<?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>IRCT20120910010800N6</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-10-02</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Effect of music during general anesthesia on propofol consumption during vitrectomy surgery.</public_title>
      <acronym></acronym>
      <scientific_title>Evaluating the effectiveness of listening to classical music during general anesthesia compared to white noise in reducing propofol consumption during vitrectomy surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-10-07</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/59935</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients are divided into two intervention and control groups using six blocks of four in permutation blocks, and this process will be continued until all research participants have been enrolled. When the patient enters the operating room, the anesthesia technician performs this task and plays the audio player file that corresponds to the patient's group. Until the patient exits the operating room, the patient group won't be identifiable to anybody else, Blinding description: Before performing anesthesia, an anesthesiologist will select the patient group using colored cards without the knowledge of the anesthesiologist, surgeon, and patient. After the induction of general anesthesia, headphones will be placed on the patient and the same technician will play the appropriate file for the group. The sound played for the patient will be at a level that cannot be heard by others. The headphones remain in place until the end of the surgery, and when the patient wakes up, the sound is stopped and then the headphones are removed. Until the questionnaire information is completed and the patient is removed from the operating room, no one except the technician will be aware of the patient's group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Vitrectomy Surgery.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: After general anesthesia, a headphone is placed on the patient and the classical music file is played through it. The loudness of the sound is checked in advance using a sound sample for the comfort of the patient and is set below 85 dB (to prevent ear damage) based on the recommendation of the World Health Organization. The headphones remain in place until the end of the surgery. When the patient starts to wake up, the sound is stopped and the headphones are removed. Intervention 2: Control group: the white noise file is played for the patient. White noise is a type of sound that is created by combining sounds with different frequencies. If you combine all the imaginable sounds that a human can hear, white noise will be created. The adjective white has been chosen to describe this type of sound for the same reason that it is used to describe white light. Various studies use this sound to compare groups under music therapy as a control 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 data is potentially shareable after unidentified individuals.

When:
One year after the publication of the article

To whom:
All jobs

Conditions:
All non-personal patient information (anonymously) can be accessed by contacting the responsible author.

Where to obtain:
email to: drdariushabtahi@yahoo.com

How to obtain:
Sending email and review by the responsible author.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dariush Abtahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Emam Hossein Hospital, Shahid Madani St</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1617763141</zip>
        <telephone>+98 21 2263 2611</telephone>
        <email>d.abtahi@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dariush Abtahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Emam Hossein Hospital, Shahid Madani St</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1617763141</zip>
        <telephone>+98 21 2263 2611</telephone>
        <email>d.abtahi@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>American Society of Anesthesiologists (ASA) Physical Status Classification System I and II
vitrectomy surgery
Age above 18 years
Consent to study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>hearing impairment
mental health problem
prolonged use of sedatives or analgesics
alcoholism or other illicit drug addiction</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z98.89</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other specified postprocedural states</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: After general anesthesia, a headphone is placed on the patient and the classical music file is played through it. The loudness of the sound is checked in advance using a sound sample for the comfort of the patient and is set below 85 dB (to prevent ear damage) based on the recommendation of the World Health Organization. The headphones remain in place until the end of the surgery. When the patient starts to wake up, the sound is stopped and the headphones are removed.</i_keyword>
      <i_keyword>Control group: the white noise file is played for the patient. White noise is a type of sound that is created by combining sounds with different frequencies. If you combine all the imaginable sounds that a human can hear, white noise will be created. The adjective white has been chosen to describe this type of sound for the same reason that it is used to describe white light. Various studies use this sound to compare groups under music therapy as a control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Propofol consumption level. Timepoint: End of surgery. Method of measurement: A standard anesthesia sheet is used in the patient file to determine the total amount of propofol used in mg. The patient's propofol consumption at the beginning of anesthesia and then it is recorded in the file as standard and at the end the total amount is added together.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Post-operative nausea and vomiting. Timepoint: In recovery room. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Blood pressure. Timepoint: During and after the surgery. Method of measurement: Monitoring device.</sec_outcome>
      <sec_outcome>Heart rate. Timepoint: During and after the surgery. Method of measurement: Monitoring device.</sec_outcome>
      <sec_outcome>Bispectral index. Timepoint: During surgery. Method of measurement: Bispectral index device.</sec_outcome>
      <sec_outcome>Pain. Timepoint: After surgery. Method of measurement: Using visual analog scale.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-07-24</approval_date>
        <contact_name>Research Ethics Committees of Shahid Beheshti University of Medical Science</contact_name>
        <contact_address>Emam Hossein Hospital, Shahid Madani St. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
