<?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>IRCT20210613051567N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-08-19</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the effect of virtual glasses on children's pain intensity and parental satisfaction</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of using virtual reality glasses on children's pain intensity and parents' satisfaction of pain management during suturing</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-08-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/56920</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: Use virtual glasses to play 3D educational animation, Randomization description: In this study, the samples are divided into simple and individual randomizations and first, on 60 pieces of paper, the number 1 was written as a sign of the intervention group or 2 as a sign of the control group. The papers were packed in small envelopes that looked exactly like each other, placed in a box, and when each child entered the ward, each child randomly selected one of the envelopes in the box and according to selected number 1 or 2 was placed in the intervention or control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Severe pain when the limb is sutured.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: initially, pain intensity in the intervention group will be measured and compared using the instrument (VAS) before the intervention.  In the intervention group, before entering the suture room, the correct use of glasses will be fully explained to children and parents, and then virtual glasses will be used 1 to 3 minutes before the start of the suturing procedure.  A 5-minute animation in which the method of suturing by the medical staff, which also has an educational aspect and is made by a researcher, will be broadcast in 5 minutes as a game and animation for the child, and if the animation is completed and the procedure continues (which  Usually lasts 5 to 10 minutes), the animation will be repeated and after the stitches are done, the glasses will be removed from the child's eyes and the severity of the child's pain will be measured.  After suturing in the intervention group, it will be measured using a pain intensity test (Visual Analogue Scale). During the whole suturing work, one of the parents will be present with the child in the intervention group.  All parents 'satisfaction will be measured using the Parents' Satisfaction Questionnaire for pain management half an hour after the intervention and suturing.  Demographic information will also be asked of parents at the beginning of the sampling. Intervention 2: Control group: 30 children will be randomly selected in the control group and the routine of the hospital will be performed for them and lidocaine will be used for anesthesia, but virtual glasses will not be used. After suturing the pain questionnaires (VAS) and parents' satisfaction with pain management, the child and parents will be given to collect data.</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:
Data are collected through two questionnaires of VAS and parental satisfaction with pain management and the results of the data are analyzed by skilled people and the pain is at the discretion of professors and treatment staff to use its beneficial results.

When:
After collecting the samples and analyzing them by statistical software, it will be possible to access the data results. The obtained data is also available during sampling

To whom:
Researchers, professors, consultants, supervisors, and treatment staff at the sampling site are allowed to access the data

Conditions:
In order to improve the performance of the treatment staff and reduce stress and stress and pain of children and their families and in the conditions of achieving the expected results, the data can be used.

Where to obtain:
To receive the documents and data after analyzing them, refer to the researcher or Tehran University of Medical Sciences

How to obtain:
To receive documents and data, the applicant can access the data by email to the researcher or by referring to Tehran University of Medical Sciences and learning the researcher's dissertation.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahya Farmani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and Midwifery school of Tehran University Of Medical Science. Mirkhani Street, Towhid Square</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6692 7171</telephone>
        <email>Mahyafarmanii@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahya Farmani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nursing and Midwifery school of Tehran University Of Medical Science. Mirkhani Street, Towhid Square</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733171</zip>
        <telephone>+98 21 6692 7171</telephone>
        <email>Mahyafarmanii@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The child should be sutured to the limbs and body and referred to Rajai Hospital
Age: 5 to 7 years old
No pain or other problem other than the pain of amputation
Ability to communicate
No vision or hearing problems (based on initial history)
No psychological problems or mental retardation (based on initial history)
Do not use oral or injectable analgesics before entering the hospital</inclusion_criteria>
      <agemin>5 years</agemin>
      <agemax>7 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Any child who did not cooperate in the study (for example, refrained from wearing glasses or repeatedly removed glasses from their eyes while suturing)
Parents who do not answer the research questions correctly.
The need to use oral analgesics between suturing procedures.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G89.21</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic pain due to</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: initially, pain intensity in the intervention group will be measured and compared using the instrument (VAS) before the intervention.  In the intervention group, before entering the suture room, the correct use of glasses will be fully explained to children and parents, and then virtual glasses will be used 1 to 3 minutes before the start of the suturing procedure.  A 5-minute animation in which the method of suturing by the medical staff, which also has an educational aspect and is made by a researcher, will be broadcast in 5 minutes as a game and animation for the child, and if the animation is completed and the procedure continues (which  Usually lasts 5 to 10 minutes), the animation will be repeated and after the stitches are done, the glasses will be removed from the child's eyes and the severity of the child's pain will be measured.  After suturing in the intervention group, it will be measured using a pain intensity test (Visual Analogue Scale). During the whole suturing work, one of the parents will be present with the child in the intervention group.  All parents 'satisfaction will be measured using the Parents' Satisfaction Questionnaire for pain management half an hour after the intervention and suturing.  Demographic information will also be asked of parents at the beginning of the sampling.</i_keyword>
      <i_keyword>Control group: 30 children will be randomly selected in the control group and the routine of the hospital will be performed for them and lidocaine will be used for anesthesia, but virtual glasses will not be used. After suturing the pain questionnaires (VAS) and parents' satisfaction with pain management, the child and parents will be given to collect data.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain intensity during suturing and parental satisfaction with pain management. Timepoint: Pain intensity is measured half an hour before and immediately after suturing. Method of measurement: VAS pain measurement tool VAS and satisfaction is measured by a researcher-made questionnaire.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-05-31</approval_date>
        <contact_name>Ethics committee of tehran University of Medical Sciences</contact_name>
        <contact_address>Nursing and Midwifery School of Tehran University of Medical Science; Mirkhani Street; Towhid Square, Tehran Town Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
