<?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>IRCT2016090429694N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-06-02</date_registration>
      <primary_sponsor>Vice chancellor for research of Babol University of Medical Sciences</primary_sponsor>
      <public_title>Studying the effect of Sleep Hygiene Education on sleep quality of adult women with comparing two groups of control &amp; intervention.</public_title>
      <acronym>-</acronym>
      <scientific_title>Investigating the effect of sleep hygiene education on sleep quality of older women.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-06-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/23806</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: Limited randomized will be based on random specific method. After determining whole sample volume, the names of persons will be put in lottery container. Then the names of 35 persons in the first step will be taken out that belong to intervention group and the rest belong to control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Sleep quality.</hc_freetext>
      <i_freetext>Intervention 1: Interventions: The educational content of the first to the fifth session will last 45, 50, 40, 40 and 30 minutes, respectively. The interval between sessions is exactly one week. These trainings include avoiding factors that disturb sleep, preparing a proper sleep environment, the role of diet and exercise in improvement of sleep quality, effects of smoking on sleep, educating behavioral interventions including deep breathing, relaxation techniques, imaginary drawing and muscle relaxation. Intervention 2: Control group: The Pittsburg questionnaire is only filled out twice in the interval of one month.</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>Mehrnaz Montazeri Lemrasky</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery Fatemeh Zahra (SA), Imam Sajjad Hospital, Enghelab Square</address>
        <city>Ramsar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4691714141</zip>
        <telephone>+98 11 5522 6393</telephone>
        <email>montazeri3000@yahoo.com</email>
        <affiliation>Babol University of Medical Science,Ramsar Fatemeh Zahra(SA) School Of Nursing and Midwifery</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Abbas Shamsalinia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ramsar Fatemeh Zahra (SA)  School of Nursing and Midwifery,  Imam Sajjad Hospital, Enghelab Square</address>
        <city>Ramsar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4691714141</zip>
        <telephone>+98 115225151</telephone>
        <email>a.shamsalinia@mubabol.ac.ir; abbasshamsalinia@yahoo.com</email>
        <affiliation>Babol University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: include, age between 60-74 years old, living in Gorgan city, being able to support oneself using ADL instrument and not having cognitive disorders with obtaining the score higher than 6 with the scale of MAT and obtaining the score higher than 7 based on Epworth sleep instrument and having a tendency for participating in this research. Exclusion criteria include: Those women who have had an unpleasant event such as: their relative’s death during previous year, using specific diet (hydro therapy, vegetarian, raw veganism) , not participating in educational sessions of sleep hygiene, doing Yoga sport at the time of doing this research</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>73 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G47</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Sleep disorder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Interventions: The educational content of the first to the fifth session will last 45, 50, 40, 40 and 30 minutes, respectively. The interval between sessions is exactly one week. These trainings include avoiding factors that disturb sleep, preparing a proper sleep environment, the role of diet and exercise in improvement of sleep quality, effects of smoking on sleep, educating behavioral interventions including deep breathing, relaxation techniques, imaginary drawing and muscle relaxation</i_keyword>
      <i_keyword>Control group: The Pittsburg questionnaire is only filled out twice in the interval of one month.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sleep quality. Timepoint: Before intervention, End of fifth session Intervention. Method of measurement: Pittsburg questionnaire sleep quality Index.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Subjective quality of sleep. Timepoint: Sleep quality one time before intervention and the second time at the end of last session. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Sleep latency. Timepoint: Sleep quality one time before intervention and the second time at the end of last session. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Habitual sleep efficiency. Timepoint: Sleep quality one time before intervention and the second time at the end of last session. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Sleep duration. Timepoint: Sleep quality one time before intervention and the second time at the end of last session. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Use of  sleeping medication. Timepoint: Sleep quality one time before intervention and the second time at the end of last session. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Sleep disturbances. Timepoint: Sleep quality one time before intervention and the second time at the end of last session. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Daytime dysfunction. Timepoint: Sleep quality one time before intervention and the second time at the end of last session. Method of measurement: Questionnaire.</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 Babol University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-07-10</approval_date>
        <contact_name>Ethics committee of Babol University of Medical Sciences</contact_name>
        <contact_address>Babol University of Medical Science, Ganjafrooz Ave Babol  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
