<?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>IRCT2015070523044N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-04-06</date_registration>
      <primary_sponsor>Vice President of Research, School of Nursing and Midwifery, Isfahan University of Medical Sciences</primary_sponsor>
      <public_title>The Effectiveness of Acupressure on Severity of Depression in Hemodialysis Patients</public_title>
      <acronym></acronym>
      <scientific_title>The effect of acupressure on severity of depression in hemodialysis patients referred to hemodialysis units in hospitals of Isfahan in 2012</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2011-10-26</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>96</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/19755</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Fatique in hemodialysis patients.</hc_freetext>
      <i_freetext>Intervention 1: Intervention  in intervention group was conducted in the first 2 h of hemodialysisin the experimental and placebo groups. This interventionwas carried out among the subjects regularly undergoinghemodialysis, in both legs, hands, and the waist in threeweekly sessions for 4 weeks.[18] In the experimental group,the intervention was conducted on the major acupoints K1,GB 34, ST 36, SP 6, BL 23, and HT7.[22,23] In the placebogroup, it was carried out with 1 cm distance from the majorabove-mentioned acupoints. Each session lasted for 20min, of which 2 min were devoted for primary superficialstroking of the acupoints[24] and the rest of the time (18min) was for acupressure of the determined six acupoints(3 min for each acupoint). Intervention 2: The control group received no specific action was performed only routine care. Intervention 3: This intervention in the placebo group during the first 2 hours of hemodialysis. The intervention in both legs, both arms and waist and the people who were dialysis three times a week and regularly 3 sessions per week for 4 weeks was conducted. In the experimental group the main points of acupressure like k1, st36, sp6, bl23, ht7 and gb34. Each session lasted 20 minutes, 2 minutes Stroke initial surface to loosen the acupressure points and meridians and 18 minutes remaining open channels for pressing each of the six point (3 minutes anywhere) of these is a difference of the in the placebo group one centimeter away from the main point.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link>Introduction       Chronic kidney failure is one of the major public health problems in the world (Johnson et al., 2004). End stage renal disease (ESRD) is a stage of chronic renal failure that can be fatal without renal replacement therapies. Incidence o</results_url_link>
      <results_summary> Abstract &lt;br /&gt;&#13;
Background and objectives: Depression is the most common mental health problem in hemodialysis patients that can have a negative impact on patients' quality of life. This study aimed to determine the effect of acupressure on severity of depression in hemodialysis patients.&lt;br /&gt;&#13;
Methods: This study is a randomized clinical trial. Ninety-six hemodialysis patients in hemodialysis wards of Noor, Shariati, and Al-Zahra Hospitals were selected by convenient sampling method and randomly divided into three groups (32 patients) of intervention, placebo, and control groups. Data collection tools included a demographic questionnaire and Beck Depression Scale. Acupressure in the intervention and placebo groups was performed over 4 consecutive weeks, 3 times a week, each session lasting 20 minutes during the first 2 hours of dialysis at 6 acupressure points; with this difference that in the placebo group intervention was performed with one centimeter distance away from the true points. The control group received usual care. For data analysis, descriptive statistics, inferential (ANCOVA and LSD) and SPSS software version 11.5 was used.&lt;br /&gt;&#13;
Results: Analysis of covariance showed a significant difference in the mean score of depression’s severity in the intervention group (P=0.001), but no significant difference in the mean score of depression’s severity in placebo and control groups (P=0.22).&lt;br /&gt;&#13;
Conclusion: This study showed that acupressure reduced the severity of depression in hemodialysis patients and the use of this drug-free approach is suggested to hemodialysis nurses.&lt;br /&gt;&#13;
Keywords: acupre&lt;br /&gt;&#13;
                     </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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Leila Kalani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dezful University of Medical Sciences</address>
        <city>Dezful</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 61 4242 3308</telephone>
        <email>kalani.l@dums.ac.ir</email>
        <affiliation>Dezful University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Leila Kalani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dezful University of Medical Sciences</address>
        <city>Dezful</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 61 4242 3308</telephone>
        <email>kalani.l@dums.ac.ir</email>
        <affiliation>Dezful University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: age older than 18 years old;  diagnosis of ERSD; undergoing&#13;
hemodialysis at least for 3 months; the patients with chief complaine of fatigue and having fatigue score ≥5 based on fatigue severity visual analogue scale; lack of any wound or fracture; being in complete psychological and mental health to attend the study and fill the questionnaire, and not having undergone complementary medicine treatment in the past 3 months of the study. Exclusion criteria: patient’s absence for two sessions of acupressure&#13;
intervention and lack of interest to continue the study.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N18.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic kidney disease, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>N/A</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention  in intervention group was conducted in the first 2 h of hemodialysisin the experimental and placebo groups. This interventionwas carried out among the subjects regularly undergoinghemodialysis, in both legs, hands, and the waist in threeweekly sessions for 4 weeks.[18] In the experimental group,the intervention was conducted on the major acupoints K1,GB 34, ST 36, SP 6, BL 23, and HT7.[22,23] In the placebogroup, it was carried out with 1 cm distance from the majorabove-mentioned acupoints. Each session lasted for 20min, of which 2 min were devoted for primary superficialstroking of the acupoints[24] and the rest of the time (18min) was for acupressure of the determined six acupoints(3 min for each acupoint)</i_keyword>
      <i_keyword>The control group received no specific action was performed only routine care</i_keyword>
      <i_keyword>This intervention in the placebo group during the first 2 hours of hemodialysis. The intervention in both legs, both arms and waist and the people who were dialysis three times a week and regularly 3 sessions per week for 4 weeks was conducted. In the experimental group the main points of acupressure like k1, st36, sp6, bl23, ht7 and gb34. Each session lasted 20 minutes, 2 minutes Stroke initial surface to loosen the acupressure points and meridians and 18 minutes remaining open channels for pressing each of the six point (3 minutes anywhere) of these is a difference of the in the placebo group one centimeter away from the main point</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Fatigue. Timepoint: Before and two weeks after the intervention. Method of measurement: Piper Fatigue 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>Vice President of Research, School of Nursing and Midwifery, Isfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2011-10-25</approval_date>
        <contact_name>Isfahan University of Medical Sciences</contact_name>
        <contact_address>Isfahan University of Medical Sciences, Hezar Jarib St. Isfahan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
