<?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>IRCT20211023052853N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-11-16</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>the effects  of Sleep hygiene education and music  on sleep quality in clients with MS</public_title>
      <acronym></acronym>
      <scientific_title>Evaluate the effects  of Sleep hygiene education and music therapy on sleep quality in clients with multiple sclerosis (MS)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/59627</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Multiple Sclerosis (MS).</hc_freetext>
      <i_freetext>Intervention group: To conduct this research, which is a one-group quasi-experimental study with pre-test-post-test, the researcher after obtaining permission from the ethics committee and obtaining permission to conduct research from Iran University of Medical Sciences due to corona pandemic in full compliance with protocols Behdashti refers to the research environment, which is the Iranian Inflammatory Association, and after coordinating with the relevant officials in the Inflammatory Association and obtaining permission from them in that center, the research objectives will be fully explained to them, and If they wish to participate in the research, the informed consent form will be completed by them. Selects those who have the criteria to enter the research in a continuous manner, which is based on the statistical formula of 50 people. After reaching the sample size due to the corona pandemic, training of the samples is done in a suitable space by observing the distance and health protocols in person. Due to the large number of samples for better teaching and learning and observing the social distance, the samples are divided into four groups and training of these four groups is done in one day but at different hours. Coordination with the samples is done for the date and time of the training session. After the pre-test session, which includes two questionnaires: 1- Demographic information and 2- Pittsburgh questionnaire, it is completed in person at the Emas Association. The time allotted for filling out this questionnaire is 5-10 minutes. Then, after collecting questionnaires about sleep hygiene and how to use music, the necessary training in person, which includes lying down in a comfortable position and closing your eyes before listening to non-verbal and soothing music and focusing on it. The mental opinion that is accompanied by the sound of nature should be mentioned. It should be mentioned that music is without words and only the sound of nature and has a license from the Ministry of Guidance. 30 minutes before bedtime is given without headphones. Also, explanations about sleep hygiene are provided in person. Before going to bed, use the bed only for sleep and sex, do not take a nap during the day, take a shower, do not watch the clock, exercise, eat a healthy and balanced diet, a good atmosphere, maintain a daily schedule. The instructional booklet and music without words will be provided to the samples. In addition, the researcher's contact phone will be provided to the samples to remove any ambiguity and questions, so that the researcher can follow up by phone to control the condition of the samples. Post-test intervention will be filled electronically by the sample due to the prevalence of coronary pandemic. After collecting the questionnaires, data and scores related to each section of the questionnaire are calculated..</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:
All potential data can be shared after unidentified individuals

When:
The data can be published after the publication of the article

To whom:
There are no restrictions on access

Conditions:
It can be used in secondary studies and for researchers

Where to obtain:
The information will be available as a file attached to the article

How to obtain:
By search

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>ّّFatemeh Sadeghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 7,No. 2,  Dariush Dead End, Shabboo Alley, Besarati St, Shahin shomali  َAve , Janatabad</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1475775931</zip>
        <telephone>+98 21 4613 8509</telephone>
        <email>fatemeh.sadeghi.1393@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh Sadeghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 7, No. 2, Dariush Dead End, Shabboo Alley, Besarati St, Shahin shomali Ave, Janatabad</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1475775931</zip>
        <telephone>+98 21 4613 8509</telephone>
        <email>fatemeh.sadeghi.1393@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having a smart phone with the ability to play music and have a social network and the ability to use it
Literate
No hearing impairment
PSQI score greater than five
Ages between 20 to 40 years
Absence of relapse and exacerbation of symptoms
No communication and cognitive problems (with patient comments and records)
Absence of patients other than multiple sclerosis</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Known serious physical-mental illness
Participate in programs or treatments that affect sleep</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G35</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Multiple sclerosis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: To conduct this research, which is a one-group quasi-experimental study with pre-test-post-test, the researcher after obtaining permission from the ethics committee and obtaining permission to conduct research from Iran University of Medical Sciences due to corona pandemic in full compliance with protocols Behdashti refers to the research environment, which is the Iranian Inflammatory Association, and after coordinating with the relevant officials in the Inflammatory Association and obtaining permission from them in that center, the research objectives will be fully explained to them, and If they wish to participate in the research, the informed consent form will be completed by them. Selects those who have the criteria to enter the research in a continuous manner, which is based on the statistical formula of 50 people. After reaching the sample size due to the corona pandemic, training of the samples is done in a suitable space by observing the distance and health protocols in person. Due to the large number of samples for better teaching and learning and observing the social distance, the samples are divided into four groups and training of these four groups is done in one day but at different hours. Coordination with the samples is done for the date and time of the training session. After the pre-test session, which includes two questionnaires: 1- Demographic information and 2- Pittsburgh questionnaire, it is completed in person at the Emas Association. The time allotted for filling out this questionnaire is 5-10 minutes. Then, after collecting questionnaires about sleep hygiene and how to use music, the necessary training in person, which includes lying down in a comfortable position and closing your eyes before listening to non-verbal and soothing music and focusing on it. The mental opinion that is accompanied by the sound of nature should be mentioned. It should be mentioned that music is without words and only the sound of nature and has a license from the Ministry of Guidance. 30 minutes before bedtime is given without headphones. Also, explanations about sleep hygiene are provided in person. Before going to bed, use the bed only for sleep and sex, do not take a nap during the day, take a shower, do not watch the clock, exercise, eat a healthy and balanced diet, a good atmosphere, maintain a daily schedule. The instructional booklet and music without words will be provided to the samples. In addition, the researcher's contact phone will be provided to the samples to remove any ambiguity and questions, so that the researcher can follow up by phone to control the condition of the samples. Post-test intervention will be filled electronically by the sample due to the prevalence of coronary pandemic. After collecting the questionnaires, data and scores related to each section of the questionnaire are calculated.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sleep quality score on the Pittsburgh questionnaire. Timepoint: Before the intervention and 14 days after the intervention. 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></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-10-26</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Unit 7, No. 2,Dariush Dead End, Shabboo Alley, Besarati St, Shahin Shomali Ave, Janatabad Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
