<?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>IRCT20190127042512N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-02-18</date_registration>
      <primary_sponsor>Oroumia University of Medical Sciences</primary_sponsor>
      <public_title>he effect of acupressure on the SP6 point and foot reflexology on sleep quality and fatigue in patients with lukemia</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effect of acupressure on the SP6 point and foot reflexology on sleep quality and fatigue in patients with lukemia hospitalized in Imam khomeini Hospital in Urmia in 2022</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-03-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>102</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68499</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The selected samples will be divided into two intervention groups and one control group using simple random sampling method. The method of random allocation into three groups was done by taking the cards (a), (b) and (c) by the patients, and the researcher divided the samples into three groups using the cards (a), (b) and (c). Acupressure, sole reflex massage and control will be divided. In this way, the patients who were included in the study, if card (a) is removed, will be included in the acupressure group, card (b) will be included in the sole reflex massage group, and card (c) will be included in the control group, Blinding description: Blinding in this study is single blind, so that the statistician is not aware of the study groups and the data analyst is not aware of which data are related to the intervention group and which data are related to the control group.</study_design>
      <phase>3</phase>
      <hc_freetext>Malignant neoplasms, stated or presumed to be primary, of lymphoid, haematopoietic and related tissue.</hc_freetext>
      <i_freetext>Intervention 1: FIRST Intervention group: In the acupressure group, in parallel with these routine cares, acupressure will be performed for each sample using the SP6 point for four weeks and every day (5 minutes) by the researcher. Intervention 2: SECOND Intervention group: In the foot massage therapy group, the intervention will be such that for the patients of this intervention group, after preparing the patient and greasing the soles of the feet with sweet almond oil, which is used for cold and wetness for all temperaments, every day for four consecutive weeks Reflexology is performed for 5 minutes on the treatment points on the soles of both feet. Intervention 3: Control group: No action is taken for the control 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:
All data is potentially shareable after de-identifying individuals

When:
The access period starts 6 months after the results are published

To whom:
Researchers working in academic and scientific institutions

Conditions:
Descriptive analyzes are allowed on the submitted dat

Where to obtain:
corresponding autho

How to obtain:
The request email should be sent to the corresponding author

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Amireh Hassanpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Urmia, Resalat Boulevard, Emergency Alley</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5714783734</zip>
        <telephone>+98 914 239 3134</telephone>
        <email>Amirehhassanpour@gmail.com</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Amireh Hassanpour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Urmia, Resalat Boulevard, Emergency Alley</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5714783734</zip>
        <telephone>+98 914 239 3134</telephone>
        <email>Amirehhassanpour@gmail.com</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Consent of patients to participate in the study
Conscious and oriented patients with stable health status
Suffering from chronic lymphoid leukemia
Age above 18 years and less than 80 years
Ability to speak Persian</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having chronic diseases such as diabetes, cardiovascular and respiratory diseases
Having mental disorders
receiving radiotherapy
Having an injury or surgery on the sole of the foot</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>C81-C96</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Malignant neoplasms, stated or presumed to be primary, of lymphoid, haematopoietic and related tissue</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>FIRST Intervention group: In the acupressure group, in parallel with these routine cares, acupressure will be performed for each sample using the SP6 point for four weeks and every day (5 minutes) by the researcher.</i_keyword>
      <i_keyword>SECOND Intervention group: In the foot massage therapy group, the intervention will be such that for the patients of this intervention group, after preparing the patient and greasing the soles of the feet with sweet almond oil, which is used for cold and wetness for all temperaments, every day for four consecutive weeks Reflexology is performed for 5 minutes on the treatment points on the soles of both feet.</i_keyword>
      <i_keyword>Control group: No action is taken for the control group</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sleep quality score In Pittsburgh Sleep Quality Index (PSQI). Timepoint: Measurement of sleep quality score before the intervention and one month after the intervention. Method of measurement: Pittsburgh Sleep Quality Index (PSQI).</prim_outcome>
      <prim_outcome>Fatigue score of Cancer Fatigue Scale Questionnaire. Timepoint: Measuring the fatigue score before the intervention and one month after the intervention. Method of measurement: Fatigue score of Cancer Fatigue Scale 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>Oroumia University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-11-08</approval_date>
        <contact_name>Research Ethics committee of Urmia University of Medical Sciences</contact_name>
        <contact_address>Urmia, Resalat Blvd, Emergency Alley Urmia West Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
