<?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>IRCT20110906007494N42</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-11-10</date_registration>
      <primary_sponsor>Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of music therapy on pain and anxiety</public_title>
      <acronym></acronym>
      <scientific_title>The effect of music therapy on pain and anxiety of patients undergoing wound healing with suturing techniques in  emergency departments</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-11-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/59108</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Blocking method will be used for random allocation of samples. For this purpose, quadruple blocks will be considered. The six possible blocks are TTCC, TCTC, TCCT, CCTT, CTCT, CTTC, where T is for the intervention group and C is for the control group. The numbers will be generated randomly (with the RANDBETWEEN command in Excel software and in the range 1 to 6) and selected according to the production values ​​of one of the blocks (for the production number 1 CTTC block, for the production number 2 CTCT blocks and so on) and sample Will be allocated.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Wound healing.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Traditional Iranian non-verbal music is played from the time the patient is placed on the bed, for washing and stitching until the end.Pain is measured by Visual Analogue Scale. Pain is measured in two stages before the intervention and after anesthesia injection Taken. Anxiety is measured with Faces Anxiety Scale in three stages before the intervention, after anesthesia injection, and after suturing.Traditional Iranian non-verbal music, a piece of the morning courier composed by Homayoun Khoram and played by Babak Shahraki, is played to the patient with the help of headphones. The method of performing this song is three playing with dulcimer, violin and tombak and its duration is 1 minute and 54 seconds. This song is recorded for 20 minutes in a row so that there is no gap in its playing during wound healing and until the end of healing. to be continued. Its sedation was determined by MT30 at a rate of 76 beats. Due to the fact that the beat is between 60 and 80, this music is soothing, the song will be recorded on a memory card and played with SONY brand headphones. Intervention 2: Control group: In the control group, patients will be stitched as usual and no music will be played for them and for them, music will not be played and the pain will be measured in the same two stages, ie after the patient is placed on the bed and after the wound is washed and the anesthetic is injected. Anxiety will be measured in three stages, first after the patient is placed on the bed, second after washing and anesthesia injection, and third after suturing.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is En There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr.Masoumeh Bagheri Nesami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mazandaran University of Medical Sciences, Imam Square, Highway Bassij, 3-way Jouibar, Sari</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4816715793</zip>
        <telephone>+98 11 3379 5508</telephone>
        <email>hedayatijavad5@gmail.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Masoumeh Bagheri Nesami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>sari,joybar three ways,mazandaran university of medical scinces</address>
        <city>sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4816715793</zip>
        <telephone>+98 11 3379 5508</telephone>
        <email>ann3043@gmail.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Satisfaction with participation in the study.
Rupture 5 cm or less in limbs that require sutures.
Being 18-65 years old.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The patient does not cooperate during the process for any reason.
The researcher will not be able to intervene during the procedure according to the patient's condition.
Mental, auditory, speech, physical and motor disabilities and paralysis of the limbs.
Receiving anti-anxiety medications.
Take painkillers for 12 hours before the study.
Having tears that involve the tendons and ligaments.
Severe psychiatric disorders and medication.
Getting Cancer.
Rheumatic disease and drug treatment.
Existence of rupture due to self-mutilation.
Existence of multiple tears and simultaneous damage to other organs.
Opioid addiction.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Y74.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Surgical instruments, materials and general hospital and personal-use devices (including sutures) associated with adverse incidents</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Traditional Iranian non-verbal music is played from the time the patient is placed on the bed, for washing and stitching until the end.Pain is measured by Visual Analogue Scale. Pain is measured in two stages before the intervention and after anesthesia injection Taken. Anxiety is measured with Faces Anxiety Scale in three stages before the intervention, after anesthesia injection, and after suturing.Traditional Iranian non-verbal music, a piece of the morning courier composed by Homayoun Khoram and played by Babak Shahraki, is played to the patient with the help of headphones. The method of performing this song is three playing with dulcimer, violin and tombak and its duration is 1 minute and 54 seconds. This song is recorded for 20 minutes in a row so that there is no gap in its playing during wound healing and until the end of healing. to be continued. Its sedation was determined by MT30 at a rate of 76 beats. Due to the fact that the beat is between 60 and 80, this music is soothing, the song will be recorded on a memory card and played with SONY brand headphones.</i_keyword>
      <i_keyword>Control group: In the control group, patients will be stitched as usual and no music will be played for them and for them, music will not be played and the pain will be measured in the same two stages, ie after the patient is placed on the bed and after the wound is washed and the anesthetic is injected. Anxiety will be measured in three stages, first after the patient is placed on the bed, second after washing and anesthesia injection, and third after suturing.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: For the intervention and control groups once after bed rest and the second time after washing and anesthesia injection. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>Anxiety disorders. Timepoint: For the intervention and control groups once after bed rest, the second after washing and injecting anesthesia, and the third after suturing. Method of measurement: facial anxiety scale.</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>Mazandaran Mideacal Science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-10-12</approval_date>
        <contact_name>Ethics Committee of Mazandaran University of Medical Sciences</contact_name>
        <contact_address>Mazandaran University of Medical Sciences, Vice chancellor for research, Moalem street,Moalem square sari Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-10-12</approval_date>
        <contact_name>Ethics Committee of Mazandaran University of Medical Sciences</contact_name>
        <contact_address>Mazandaran University of Medical Sciences, Vice chancellor for research, Moalem street,Moalem square sari Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
