<?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>IRCT201607297494N20</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-08-08</date_registration>
      <primary_sponsor>Vice Chancellor for Research Mazandaran University of Medical Sciences.</primary_sponsor>
      <public_title>The effect of self-selected calming music on pain intensity due to needle insertion in to a fistula in hemodialysis patients.</public_title>
      <acronym></acronym>
      <scientific_title>The effect of self-selected calming music on pain intensity due to needle insertion in to a fistula in hemodialysis patients.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-08-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>114</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/7971</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>pain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention of group 1: First in intervention group with music, pain degree due to needle insertion into an arteriovenous fistula will be recorded with visual measure immediately after needle insertion without any intervention. In the next session of hemodialysis, favorite song of every patient will be played by using headphone and mp4 player 6 minutes before needle insertion in to a fistula until the end of venopuncture and participants will be asked to entirely focus on music. Then one minute after the completion of venopuncture and fixing a needle, pain intensity due to neddle insertion in to a fistula will be recorded by visual analogue scale. Intervention 2: Other interventions&#13;
Intervention of group 2( headphone group): First in the intervention group with headphone during a session of hemodialysis, without any intervention, the pain degree due to needle insertion into a arteriovenous fistula will be recorded with visual measure immediately after needle insertion. In the next session of hemodialysis in this group, it will be used headphone without playing music 6 minutes before needle insertion into a fistula.  Then, one minute after the completion venopuncture and fixing needle insertion, pain intensity due to needle insertion into a fistula will be measured with visual analogue scale. Intervention 3: Control group: For control group based on ward’s routine, needle insertion in to a fistula will be done without any intervention. Then a minute after end of venopuncture and fixing needle, the pain degree due to needle insertion in to a fistula during 2 sessions of hemodialysis will be measured with visual analogue scale.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Masoumeh Bagheri- Nesami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>of Nursing &amp; Midwifery Mazandaran University of Medical Sciences, Sari, Iran.</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4816715793</zip>
        <telephone>+98 11 3336 7551</telephone>
        <email>anna3043@gmail.com</email>
        <affiliation>Mazandaran University of Medical Science</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Masumeh Bagheri Nesami</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing &amp; Midwifery Mazandaran University of Medical, Sciences, Sari, Iran</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4816715793</zip>
        <telephone>+98 11 3336 7551</telephone>
        <email>anna3043@gmail.com</email>
        <affiliation>Mazandaran University of Medical Science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: willing to listen to music; being 18 years or older; lack of neuropathic disorders; havingno known history of depression; being treated with hemodialysis for at least 3 months; not being administered analgesics and sedatives within 3 hours before needle insertion into a fistula; having no history of taking antipsychotic drugs; not being mentally impaired; having no visual and hearing dysfunction and not being habited to listen to music during hemodialysis. &#13;
Exclusion criteria: existence the acute pain in other area of body; need to try for needle insertion in to a fistula more than once; change in physical  condition; refusing to continue study and death.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R52.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>pain, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention of group 1: First in intervention group with music, pain degree due to needle insertion into an arteriovenous fistula will be recorded with visual measure immediately after needle insertion without any intervention. In the next session of hemodialysis, favorite song of every patient will be played by using headphone and mp4 player 6 minutes before needle insertion in to a fistula until the end of venopuncture and participants will be asked to entirely focus on music. Then one minute after the completion of venopuncture and fixing a needle, pain intensity due to neddle insertion in to a fistula will be recorded by visual analogue scale.</i_keyword>
      <i_keyword>Other interventions&#13;
Intervention of group 2( headphone group): First in the intervention group with headphone during a session of hemodialysis, without any intervention, the pain degree due to needle insertion into a arteriovenous fistula will be recorded with visual measure immediately after needle insertion. In the next session of hemodialysis in this group, it will be used headphone without playing music 6 minutes before needle insertion into a fistula.  Then, one minute after the completion venopuncture and fixing needle insertion, pain intensity due to needle insertion into a fistula will be measured with visual analogue scale.</i_keyword>
      <i_keyword>Control group: For control group based on ward’s routine, needle insertion in to a fistula will be done without any intervention. Then a minute after end of venopuncture and fixing needle, the pain degree due to needle insertion in to a fistula during 2 sessions of hemodialysis will be measured with visual analogue scale.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain. Timepoint: before and after intervention. Method of measurement: visual analoug 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>Vice Chancellor for Research Mazandaran University of Medical Sciences.</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-07-10</approval_date>
        <contact_name>Ethics Committee of Mazandaran University of Medical Science</contact_name>
        <contact_address>Sart of valiye asr highway, Imam Square, Sari, Mazandaran Sari  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
