<?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>IRCT2014103019761N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-01-10</date_registration>
      <primary_sponsor>Sabzevar University of Medical Science</primary_sponsor>
      <public_title>Acupressure effect on sleep quality in patients with chronic heart failure</public_title>
      <acronym></acronym>
      <scientific_title>Acupressure effect on sleep quality in patients with chronic heart failure</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-08-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/17596</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Sleep.</hc_freetext>
      <i_freetext>Intervention 1: The third group (control group), a group that receives the usual routine procedures.These sleep quality with SMHSQ questionnaire at the time of admission (for the study of sleep in the house), on the morning of the second, third, fourth and fifth admitted between the hours of 7 to 8 am will be reviewed by the project partners. Intervention 2: The second group intervention (The false point): these patients, the second night in hospital the point with 1-1.5 cm distance of shenmen point of bilaterally with a pressure of about 3 to 4 kg massage for five minutes receive (5 seconds massage and one second rest) for a period of two revolutions per second with a thumb rest for three consecutive nights between 7pm to 10pm. These sleep quality with SMHSQ questionnaire at the time of admission (for the study of sleep in the house), on the morning of the second, third, fourth and fifth admitted between the hours of 7 to 8 am will be reviewed by the project partners. Intervention 3: Intervention in first group(acupressure): these patients, the second night in hospital shenmen point bilaterally with a pressure of about 3 to 4 kg massage for five minutes receive (5 seconds massage and one second rest) for a period of two revolutions per second with a thumb rest for three consecutive nights between 7pm to 10pm. These sleep quality with SMHSQ questionnaire at the time of admission (for the study of sleep in the house), on the morning of the second, third, fourth and fifth admitted between the hours of 7 to 8 am will be reviewed by the project partners.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Reza Bordbar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>22 Bahman Hospital، Emam Khomeini Street</address>
        <city>Neyshaboor</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9613873136</zip>
        <telephone>+98 51 4263 6423</telephone>
        <email>rezabordbar54@yahoo.combordbarr1@nums.ac.ir</email>
        <affiliation>Sabzevar University of Medical Science</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Roya Akbarzade</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery، Sabzevar University of Medical Science</address>
        <city>Sabzevar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9613873136</zip>
        <telephone>+98 51 4444 6070</telephone>
        <email>roakbarzadeh53@gmail.com</email>
        <affiliation>Sabzevar University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:Patients with systolic heart failure and left ventricular ejection fraction (Ef) is greater than 20 and less than 40%؛ In the absence of any injury at the shenmen  point؛ No history of acupressure ؛ Having awareness؛  listening and speaking abilities at an acceptable level to accountability؛ Minimum 40 and maximum 65 years&#13;
Exclusion criteria:Unwillingness to continue participation in the study؛ Out of reach of the patient(Death،discharge)؛ Get opium for 5 to 6 hours before bedtime؛ Use sedative drugs</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F51.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Nonorganic disorder of the sleep-wake schedule</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>The third group (control group), a group that receives the usual routine procedures.These sleep quality with SMHSQ questionnaire at the time of admission (for the study of sleep in the house), on the morning of the second, third, fourth and fifth admitted between the hours of 7 to 8 am will be reviewed by the project partners.</i_keyword>
      <i_keyword>The second group intervention (The false point): these patients, the second night in hospital the point with 1-1.5 cm distance of shenmen point of bilaterally with a pressure of about 3 to 4 kg massage for five minutes receive (5 seconds massage and one second rest) for a period of two revolutions per second with a thumb rest for three consecutive nights between 7pm to 10pm. These sleep quality with SMHSQ questionnaire at the time of admission (for the study of sleep in the house), on the morning of the second, third, fourth and fifth admitted between the hours of 7 to 8 am will be reviewed by the project partners.</i_keyword>
      <i_keyword>Intervention in first group(acupressure): these patients, the second night in hospital shenmen point bilaterally with a pressure of about 3 to 4 kg massage for five minutes receive (5 seconds massage and one second rest) for a period of two revolutions per second with a thumb rest for three consecutive nights between 7pm to 10pm. These sleep quality with SMHSQ questionnaire at the time of admission (for the study of sleep in the house), on the morning of the second, third, fourth and fifth admitted between the hours of 7 to 8 am will be reviewed by the project partners.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sleep quality. Timepoint: Before the intervention-   First to fourth day of hospitalization. Method of measurement: SMHSQ Sleep Quality 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>Sabzevar University of Medical Science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-08-04</approval_date>
        <contact_name>Ethics Committee of Sabzevar University of Medical Sciences</contact_name>
        <contact_address>Vice chancellor for research of Sabzevar University of Medical Science, 5th km of Sabzevar to Tehran Road, Sabzevar Sabzevar  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
