupressure, Rhythmic breathing, and vapocoolant spray. Timepoint: Two minute before needle insertion and during insertion. Method of measurement: Visual analog scale (VAS) will be use  to assess intensity of pain.</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>The author of the trial is the funding source</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-10-28</approval_date>
        <contact_name>Ethics committee in college of nursing at University of Baghdad</contact_name>
        <contact_address>Bab-ALMuadham Baghdad Baghdad Iraq</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
