<?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>IRCT20201207049634N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-11-28</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of rehabilitation nursing intervention on the health of patients with hand burns</public_title>
      <acronym></acronym>
      <scientific_title>The effect of rehabilitation nursing intervention model on the comprehensive health and daily performance of patients with hand burns</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/52859</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The method of allocating samples in groups is in the form of four random blocks without permutation. The letter A for the control group and the letter B are considered for the test group. Different modes of two groups (ABBA-BABA-ABAB-BAAB-BBAA-AABB) are written on six cards. Each card is placed in a sealed envelope. These envelopes are placed in a box and the researcher does not know in which group the research units will be located until the card is selected. A person who is not aware of the study and the groups, by selecting one of the envelopes from the box, determines in which group the patients will be located. This process is continued until all six cards are taken out of the box and the cards are returned to the box and this random selection is repeated to provide the desired sample size.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Hand burns.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Patients in the intervention group, in addition to routine hospital treatment-rehabilitation programs, receive a rehabilitation nursing model in 3 stages: 1- Acute stage: social support, health education, psychological counseling and passive hand movements. 2- Recovery stage: psychological counseling, treatment. Rational-emotional and active hand exercises. 3- Post-discharge stage: 1- Talk about re-employment and intellectual-emotional support. Intervention 2: Control group: Patients in the control group receive only routine nursing care for 5 weeks.</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:
Part of the data on the primary outcome is for sharing

When:
One year after the publication the data will be available.

To whom:
Researchers working in academic and scientific institutions

Conditions:
Meta-analysis is allowed on the data of this study.

Where to obtain:
Ms,Mahnaz Seyedoshohadaee, Faculty of Nursing and Midwifery of Iran University of Medical Sciences, Rashid yasemi St., above Mirdamad, Vali Asr St., Tehran, Iran , Email: seyedoshohadaee.m@iums.ac.ir

How to obtain:
After one year of publishing the article and publishing the results, those who need the data of this study, could apply via email.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahnaz Seyedoshohadaee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery of Iran University of Medical Sciences, Rashid yasemi St., above Mirdamad, Vali Asr St., Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>19967-13883</zip>
        <telephone>+98 21 8888 2885</telephone>
        <email>seyedoshohadaee.m@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahnaz Seyedoshohadaee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Nursing and Midwifery of Iran University of Medical Sciences, Rashid yasemi St., above Mirdamad, Vali Asr St., Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>19967-13883</zip>
        <telephone>+98 21 8888 2885</telephone>
        <email>seyedoshohadaee.m@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>hand burns
Deep burns
Age over 18 years
No history of mental illness
Interested to participate in the study
Being literate</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Serious damage to the muscles of the upper limbs, tendons, skeletons and nerves
Patients with severe heart disease who were unconscious before the burn
Patients with heart, lung, and brain diseases
Unwillingness to participate in the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M61.34</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Calcification and ossification of muscles associated with burns, hand</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Patients in the intervention group, in addition to routine hospital treatment-rehabilitation programs, receive a rehabilitation nursing model in 3 stages: 1- Acute stage: social support, health education, psychological counseling and passive hand movements. 2- Recovery stage: psychological counseling, treatment. Rational-emotional and active hand exercises. 3- Post-discharge stage: 1- Talk about re-employment and intellectual-emotional support.</i_keyword>
      <i_keyword>Control group: Patients in the control group receive only routine nursing care for 5 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The quality of life in patients with hand burn. Timepoint: At the time of admission, recovery and post discharge from the hospital. Method of measurement: Quality of life questionnaire for burn patients: This questionnaire includes 40 questions in the areas of skin sensitivity to heat, body image, hand function, how to care for burned areas, job-communication, ability to perform simple activities, sexual function and emotional dimension and It has a 5-point Likert scale (severe, high, medium, low and not at all) that scaled from one to five and each question has the minimum score of 1 and the maximum of 5 . Out of 40 questionnaire questions, 18 questions are related to the physical dimension of quality of life, 11 questions are related to the psychological dimension of quality of life and 11 questions are related to the social dimension of quality of life. The quality of life is assessed for each dimension separately and also in all dimensions. The quality of life is based on the scores' average, the higher the mean, the better the quality of life and the lower mean represents lower quality of life.</prim_outcome>
      <prim_outcome>Activities of Daily Living. Timepoint: At the time of admission; recovery: the first four weeks (once a week); post discharge from the hospital: six months post discharge (once a month). Method of measurement: The Lawton Instrumental Activities of Daily Living Scale (IADL).</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-10-27</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Faculty of Nursing and Midwifery of Iran University of Medical Sciences, Rashid Yasemi St., above Mirdamad, Vali Asr St., Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
