<?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>IRCT20210612051551N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-11-10</date_registration>
      <primary_sponsor>Esfahan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of using soundproof headphone on patients' physiological indices and duration of recovery</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effect of using sound proof headphones during orthopedic surgery with spinal anesthesia on patients' physiological indices and length of staying in recovery room: a controlled clinical trial in selected hospitals of Isfahan in 2021</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-11-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>184</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/56896</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Blinding description: Person who analyzes data doesn't know that which data belong to which group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Orthopedic surgeries with spinal anesthesia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: using Hellberg secure 2 soundproof headphone to reduce hearing noises in patients with spinal anesthesia. the headphone will be placed on patient's ears after inducing of spinal anesthesia and it will be removed at the end of surgery when suturing is done. then we will monitor patient's physiologic indices in 5 points and also we will measure length of staying in recovery room. Intervention 2: Control group: soundproof headphone won't be used for patients  in control group and usual surgery will be done for patients.</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 including data related to main variables like "length of staying in recovery room" and " mean of physiologic indices" and also background variables like kind of surgery, age and sex of patients will be published after unrecognizing patients.

When:
Six months after gathering results

To whom:
Researchers working in universities will get access to data.

Conditions:
Using data for :
1.Therapeutic goals
2. research goals

Where to obtain:
Saeed Belyad
0098 937 2580188

How to obtain:
Sending a request by calling and providing evidence for use in research or treatment and receiving data in less than a week

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Saeed Belyad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Keshavarzi Blvd., Keshavarzi Sq. Kosar dormitory</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4183634819</zip>
        <telephone>+98 13 3336 0483</telephone>
        <email>saeedbelyad76@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Akram Arabi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hezarjerib Ave</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4183634819</zip>
        <telephone>+98 13 3336 0483</telephone>
        <email>Aarabi@nm.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients who are aged between 18-65 years
Surgeries that last less than 2 hours
Surgeries except amputation
Patients without mental illness
Having normal hearing</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Surgeries except orthopedic surgeries
Patients with general anesthesia
Patients with emergency conditions</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>Diagnosis</i_code>
      <i_code>Diagnosis</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: using Hellberg secure 2 soundproof headphone to reduce hearing noises in patients with spinal anesthesia. the headphone will be placed on patient's ears after inducing of spinal anesthesia and it will be removed at the end of surgery when suturing is done. then we will monitor patient's physiologic indices in 5 points and also we will measure length of staying in recovery room.</i_keyword>
      <i_keyword>Control group: soundproof headphone won't be used for patients  in control group and usual surgery will be done for patients.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Duration of staying in recovery room. Timepoint: When patients enter to the recovery room and when patients leave it. Method of measurement: Record time in checklist.</prim_outcome>
      <prim_outcome>Systolic  blood pressure. Timepoint: Before surgery, before entering recovery room, after entering recovery room, 15 minutes after entering recovery room, 30 minutes after entering recovery room. Method of measurement: Record in checklist.</prim_outcome>
      <prim_outcome>Diastolic blood pressure. Timepoint: Before surgery, before entering recovery room, after entering recovery room, 15 minutes after entering recovery room, 30 minutes after entering recovery room. Method of measurement: Record in checklist.</prim_outcome>
      <prim_outcome>Heart rate. Timepoint: Before surgery, before entering recovery room, after entering recovery room, 15 minutes after entering recovery room, 30 minutes after entering recovery room. Method of measurement: Record in checklist.</prim_outcome>
      <prim_outcome>Respiratory rate. Timepoint: Before surgery, before entering recovery room, after entering recovery room, 15 minutes after entering recovery room, 30 minutes after entering recovery room. Method of measurement: Record in checklist.</prim_outcome>
      <prim_outcome>Oxygen saturation. Timepoint: Before surgery, before entering recovery room, after entering recovery room, 15 minutes after entering recovery room, 30 minutes after entering recovery room. Method of measurement: Record in checklist.</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>Esfahan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-08-10</approval_date>
        <contact_name>Ethics committee of Isfahan University of Medical Sciences</contact_name>
        <contact_address>Hezar Jerib Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
