<?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>IRCT20200727048223N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-09-29</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of massage and acupressure on skin itching</public_title>
      <acronym></acronym>
      <scientific_title>The comparison slow stroke back massage and acupressure effect on skin pruritus in hemodialysis patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-10-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>54</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49922</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the permutation block method was used to generate a sequence of random allocation of samples(by individual) to the study groups. Random allocation sequences were performed using randomization software and block size two. The permutation block method is one of the random allocation methods in which each block is selected according to the number of groups studied. In this study, there are two blocks, AB and BA. One of the blocks is selected at random. If the first block, AB, is selected, the first person is assigned to group A and the second person to group B. And this process continues until all the samples are assigned. The characteristic of this method is that the two study groups will have equal numbers.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Chronic kidney disease. Condition 2: skin pruritus.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Perform 12 sessions of slow stroke massage from the neck to the sacral area, 3 sessions per week and 10 minutes per session. Intervention 2: Intervention group: Perform 12 sessions of acupressure in points (LI 11 at the outer end of the cubital) and (SP 10 in the area above the upper corner of the patella of the knee) 3 sessions per week and each session for 5 minutes at each point.</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:
In this study, all participants' data (demographic information, laboratory indicators and questionnaire scores) will be available after being identified.

When:
Access period starts 3 months after the results are published

To whom:
Researchers working in academic institutions

Conditions:
Academic researchers will be able to submit requests for data, and all quantitative and qualitative inferential and analytical analyzes of the data will be allowed.

Where to obtain:
Sina salati . salatis982@mums.ac.ir
Tayebe Pourghaznein. PourghazneinT@mums.ac.ir

How to obtain:
The applicant must write a formal application to the corresponding author, announcing his application. After approval and coordination with the Vice Chancellor for Research, the study data will be sent to the applicant formally and confidentially.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Tayebe Pourghaznein</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery,Daneshgah Ave., Ibn Sina Ave., Khorasan Razavi, Mashhad,</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>38591511 051</telephone>
        <email>PourghazneinT@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Tayebe Pourghaznein</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery,Daneshgah Ave., Ibn Sina Ave., Khorasan Razavi, Mashhad,</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>PourghazneinT@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Willingness to participate in the study
Acceptable visual, auditory and consciousness ability to answer questions
Undergoing hemodialysis for at least 6 months
Referring to hemodialysis 3 sessions 4 hours a week
The presence of mild to severe skin itching based on the visual scale of itching and a score between 1 to 10 at least 2 weeks before the test
Dialysis solution temperature between 36.5 to 37.5 ° C
Age between 18 to 80 years</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>liver diseases
Amputation in the lower and upper limbs
Existence of any itchy skin lesions
Existence of open wound or infection in the intervention area
Use traditional medicine to relieve itching 1 week before the test
Body temperature above 37.8 ° C</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N18.5</hc_code>
      <hc_code>L29.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic kidney disease, stage 5</hc_keyword>
      <hc_keyword>Pruritus, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Perform 12 sessions of slow stroke massage from the neck to the sacral area, 3 sessions per week and 10 minutes per session</i_keyword>
      <i_keyword>Intervention group: Perform 12 sessions of acupressure in points (LI 11 at the outer end of the cubital) and (SP 10 in the area above the upper corner of the patella of the knee) 3 sessions per week and each session for 5 minutes at each point</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Itching of the skin. Timepoint: Measurement of skin itching at the beginning of the study, weekly and at the end of the study after massage and acupressure interventions. Method of measurement: Yosipovitch Itching Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The effect of itchy skin on daily activities. Timepoint: At the beginning of the study, 7 days, 14 days, 21 days and 28 days after the start of massage and acupressure. Method of measurement: Yosipovitch pruritus questionnaire.</sec_outcome>
      <sec_outcome>Effect of skin itching on sleep. Timepoint: At the beginning of the study, 7 days, 14 days, 21 days and 28 days after the start of massage and acupressure. Method of measurement: Yosipovitch pruritus questionnaire.</sec_outcome>
      <sec_outcome>Effect of skin itching on quality of life. Timepoint: At the beginning of the study, 7 days, 14 days, 21 days and 28 days after the start of massage and acupressure. Method of measurement: Yosipovitch pruritus questionnaire.</sec_outcome>
      <sec_outcome>Emotional skin itching dimension. Timepoint: At the beginning of the study, 7 days, 14 days, 21 days and 28 days after the start of massage and acupressure. Method of measurement: Yosipovitch pruritus questionnaire.</sec_outcome>
      <sec_outcome>Skin itching severity. Timepoint: At the beginning of the study, 7 days, 14 days, 21 days and 28 days after the start of massage and acupressure. Method of measurement: Yosipovitch pruritus questionnaire.</sec_outcome>
      <sec_outcome>Location of itching. Timepoint: At the beginning of the study, 7 days, 14 days, 21 days and 28 days after the start of massage and acupressure. Method of measurement: Yosipovitch pruritus questionnaire.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-07-12</approval_date>
        <contact_name>Ethics committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Daneshgah Ave, Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
