<?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>IRCT20180730040644N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-03-07</date_registration>
      <primary_sponsor>University of social welfare and rehabilitation sciences</primary_sponsor>
      <public_title>The effect of different e-learning methods on the mental health of the elderly during corona disease</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effectiveness of various virtual education methods on the mental health of the elderly during the corona disease epidemic, Shiraz, 2021</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-01-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61947</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance.</study_design>
      <phase>N/A</phase>
      <hc_freetext>-.</hc_freetext>
      <i_freetext>Intervention 1: First intervention group: sending a text message. The intervention is offered three sessions a week for a period of two months -This intervention will include relaxation techniques, positive mental imagery, muscle relaxation, meditation exercises, meaning therapy, sleep, sleep hygiene, stimulus control. Intervention 2: Second Intervention group: sending an audio message. The intervention is offered three sessions a week for a period of two months -This intervention will include relaxation techniques, positive mental imagery, muscle relaxation, meditation exercises, meaning therapy, sleep, sleep hygiene, stimulus control. Intervention 3: Third Intervention group: sending a multimedia clip. The intervention is offered three sessions a week for a period of two months -This intervention will include relaxation techniques, positive mental imagery, muscle relaxation, meditation exercises, meaning therapy, sleep, sleep hygiene, stimulus control.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Results of pre-test and post-test data analysis

When:
After the publication of articles extracted from the research project

To whom:
University professors - staff of health centers

Conditions:
To evaluate the effectiveness of e-learning methods

Where to obtain:
Farzaneh Bahadori

How to obtain:
by Email
bahadori_farzaneh@yahoo.com

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nasim Pirzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Health Promotion, School of Health, Shiraz university of Medical Sciences. Razi Ave</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7153675541</zip>
        <telephone>+98 71 5367 5541</telephone>
        <email>N.pirzadeh7238@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farzaneh Bahadori</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran University of Rehabilitation Sciences and Social Health, Evin, Daneshjoo Blvd., Koodkiar dead end</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985713834</zip>
        <telephone>+98 917 813 6507</telephone>
        <email>bahadori_farzaneh@yahoo.com</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Minimum literacy
Having a smartphone
Active users in cyberspace (membership in virtual groups and approval of activity in groups by the group manager)
earning a score of 24 ≥ from the Amon Summary Mental Assessment (MMSE)
Score 7 ≤  for the Depression and Anxiety and Stress Scale (DASS)
score 12% for the Depression, Anxiety and Stress Scale
Score 16≤ from the Pittsburgh Sleep Quality Questionnaire</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>74 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Withdrawal from cooperation after entering the intervention
No active participation in the group (no daily viewing of messages, no answering calls and no participation in virtual discussions that take place in the group)
Under pharmacological and non-pharmacological treatments for mental and sleep disorders
History of attending e-learning classes on stress, anxiety and sleep disorders
history of severe mental disorders
Untreated vision and hearing disorders (do not wear glasses for vision problems and do not use hearing aids for severe hearing impairments)
Loss of a close relative during the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>-</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>First intervention group: sending a text message. The intervention is offered three sessions a week for a period of two months -This intervention will include relaxation techniques, positive mental imagery, muscle relaxation, meditation exercises, meaning therapy, sleep, sleep hygiene, stimulus control.</i_keyword>
      <i_keyword>Second Intervention group: sending an audio message. The intervention is offered three sessions a week for a period of two months -This intervention will include relaxation techniques, positive mental imagery, muscle relaxation, meditation exercises, meaning therapy, sleep, sleep hygiene, stimulus control.</i_keyword>
      <i_keyword>Third Intervention group: sending a multimedia clip. The intervention is offered three sessions a week for a period of two months -This intervention will include relaxation techniques, positive mental imagery, muscle relaxation, meditation exercises, meaning therapy, sleep, sleep hygiene, stimulus control.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Stress score in Kessler Distress Questionnaire and Yield Standard Questionnaire. Timepoint: Before the intervention and after the last intervention session. Method of measurement: Kessler Distress Questionnaire and Yield Standard Questionnaire.</prim_outcome>
      <prim_outcome>Anxiety score in Kessler Distress Questionnaire and Yield Standard Questionnaire. Timepoint: Before the intervention and after the last intervention session. Method of measurement: Kessler Distress Questionnaire and Yield Standard Questionnaire.</prim_outcome>
      <prim_outcome>Sleep quality score on the Pittsburgh questionnaire. Timepoint: Before the intervention and after the last intervention session. Method of measurement: Pittsburgh 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>University of social welfare and rehabilitation sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-10-20</approval_date>
        <contact_name>University of Rehabilitation Sciences and Social Health, Student Research Committe</contact_name>
        <contact_address>University of Science and Rehabilitation and Social Health, Koodakiar End, Daneshjoo Blvd. Evin Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
