<?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>IRCT201302277494N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-08-11</date_registration>
      <primary_sponsor>Vice chancellor for research of Mazandaran University of Medical Science</primary_sponsor>
      <public_title>"The effect of acupressure with valerian Oil 2/5% on Quality and Quantity of sleep of patients with Acute coronary Syndrome (ACS)"</public_title>
      <acronym></acronym>
      <scientific_title>"The effect of acupressure with valerian Oil2/5% on Quality and Quantity of sleep of patients with Acute coronary Syndrome ( ACS)"</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-03-07</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/7955</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Sleep.</hc_freetext>
      <i_freetext>Intervention 1: Intervention in first group(  Valerian acupressure):Intervention in Acupressure with valerian oil's group such manner that this patient will received acupoint massage Second night in hospitalization, from the top of the head Respectively in Feng Chi(GB20) behind the head, Yin Tang in forehead, Ear Shen men, wrist Shen men(HT7) and Yungchuan at the sole bilaterally with 3 to 4 kilogram pressure two minute for every acupoint (five second massage and one second relax) A revolving of two seconds away with, A total of eighteen minutes for nine points with Valerian oil2/5% between 7 to 10 PM for three consecutive nights. Valerian oil is extracted of valerian root. In this study, valerian oil 2/5% is prepared from the massage center of Iran under the supervision of professors is reached to the desired concentration with almond base oil. Intervention 2: Intervention in third group( control): The control group every night between 7 to 10 PM will received shame acupoint massage(1-1/5 Centimeter from true acupoint) in Respectively in Feng Chi(GB20) behind the head, Yin Tang in forehead, Ear Shen men, wrist Shen men(HT7) and Yungchuan at the sole bilaterally with 3 to 4 kilogram pressure two minute for every acupoint (five second massage and one second relax) A revolving of two seconds away with, A total of eighteen minutes for nine points with Neutral Almond oil( available in drugstore) between 7 to 10 PM for three consecutive nights. Intervention 3: Intervention in second group ( acupressure): Acupressure's group will received acupoint massage from Second night in hospitalization, the top of the head Respectively in Feng Chi(GB20) behind the head, Yin Tang in forehead, Ear Shen men, wrist Shen men(HT7) and Yungchuan at the sole bilaterally with 3 to 4 kilogram pressure two minute for every acupoint (five second massage and one second relax) A revolving of two seconds away with, A total of eighteen minutes for nine points with Neutral almond oil( available in drugstore) between 7 to 10 PM for three consecutive nights.</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>Dr Mohammad Ali  Heydari Gorgi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Vesal St,Nasibeh School of Nursing and Midwifery, Sari</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 15 1226 7342</telephone>
        <email>heydarigorji@yahoo.com</email>
        <affiliation>Mazandaran  University of Medical Science</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Masumeh  Bagheri Nesami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing &amp; Midwifery Mazandaran University of Medical Sciences Sari, Iran.</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4816715793</zip>
        <telephone>+98 15 1226 7342</telephone>
        <email>anna3043@gmail.com, anna30432003@yahoo.com</email>
        <affiliation>Mazandaran  University of  Medical Scince</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The main inclusion criteria is at least eighteen years of age; being aware of the time and place of  not surgery; EF is above 40%.&#13;
The main exclusion criteria in this study received the opioid drug five or six hours of sleep the night before; despite hearing and vision impairments (such as not being able to communicate with the investigator if);  have addiction to drug; have an allergy to plants  and flowersand;  habit to use of any matter or procedure affecting the sleep; using inotropes drugs; leg amputation or ulcer at the site of acupoints; acute problems at admission and continuing to investigate the individual does not cooperate.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</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>Intervention in first group(  Valerian acupressure):Intervention in Acupressure with valerian oil's group such manner that this patient will received acupoint massage Second night in hospitalization, from the top of the head Respectively in Feng Chi(GB20) behind the head, Yin Tang in forehead, Ear Shen men, wrist Shen men(HT7) and Yungchuan at the sole bilaterally with 3 to 4 kilogram pressure two minute for every acupoint (five second massage and one second relax) A revolving of two seconds away with, A total of eighteen minutes for nine points with Valerian oil2/5% between 7 to 10 PM for three consecutive nights. Valerian oil is extracted of valerian root. In this study, valerian oil 2/5% is prepared from the massage center of Iran under the supervision of professors is reached to the desired concentration with almond base oil</i_keyword>
      <i_keyword>Intervention in third group( control): The control group every night between 7 to 10 PM will received shame acupoint massage(1-1/5 Centimeter from true acupoint) in Respectively in Feng Chi(GB20) behind the head, Yin Tang in forehead, Ear Shen men, wrist Shen men(HT7) and Yungchuan at the sole bilaterally with 3 to 4 kilogram pressure two minute for every acupoint (five second massage and one second relax) A revolving of two seconds away with, A total of eighteen minutes for nine points with Neutral Almond oil( available in drugstore) between 7 to 10 PM for three consecutive nights.</i_keyword>
      <i_keyword>Intervention in second group ( acupressure): Acupressure's group will received acupoint massage from Second night in hospitalization, the top of the head Respectively in Feng Chi(GB20) behind the head, Yin Tang in forehead, Ear Shen men, wrist Shen men(HT7) and Yungchuan at the sole bilaterally with 3 to 4 kilogram pressure two minute for every acupoint (five second massage and one second relax) A revolving of two seconds away with, A total of eighteen minutes for nine points with Neutral almond oil( available in drugstore) between 7 to 10 PM for three consecutive nights.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Quality. Timepoint: Before the study -The first to the fourth day of hospitalization. Method of measurement: SMHSQ.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quantity of sleep. Timepoint: Baseline and every day until the fourth day. Method of measurement: Sleep Log.</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 of Mazandaran University of Medical Science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-03-06</approval_date>
        <contact_name>Ethics Committee of Mazandaran University of Medical Sciences</contact_name>
        <contact_address>Vice chancellor for research, Moalem street, Moalem square Sari  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
