<?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>IRCT20231001059576N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-11-04</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The Effect of Music on Pain Intensity and Sleep Quality</public_title>
      <acronym></acronym>
      <scientific_title>Effect of Music Therapy on Pain Intensity and Sleep Quality of Patients with Multiple Sclerosis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-12-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/73177</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: The method of choosing the desired theme will be based on Schubert's articles regarding the feeling of musical steps. In this way, after selecting the desired Music determined by the researcher and a music expert, they will be placed in their desired theme group. The reason for choosing three types of happy, sad and invigorating themes is the effect of these themes on people's mood, which according to past research studies, happy themes are rhythmic pieces with a relatively sharp melody that bring vitality and vitality. It inspires excitement and impatience and is associated with stability and calm; Sad themes are sad and glorious and evoke sadness, failure, sorrow and regret in the listener. Sad themes by stimulating and associating memories and releasing sad feelings cause sympathy and relief. Invigorating themes, powerful rhythm and stimulating melodies with a positive and pleasant feeling give more energy and strength than what excites the spirit. These pieces, like a pleasant and pleasant shock, turn depression, laziness and lethargy into mobility and create a feeling of ability, mastery and determination. In general, the purpose of choosing the music was to start softly and end with hope and excitement after creating a sense of unity, Randomization description: The random sequence is generated by STATA software. Then this sequence is written on small cards and placed in the closed envelope. Every qualified person who entered the study, the door of the envelope is opened and based on the code on the card, he is placed in one of two groups. This method continues until all people are assigned to two groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Patients with Relapsing-Remitting Multiple Sclerosis who are in the Recovery Phase..</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patients with Multiple Sclerosis who will Receive Music Therapy in Addition to their Medications Prescribed by their Doctor. Music Therapy is Performed Three Times a Day for Two Weeks (Morning between 7 and 9, Evening between 4 and 6 and Night between 9 and 11) and each time for 10 to 15 Minutes During Waking hours. Or they will Rest and Listen to the Silent Music in Three Themes, Joyful, Sad and Invigorating, Composed by Iranian and Foreign Composers and Approved by Experts and Experts. Intervention 2: Control group: In this Group, They Will Take the Usual Treatment Interventions Prescribed by Their Doctor, And Music Therapy will not be Done for this group.</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 the data obtained from this research will be shared after completion.

When:
Access to the data will be possible 3 months after the results are published.

To whom:
These data will be used for researchers working in academic and scientific institutions, as well as for people with multiple sclerosis.

Conditions:
The data obtained from this research can be used in other scientific studies.

Where to obtain:
Copying (in any way) either from the full text or from the extracts is possible only with the coordination of the supervisor and the registered author and according to the instructions provided by the Central Library of Mashhad University of Medical Sciences. Details can be accessed through the relevant faculty library. The use of the thesis in articles or any scientific writing is subject to citing the source in compliance with the Mashhad University of Medical Sciences publishing regulations.
Hamid Reza Zendehtalab: ZendehtalabHR@mums.ac.ir
Milad Rezaei: Rezaeiml4001@mums.ac.ir

How to obtain:
The applicant should send an email to the responsible author and register his request. After verifying the correctness of the information of the mentioned person, the required content will be provided to him by mentioning the source.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hamid Reza Zendehtalab</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Educational Complex of Shahid Dr. Kharazmi, University Campus, East Gate of Ferdowsi University of Mashhad, Azadi Square, Mashhad, Khorasan Razavi</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9137913199</zip>
        <telephone>+98 51 3859 1511</telephone>
        <email>ZendehtalabHR@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Milad Rezaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 11, 7 Imam Khomeini Ave, Imam Khomeini Blvd</address>
        <city>Torbat-e Heydariyyeh</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9513643885</zip>
        <telephone>+98 51 5224 1503</telephone>
        <email>rezaeiml4001@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Refer to the Comprehensive Center for MS patients located in Qaem Hospital
Diagnosis of Multiple Sclerosis by a Specialist Doctor in the last year
Age between 20 and 50 Years
Patients with Relapsing-Remitting MS who are in the Recovery Phase of the Disease
Extended Disability Status Scale or EDSS between 0 and 5.5
Undesirable of Sleep Quality based on the Pittsburgh Sleep Quality (score above 5)
No addiction
Not Regularly Listening to a Particular Style of Music</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Unwillingness to Continue Participating in Research
Not listening to Music for 3 Nights in a Row or Alternately
Changing the Process of Disease Recurrence
Suffering from other Acute or Chronic Debilitating Diseases or Mental Disorders
Taking Sleeping Pills
The Presence of a Musician among those who live with the Patient under the Same Roof
Employment in the music profession</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>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Patients with Multiple Sclerosis who will Receive Music Therapy in Addition to their Medications Prescribed by their Doctor. Music Therapy is Performed Three Times a Day for Two Weeks (Morning between 7 and 9, Evening between 4 and 6 and Night between 9 and 11) and each time for 10 to 15 Minutes During Waking hours. Or they will Rest and Listen to the Silent Music in Three Themes, Joyful, Sad and Invigorating, Composed by Iranian and Foreign Composers and Approved by Experts and Experts.</i_keyword>
      <i_keyword>Control group: In this Group, They Will Take the Usual Treatment Interventions Prescribed by Their Doctor, And Music Therapy will not be Done for this group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain Intensity. Timepoint: Pain Intensity will be Measured in the Research Units Participating in the study at the Beginning of the Study (Before the Start of the Intervention) and 14 Days After the Start of the Intervention. Method of measurement: In this study, Pain Intensity will be Measured Using the McGill Pain Questionnaire.</prim_outcome>
      <prim_outcome>Sleep Quality. Timepoint: Pain Intensity will be Measured in the Research Units Participating in the study at the Beginning of the Study (Before the Start of the Intervention) and 14 Days After the Start of the Intervention. Method of measurement: In this study, Sleep Quality will be Measured Using the Pittsburgh Sleep Quality Index.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-10-17</approval_date>
        <contact_name>Ethics Committee of Faculty of Nursing and Midwifery - Mashhad University of Medical Sciences</contact_name>
        <contact_address>Educational Complex of Shahid Dr. Kharazmi, University Campus, east gate of Ferdowsi University of Mashhad, Azadi Square, Mashhad, Khorasan Razavi Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
