<?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>IRCT2013100614910N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2014-01-21</date_registration>
      <primary_sponsor>Mashhad University of Medical Science</primary_sponsor>
      <public_title>The effect of acupressure on sleep quality</public_title>
      <acronym></acronym>
      <scientific_title>The effect of acupressure on sleep quality in menopausal women in Mashhad: A Randomized Clinical Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2009-12-29</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>105</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/14370</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>sleep quality.</hc_freetext>
      <i_freetext>Intervention 1: Acupressure group: They were asked to massage the effective pressure points as a self-care method at home. The points were Shenmen on the wrist crease, Sanyinjiao point (SP6) on both feet, Fengchi on the hairline of the back neck (occipital area) and Yintang, at the top of the nose on the center line between the ends of the eyebrows. Intervention was done 1 to 2 hours before sleeping, each night (except Fridays) by circular massage with a 1 Cm circle diameter for 4 weeks. Participants were trained for the force of finger pressure. They needed to feel the full pressure of approximately 3-4 kg on the points but no feeling of pain. Intervention 2: Sham acupressure group: They were asked to massage the sham pressure points as a self-care method at home. Non-acupoints, which were 1 to 3 CUN (Chinese unit of length) away from true acupoints(Shenmen, Sanyinjiao, Fengchi, Yintang) were used in sham acupressure group. These points were out of the route of energy. Intervention was done 1 to 2 hours before sleeping, each night (except Fridays) by circular massage with a 1 Cm circle diameter for 4 weeks. Participants were trained for the force of finger pressure. They needed to feel the full pressure of approximately 3-4 kg on the points but no feeling of pain. Intervention 3: The control group:  They received the weekly control of blood pressure and speech communication for 4 weeks.</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>Zahra Abedian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ebne-Sina street, Mashhad, Iran</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 51 1859 1511</telephone>
        <email>abedianz@mums.ac.ir</email>
        <affiliation>Mashhad School of Nursing and Midwifery</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zahra Abedian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ebne- Sina Street Mashhad, Iran</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 51 1859 1511</telephone>
        <email>abedianz@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria :spending at least 12 months after amenorrhea or Follicle Stimulating Hormone (FSH) serum level ≥ 40(1 year menopause);  healthy of the pressure points, having a full conscious and also having an acceptable ability of listening and speaking to receive training and doing the self- care techniques at home; no having mental and physical disorders; getting a score higher than 5 from the Pittsburgh Sleep Quality Index (PSQI) ; able to sit for about 30 minutes.&#13;
Exclusion criteria: having emotional stress during the last 6 months ;  having specific eating diets; addicted to narcotic drugs; using the drugs causing sleep disorders; suffering from special disease;  taking hormonal drugs during 3 last months; using herbal medicine to improve the menopausal symptoms;  body mass index (BMI) higher than 30;  having the moderate and severe depression based on Beck Depression Inventory;  feeling of severe fatigue and anxiety; having circular job specially night job; lack of cooperation with researchers</inclusion_criteria>
      <agemin>41 years</agemin>
      <agemax>65 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G47.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Sleep disorder, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Acupressure group: They were asked to massage the effective pressure points as a self-care method at home. The points were Shenmen on the wrist crease, Sanyinjiao point (SP6) on both feet, Fengchi on the hairline of the back neck (occipital area) and Yintang, at the top of the nose on the center line between the ends of the eyebrows. Intervention was done 1 to 2 hours before sleeping, each night (except Fridays) by circular massage with a 1 Cm circle diameter for 4 weeks. Participants were trained for the force of finger pressure. They needed to feel the full pressure of approximately 3-4 kg on the points but no feeling of pain.</i_keyword>
      <i_keyword>Sham acupressure group: They were asked to massage the sham pressure points as a self-care method at home. Non-acupoints, which were 1 to 3 CUN (Chinese unit of length) away from true acupoints(Shenmen, Sanyinjiao, Fengchi, Yintang) were used in sham acupressure group. These points were out of the route of energy. Intervention was done 1 to 2 hours before sleeping, each night (except Fridays) by circular massage with a 1 Cm circle diameter for 4 weeks. Participants were trained for the force of finger pressure. They needed to feel the full pressure of approximately 3-4 kg on the points but no feeling of pain.</i_keyword>
      <i_keyword>The control group:  They received the weekly control of blood pressure and speech communication for 4 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sleep quality in menopausal women. Timepoint: before &amp; after interveantion. Method of measurement: Pittsburgh Sleep Quality Index (PSQI).</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> NCT01904578</sec_id>
        <issuing_authority>clinicaltrials.gov</issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Mashhad University of Medical Science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-01-13</approval_date>
        <contact_name>Mashhad University of Medical Science</contact_name>
        <contact_address>Daneshgah street, Mashhad,Iran Mashhad  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
