<?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>IRCT2014061717237N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-09-17</date_registration>
      <primary_sponsor>Vice Chancellor for Research and Technology Deputy of Golestan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Acupressure on sleep quality and anxiety</public_title>
      <acronym></acronym>
      <scientific_title>The effect of acupressure on sleep quality and anxiety in hemodialysis patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-03-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>75</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/15895</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Other design features: Randomization strategies: &#13;
Considering sleep quality level, patients were allocated to three matched intervention, placebo and control groups. Allocation will be achieved using stratified random allocation.</study_design>
      <phase>3</phase>
      <hc_freetext>Chronic Renal failure.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Acupressure will be done on true acupoints (hand Shenmen, PC6 and Yintang) by using 3 to 4 kg pressure, with the practitioners' thumb in a period of two revolutions per second.The intervention will conduct three times a week for a month. Intervention 2: Placebo group: Massage will done in pseudo points with about 1 to 1.5 cm distance near to the true acupoints three times a week for a month. Intervention 3: Control group: Without any intervention. &#13;
During the study, If any intervention is required to modifying patients' anxiety and sleep disturbance, they will be excluded from study.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary>Introduction: In the end stage of renal disease, the patient is dependent on the alternative therapies of the kidney such as hemodialysis to continue the survival. The treatment with hemodialysis may provide the possibility of more survival for the patients, but it has an impact on the patients' physical and mental performance because of many complications and the patients' stressors and might stricken them to the psychological disorders. Sleep disturbance and anxiety are common problems in hemodialysis patients. This study was done to determine the effect of acupressure on sleep quality and anxiety of hemodialysis patients.&lt;br /&gt;&#13;
     Materials and methods: This study was done by the double-blind clinical trial on 74 hemodialysis patients at the hospital of 17Shahrivar of Borazjan in Bushehr province in 2014. First, eligible patients was chosen through a purposive sampling and then they were allocated into three intervention, placebo and control groups according to the sleeping score by classified random allocation method . &lt;br /&gt;&#13;
In the acupressure group, the points of Shen Men in hand (HT7), pericardium 6 (PC6) and Yintang was pressured in three minutes, three times a week for four weeks during hemodialysis. In the group of sham points, the massage with the same technique was done in the distant of 1.5-2 cm from the mentioned points and control group was received usual cares. &lt;br /&gt;&#13;
Data collection was done using 2 questionnaires; Spielberger State-Trait Anxiety Inventory and Pittsburgh Sleep Quality Index which was completed twice, before and after intervention, by the interview method. &lt;br /&gt;&#13;
The sleeping chart was completed from before intervention till one week after intervention daily by patients. Data were analyzed in SPSS-16 software using the chi-square, Dunnett test, ANOVA, t-test and their nonparametrictests. &lt;br /&gt;&#13;
Results: There was a significant difference comparing pre- and post-intervention data. The finding showed that, there was a significant relation between acupressure and sleep quality. The score of patients in acupressure group decreased from 12.1 to 7 after the intervention and this difference was significantin all components of sleep quality. The score of sleep quality in sham groupdecline from11.5 to 10.1 and significant difference in total score and parts to sleep and sleep disorders were observed too, but in the control group there was not significant difference in sleep quality and its components. Before the intervention, there was no significant difference between three groups with regard sleep habits, type of illness and drug use, quality of sleep and anxiety. But after the intervention, sleep quality difference between sham and acupressure group increased from 0.64 to 3.1 (about 3 times), and a control group of 0.74 significant difference to 4.4 (approximately 4-fold) increase. Sleep quality components including subjective sleep latency to sleep, sleep duration, sleep disorders and dysfunction as well as significant differences between the groups were observed, but there was no significant difference between three groups for score of sleep quality and hypnotic medication use . Sleep chart in one month showed in acupressure group, nighttime awakenings decreased compared to sham and control groups. The anxiety score decreased from 49.4 to 38.6 after the intervention in acupressure group. The mean anxiety score of sham and control group decreased from 47.8 to 46.04 and after from 49.4 to 51.2, respectively, but this difference was not significant changed. In addition,there was significant differences in the three groups after intervention in anxiety score. As Differences between sham and acupressure group decreased  from 1.6 before intervention to -7/4 after intervention, and difference between acupressure and control groups increased from -0.4 to 12.6 after intervention. According to the study results, acupressure was effective as 44.5 percent in sleep quality and 21.8 percent in improving the anxiety of patients. &lt;br /&gt;&#13;
Conclusions: The study findings confirmed the application of the acupressure as a non-pharmacological and complementary method in the points of  hand Shen Men, Yintang and Pc6 in the increase of sleep quality and decrease of anxiety of hemodialysis patients.</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>Abuzar Mehbudi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, Golestan University of Medical Sciences (Falsafi Complex), Hirkan Boulevard, Gorgan</address>
        <city>Gorgan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4917136536</zip>
        <telephone>+98 17 3242 6900</telephone>
        <email>mehbudi20@gmail.com</email>
        <affiliation>Golestan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahnaz Modanloo</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery, Golestan University of Medical Sciences (Falsafi Complex), Hirkan Boulevard, Gorgan</address>
        <city>Gorgan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4917136536</zip>
        <telephone>+98 17 3242 6900</telephone>
        <email>modanloo.mahnaz@goums.ac.ir; modanloo1@yahoo.com</email>
        <affiliation>Golestan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: age from 18 to 65 years; at least 6 months history of hemodialysis; three times hemodialysis in a week and four hours for each session; five or greater score in Pittsburgh Sleep Quality Index; having complete alertness, hearing and speech ability; having the ability to read and write; not having developing a psychiatric disorders which lead to consumption of psychiatric drugs; cancer; lupus erythematosus; dermatological disease; advanced heart failure; stroke;amputation; sore, infection or fistula in acupoints; Carpal Tunnel Syndrome (CTS). &#13;
Exclusion criteria: Patient hospitalization in intensive care unit, consumption of psychiatric drugs and distortion in mental status, death during intervention; the incidence of severe stressful event such as the death of someone close; not wanting to continue participation; travel; surgery and transplants lead to exclusion of subjects from the study.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N18.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic kidney disease, stage 5 (on dialysis)</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>Intervention group: Acupressure will be done on true acupoints (hand Shenmen, PC6 and Yintang) by using 3 to 4 kg pressure, with the practitioners' thumb in a period of two revolutions per second.The intervention will conduct three times a week for a month.</i_keyword>
      <i_keyword>Placebo group: Massage will done in pseudo points with about 1 to 1.5 cm distance near to the true acupoints three times a week for a month.</i_keyword>
      <i_keyword>Control group: Without any intervention. &#13;
During the study, If any intervention is required to modifying patients' anxiety and sleep disturbance, they will be excluded from study.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality of sleep. Timepoint: Before intervention and a week after four weeks intervention. Method of measurement: Pittsburgh Sleep Quality Index and Sleep Log.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Anxiety. Timepoint: Before intervention and a week after four weeks intervention. Method of measurement: State Trait Anxiety Inventory (STAI).</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 Chancellor for Research and Technology Deputy of Golestan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-06-08</approval_date>
        <contact_name>Ethical Committee</contact_name>
        <contact_address>Deputy of Research and Technology, Golestan University of Medical Sciences (Falsafi Complex), Hirkan Boulevard, Gorgan Gorgan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
