<?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>IRCT20221231056998N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-04-25</date_registration>
      <primary_sponsor>Bagheiat-allah University of Medical Sciences</primary_sponsor>
      <public_title>"Effectiveness of respiratory care training on sleep quality of children with neuromuscular disease (NMD)"</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of respiratory care training on sleep quality of children with neuromuscular disease (NMD) and the stress of their parents</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-12-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69101</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Children were selected by available sampling method and finally, each of the selected samples will be assigned to the control or intervention group with Random Allocation Software (RAS).
In the main window of the program, the number of groups (2 groups), the sample size (44) and the name of each group (intervention group and control group) will be specified.
Then, in the settings section, the randomization option will be set with the same blocks, and by clicking the generate option, the sequence will appear in the form of several columns, which indicate which group each sample should be assigned to, Blinding description: I will do the analysis by coding the data and anonymizing the questionnaire.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Neuromuscular diseases.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: For the parents and children of the intervention group, airway clearing training and breathing exercises will be carried out in the form of a care training program that includes effective breathing methods, exercises to increase the strength of the respiratory muscles, abdominal breathing training, specialized care in removing airway secretions, Effective cough, postural drainage and suction of secretions, proper position and ways of oxygen therapy, mouthwash and cardiopulmonary resuscitation will be effective. This training course will include 4 sessions of 75 minutes during a period of two weeks (two training sessions per week) of webinar training with the participation of parents on social networks.Also, educational content prepared for parents in the form of audio recording, as well as webinar video and pdf file will be shared on social networks for parents. Intervention 2: Control group: The control group will receive the usual parental care that the parents have already been trained to take care of their children's breathing, and the questionnaires will be completed at the beginning and two weeks after the end of the intervention.  The educational content will be provided to the control group after the completion of the research.</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 Due to the confidentiality of the data of military families, it is not possible to publish it</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Malihe Sadat Moayed</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sheikh bahaee</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8344117875</zip>
        <telephone>+98 21 8755 5503</telephone>
        <email>msmoayed@bmsu.ac.ir</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Malihe Sadat Moayed</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sheikh bahaee</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8344117875</zip>
        <telephone>+98 21 8755 5503</telephone>
        <email>msmoayed@bmsu.ac.ir</email>
        <affiliation>Bagheiat-allah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Children with neuromuscular diseases who do not have a good quality of sleep based on the score of the questionnaire.
Do not take specific medicine for insomnia problems.
The ability of parents to participate in webinars
The child's family has the desire and consent to participate in the study.
The parents do not have a mood disorder (not taking medication and not experiencing other stressful conditions outside of the child's hospitalization during the child's hospitalization)</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>18 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Incomplete participation of parents in filling out questionnaires or participating in meetings
Dissatisfaction and unwillingness of the child's family to continue working with the researcher
Death of a child
Having more than one child with NMD disease
Having more than one child with NMD disease</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G71.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Muscular dystrophy</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: For the parents and children of the intervention group, airway clearing training and breathing exercises will be carried out in the form of a care training program that includes effective breathing methods, exercises to increase the strength of the respiratory muscles, abdominal breathing training, specialized care in removing airway secretions, Effective cough, postural drainage and suction of secretions, proper position and ways of oxygen therapy, mouthwash and cardiopulmonary resuscitation will be effective. This training course will include 4 sessions of 75 minutes during a period of two weeks (two training sessions per week) of webinar training with the participation of parents on social networks.Also, educational content prepared for parents in the form of audio recording, as well as webinar video and pdf file will be shared on social networks for parents.</i_keyword>
      <i_keyword>Control group: The control group will receive the usual parental care that the parents have already been trained to take care of their children's breathing, and the questionnaires will be completed at the beginning and two weeks after the end of the intervention.  The educational content will be provided to the control group after the completion of the research.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Children's sleep quality in Owens et al.'s questionnaire. Timepoint: At the beginning of the study (before the start of the intervention) and 14 days after the start of the intervention. Method of measurement: Owens et al.'s Children's Sleep Habits Questionnaire.</prim_outcome>
      <prim_outcome>Parental stress. Timepoint: At the beginning of the study (before the start of the intervention) and 14 days after the start of the intervention. Method of measurement: stress response inventory 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>Bagheiat-allah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-03-01</approval_date>
        <contact_name>Ethics committee in biomedical research</contact_name>
        <contact_address>Research Management,Ground Floor, Research Institute of Baqiyatullah University of Medical Sciences, tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
