<?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>IRCT20120109008665N11</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-03-28</date_registration>
      <primary_sponsor>Semnan University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Acupressure on sleep quality of nursing students in internship period</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Acupressure on sleep quality of nursing students in internship period</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2020-04-08</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/46514</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Students will be randomly assigned to three groups of A:acupressure, B: placebo acupressure, and C: control using 90 sealed envelopes containing the letters A, B, and C equally. Students will select the envelope themselves.</study_design>
      <phase>N/A</phase>
      <hc_freetext>sleep disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the first group (Acupressure) after getting informed consent, student will complete demographic, pitsburgh sleep quality and spielberger questionnaires. The wristband, which has a plastic button with a diameter of 0.7 cm, is closed for one month each night before going to bed on both the right and left wrists of the patient so that the plastic button is placed on the point of intervention (Shenmen or HT7 point). The pressure is applied to the extent that the student does not feel discomfort or pain in the wrist. Intervention 2: Intervention group: In the second group (false acupressure) after getting informed consent, student will complete demographic, pitsburgh sleep quality and spielberger questionnaires. The wristband, which has a plastic button with a diameter of 0.7 cm, is closed for one month each night before going to bed on both the right and left wrists of the patient so that the plastic button is placed on opposite the point of intervention (false point). The pressure is applied to the extent that the student does not feel discomfort or pain in the wrist. Intervention 3: Control group: In the third group (control) after getting informed consent, student will complete demographic, pitsburgh sleep quality and spielberger questionnaires. This group does not receive any special intervention.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hassan Babamohamadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and Midwifery Faculty, Semnan University of Medical Sciences, 5 Kilometers of Damghan Road, Semnan, Iran</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3513138111</zip>
        <telephone>+98 23 3365 4192</telephone>
        <email>babamohammady2007@gmail.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hassan Babamohamadi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and Midwifery Faculty, Semnan University of Medical Sciences, 5 Kilometers of Damghan Road, Semnan, Iran</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3513138111</zip>
        <telephone>+98 23 3365 4192</telephone>
        <email>babamohammady2007@gmail.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>nursing student of Shahid Beheshti University of Medical Sciences
studying in 7th semester of nursing (internship)
no history of neuropsychiatric illness leading to hospitalization or use of psychiatric drugs
no history of sleep disturbances in a recent month
no scars at the Shenmen and placebo point
non-use sleep medication during the past month
no history of acupressure</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Carpal tunnel syndrome
Students engaged in student work
BMI above 35
State and trait anxiety score over 60</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F51.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other sleep disorders not due to a substance or known physiological condition</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: In the first group (Acupressure) after getting informed consent, student will complete demographic, pitsburgh sleep quality and spielberger questionnaires. The wristband, which has a plastic button with a diameter of 0.7 cm, is closed for one month each night before going to bed on both the right and left wrists of the patient so that the plastic button is placed on the point of intervention (Shenmen or HT7 point). The pressure is applied to the extent that the student does not feel discomfort or pain in the wrist.</i_keyword>
      <i_keyword>Intervention group: In the second group (false acupressure) after getting informed consent, student will complete demographic, pitsburgh sleep quality and spielberger questionnaires. The wristband, which has a plastic button with a diameter of 0.7 cm, is closed for one month each night before going to bed on both the right and left wrists of the patient so that the plastic button is placed on opposite the point of intervention (false point). The pressure is applied to the extent that the student does not feel discomfort or pain in the wrist.</i_keyword>
      <i_keyword>Control group: In the third group (control) after getting informed consent, student will complete demographic, pitsburgh sleep quality and spielberger questionnaires. This group does not receive any special intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sleep Quality. Timepoint: Baseline, 10, 20 days and end of study (day after the end of intervention). Method of measurement: Pittsburgh 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>Semnan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-03-10</approval_date>
        <contact_name>Semnan University of Medical Sciences</contact_name>
        <contact_address>Vice Chancellor of Research and Technology, Semnan University of Medical Sciences, Basidj Blv, Semnan, Iran Semnan Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
