<?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>IRCT20231031059915N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-11-27</date_registration>
      <primary_sponsor>Bojnourd University of Medical Sciences</primary_sponsor>
      <public_title>The effect of the sleep health educational film on the sleep quality of the elderly.</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the impact of the sleep health educational film on the sleep quality of the elderly over 60 years old</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/73580</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: At the beginning of the study, the list of random codes will be prepared with the help of random number generator software in the form of permutation blocks. These codes are for randomly assigning the elderly included in the study to the intervention and control groups. The sampling method in this study is initially based on the goal and the research team will refer to the comprehensive health centers of Tabas city and select the people who meet the inclusion criteria from among the elderly who refer to those centers. In the following, the colleague of the research team will explain to them about the type of study, method and purpose of conducting the study. Then, based on the list of random codes prepared with the help of random number generator software in the form of replacement blocks, the people included in the study will be divided into intervention groups (35 people) and control groups (35 people) in the order specified in the list of random codes. This process will continue until the sample size (70 people) is completed.</study_design>
      <phase>N/A</phase>
      <hc_freetext>sleep quality.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: after assigning people to the intervention group, the prepared educational videos will be provided to them. These educational videos will contain the educational axes and objectives as follows: In the first session, gaining knowledge about the importance of sleep in old age and information about the physical characteristics of a suitable room for sleeping. In the second session, gaining knowledge and understanding about the dos and don'ts of a room suitable for sleeping. In the third session, gaining knowledge and understanding about setting a fixed sleep schedule and the necessity of restricting sleep during the day. In the fourth session, gaining knowledge and understanding about the effect of nutrition, activity and consumption of substances such as cigarettes, alcohol and hookah on sleep. Then, since based on a preliminary study that was done experimentally by the researchers, it was found that watching an educational film 4 times is a suitable number for the number of times of watching an educational film among the elderly; Therefore, the elderly will be asked to watch this educational video 4 times. Since at the end of the step-by-step training videos, assignments and tasks corresponding to the materials presented in each session are specified for people, seniors will be asked to do the assignments and tasks presented at the end of each session. Also, the researcher will contact the elderly members of the intervention group 1 or 2 times per week in order to ensure that the elderly use the educational videos, control and follow up on the tasks and assignments and answer the questions. Also, in necessary cases, the researcher will visit the elderly person's place of residence, control and follow up to ensure that the elderly person uses the educational video and carry out the recommendations and assignments. From the beginning of the second week, the elderly who are able to go in person to receive the educational CD will be requested to go to the designated comprehensive health center at the beginning of the second, third and fourth weeks to receive the CD related to the educational video of that week. Also, for the elderly who are not able to go in person to receive educational videos, CDs related to educational videos will be sent every week, and phone follow-up will be done to ensure that the videos reach the elderly. Seniors will also be asked to watch these educational videos in accordance with the recommendations given in the first week and do the assignments and tasks specified in them. Intervention 2: Control group: For people in the control group, routine measures will be provided, which includes the presentation of a pamphlet on the topic of sleep quality in the elderly. In this pamphlet, at first, the importance and changes of sleep during old age are discussed; In the following, 7 health tips for seniors' sleep are provided.</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 due to lack of clarity</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Ali Arghaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 26, Shahid Moradi Ave, Shahid Bahonar Blvd</address>
        <city>Tabas</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9791734855</zip>
        <telephone>+98 56 3282 8180</telephone>
        <email>ali.arghaei@yahoo.com</email>
        <affiliation>Bojnourd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Reza Armat</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sharyar St.</address>
        <city>Bojnourd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9678694176</zip>
        <telephone>+98 58 3229 7096</telephone>
        <email>rezaarmat@yahoo.com</email>
        <affiliation>Bojnourd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age above 60 years.
Enjoying vision, hearing, speech, and cognitive health (getting a score of 24 or more from the Short Cognitive Status Questionnaire (MMSE) in the literate elderly and getting a score of 7 or more from the Abbreviated Cognitive Status Questionnaire (AMT) in the illiterate elderly literacy).
Absence of depression, cancer, heart failure, severe lung disease, mental and physical disability, chronic pain and Alzheimer's based on the health records of the elderly
Not using herbal and chemical sedatives and hypnotics.
The ability to use educational videos based on questions from the elderly.</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Illness or hospitalization of the elderly during the intervention period.
Death of relatives and similar unexpected events during the intervention period.
No proper response for 2 weeks.</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>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: after assigning people to the intervention group, the prepared educational videos will be provided to them. These educational videos will contain the educational axes and objectives as follows: In the first session, gaining knowledge about the importance of sleep in old age and information about the physical characteristics of a suitable room for sleeping. In the second session, gaining knowledge and understanding about the dos and don'ts of a room suitable for sleeping. In the third session, gaining knowledge and understanding about setting a fixed sleep schedule and the necessity of restricting sleep during the day. In the fourth session, gaining knowledge and understanding about the effect of nutrition, activity and consumption of substances such as cigarettes, alcohol and hookah on sleep. Then, since based on a preliminary study that was done experimentally by the researchers, it was found that watching an educational film 4 times is a suitable number for the number of times of watching an educational film among the elderly; Therefore, the elderly will be asked to watch this educational video 4 times. Since at the end of the step-by-step training videos, assignments and tasks corresponding to the materials presented in each session are specified for people, seniors will be asked to do the assignments and tasks presented at the end of each session. Also, the researcher will contact the elderly members of the intervention group 1 or 2 times per week in order to ensure that the elderly use the educational videos, control and follow up on the tasks and assignments and answer the questions. Also, in necessary cases, the researcher will visit the elderly person's place of residence, control and follow up to ensure that the elderly person uses the educational video and carry out the recommendations and assignments. From the beginning of the second week, the elderly who are able to go in person to receive the educational CD will be requested to go to the designated comprehensive health center at the beginning of the second, third and fourth weeks to receive the CD related to the educational video of that week. Also, for the elderly who are not able to go in person to receive educational videos, CDs related to educational videos will be sent every week, and phone follow-up will be done to ensure that the videos reach the elderly. Seniors will also be asked to watch these educational videos in accordance with the recommendations given in the first week and do the assignments and tasks specified in them.</i_keyword>
      <i_keyword>Control group: For people in the control group, routine measures will be provided, which includes the presentation of a pamphlet on the topic of sleep quality in the elderly. In this pamphlet, at first, the importance and changes of sleep during old age are discussed; In the following, 7 health tips for seniors' sleep are provided.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sleep quality score obtained by completing the Petersburg Sleep Quality Questionnaire. Timepoint: The measurement sections will be done in 2 steps; At the beginning of the intervention and then at the end of the fifth week after the intervention. Method of measurement: Petersburg 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>Bojnourd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-09-17</approval_date>
        <contact_name>Ethics Committee of North Khorasan University of Medical Sciences.</contact_name>
        <contact_address>Research ethics committee, After Imam Ali Hospital, Shahryar St Bojnourd North Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
