<?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>IRCT20120910010800N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-10-01</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>The impact of listening to the Quran during general anesthesia on recovery outcomes following vitrectomy surgery.</public_title>
      <acronym></acronym>
      <scientific_title>The impact of listening to the Quran during general anesthesia on recovery outcomes following vitrectomy surgery.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/57300</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Basic scienece, Randomization description: Patients will be selected among individuals referring to the operating room of Imam Hossein (AS) hospital for vitrectomy surgery by simple randomization method using a coin toss. In such a way that the selection of the case is done in the case of heads and the selection of control is done in the case of tales, Blinding description: Before performing anesthesia, the anesthesia technician will select one of the audio files of the Quran (group Q) or white sound (group W) for the patient without the anesthesiologist's and the patient's awareness. After general anesthesia, headphones will be placed for all patients. The sound will be played for patients to such an extent that it will not be audible to others in the environment. The headphones will remain in place until the end of the surgery, and when the patient will wake up, the sound stops, and the headphones will be removed.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Vitrectomy surgery.</hc_freetext>
      <i_freetext>Intervention 1: Case group: After general anesthesia, headphones will be placed for all patients and the anesthesiologist will select the audio files of the Quran ("Surah Ma'idah" and "Surah Hamad") through headphones for the patient. The volume will be pre-checked using an audio sample for patient comfort and in any case will be set below 85 decibels (to prevent ear damage) according to the WHO recommendation. The headphones will remain in place until the end of surgery, and when the patient will begin to wake up, the sound will be stopped playing and the headphones removed. Intervention 2: Control group: The anesthesiologist will select the white sound (group W) for the patient. White sound is a type of sound that is produced by combining sounds with different frequencies. If you combine all the imaginable sounds that a human being can hear, a white sound will be created. The adjective white has been chosen to describe this type of sound because it has been used to describe white light. Various studies have used this sound to identify 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>009821277567840</telephone>
        <email>drdariushabtahi@yahoo.com</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>009812277567840</telephone>
        <email>drdariushabtahi@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Muslim
over than 18 years old
Consent to the study</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Impaired hearing
Drug abuse
Sedative drug use
Mental disorder</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>Case group: After general anesthesia, headphones will be placed for all patients and the anesthesiologist will select the audio files of the Quran ("Surah Ma'idah" and "Surah Hamad") through headphones for the patient. The volume will be pre-checked using an audio sample for patient comfort and in any case will be set below 85 decibels (to prevent ear damage) according to the WHO recommendation. The headphones will remain in place until the end of surgery, and when the patient will begin to wake up, the sound will be stopped playing and the headphones removed.</i_keyword>
      <i_keyword>Control group: The anesthesiologist will select the white sound (group W) for the patient. White sound is a type of sound that is produced by combining sounds with different frequencies. If you combine all the imaginable sounds that a human being can hear, a white sound will be created. The adjective white has been chosen to describe this type of sound because it has been used to describe white light. Various studies have used this sound to identify groups under music therapy as a control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Propofol consumption. 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>
    </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>2021-06-28</approval_date>
        <contact_name>Research Ethics Committees of Vice-Chancellor in Research Affairs - Shahid Beheshti University of Me</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>
