<?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>IRCT20230607058413N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-07-20</date_registration>
      <primary_sponsor>Shahed University</primary_sponsor>
      <public_title>The effect of music and white noise on sleep quality, pain and anxiety</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Music and White Noise on the quality of sleep, pain and anxiety of the elderly  after surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-08-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>99</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70748</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Sampling is done after the visit of the patients by the surgeon, according to the available method, and the samples are allocated in the form of a random block of 6 without replacement in a ratio of 1:1 to three groups: white noise, music without words, and control.</study_design>
      <phase>N/A</phase>
      <hc_freetext>"Sleep quality", "Anxiety", "Pain".</hc_freetext>
      <i_freetext>Intervention group: 1- white music 2- silent music.</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:
Only data can be published

When:
2024

To whom:
General

Conditions:
If needed by people

Where to obtain:
Send a letter to the researcher's email

How to obtain:
After the applicant sends an email to the researcher, the requested file of this research will be sent within a maximum period of two weeks.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyyed Mostafa Bikaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 3, 2 Yusuftabar Alley, 24 Imam Khomeini St</address>
        <city>Babolsar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4741138589</zip>
        <telephone>+98 11 3533 0187</telephone>
        <email>mostafa.beikaie@shahed.ac.ir</email>
        <affiliation>Shahed University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyyed Mustafa Bikaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 3, 2 Yusuftabar Alley, 24 Imam Khomeini St</address>
        <city>babolsar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4741138589</zip>
        <telephone>009835330187</telephone>
        <email>mostafa.beikaie@shahed.ac.ir</email>
        <affiliation>Shahed University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age over 60 years
Ability to complete the questionnaire
Not having dementia with a score of more than 7 from the Abbreviated Mental Test Score (AMTS).
Good sleep quality with an overall score of less than 5 by the Pittsburgh Sleep Quality Scale
The surgery is not an emergency
Perform the operation under general anesthesia
No drug addiction
Not having hearing problems and exclusion criteria including hemodynamic instability, loss of consciousness and need for mechanical ventilation</inclusion_criteria>
      <agemin>60 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></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>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: 1- white music 2- silent music</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>"Sleep quality based on Richard Campbell's sleep quality questionnaire". Timepoint: "Night before surgery", "Morning before surgery", "First night after surgery", "Morning after surgery". Method of measurement: "Richard Campbell Sleep Quality Questionnaire".</prim_outcome>
      <prim_outcome>"Anxiety level based on the anxiety measurement questionnaire". Timepoint: "The night before surgery". Method of measurement: "Spielberger Questionnaire".</prim_outcome>
      <prim_outcome>"Pain level based on visual pain scale". Timepoint: "One hour after surgery". Method of measurement: "Visual Pain Scale".</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>"Blood pressure". Timepoint: The night before surgery, one hour after surgery. Method of measurement: "Blood pressure device".</sec_outcome>
      <sec_outcome>"Blood oxygen saturation level". Timepoint: One hour after surgery. Method of measurement: "Pulse oximetry".</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>Shahed University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-06-19</approval_date>
        <contact_name>Bioethics Committee of Shahed University</contact_name>
        <contact_address>The north side of Aftab city fair, next to the Persian Gulf highway tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
