<?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>IRCT20220803055611N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-08-16</date_registration>
      <primary_sponsor>Yasouj University of Medical Sciences</primary_sponsor>
      <public_title>The effect of Core Stability Exercises on sleep habits and quality of life in children with nocturnal enuresis</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Core Stability Exercises on sleep habits and quality of life in children with nocturnal enuresis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65177</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Supportive, Randomization description: Block random allocation in such a way that first by multiplying the number of studied groups (two groups) by 2, the number of samples in each block is equal to 4, through factorial calculation, the number of samples in each block (24=1×2×3×4= 4), the number of blocks resulting from all modes of arrangement of people will be calculated as 24 blocks. Then, since the number of people in each block will be 4 people and the estimated sample size is 60 people, therefore, by matching 20 random numbers generated by the Sample Randomizer software with the numbers of the aforementioned states, how to arrange 60 people in the research sample and assign each number from 1 Up to 60 will be assigned to one of the specified intervention and control groups and a block random allocation list will be compiled. After fully explaining and explaining the objectives of the study, eligible research samples will be selected and based on the time priority of referrals, a code will be assigned to each of them, and by matching that number with the random block allocation list, the patients participating in the research will be assigned to one of the intervention and control groups. This process will continue until the estimated sample size is completed.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Children with nocturnal enuresis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In eight weeks, the exercises will be done three sessions a week (the interval between the training sessions is one day) and each session will be 45 minutes as a group. The exercises will be as follows: The first session: 1- Raising the arms and legs in a round position 2- Bridging in such a way that the hips and waist rise from the ground. The number of performances of each two hands is 10. The second session: 1- Raising the arms and legs in a distant position 2- Bridging so that the hips and waist rise from the ground. The number of performances of each two hands is 15. The third session: - Raising the arms and legs in a round position 2- Bridging in such a way that the hips and waist rise from the ground. The number of performances of each two hands is 20. The fourth session: - Raising the arms and legs in a round position 2- Bridging in such a way that the hips and waist rise from the ground. The number of performances of each two hands is 25. Fifth session: 1- Lying down with rotation 2- Half lying down. The number of performances of each two hands is 10. Sixth session: 1- Lying down with rotation 2- Half lying down. The number of performances of each two hands is 15. Seventh session: 1- Semi-recumbent sitting 2- Recumbent sitting with rotation. The number of performances of each two hands is 20. Eighth session: 1- Semi-recumbent sitting 2- Recumbent sitting with rotation. The number of performances of each two hands is 25. Intervention 2: Control group: non-intervention: this training group will not be given.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nastaran Kheirandish</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 1, Aria Building, 49 North Motahari Alley, Shiraz, Fars, Islamic Republic of Iran</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7186897477</zip>
        <telephone>+98 74 3323 5138</telephone>
        <email>nkheyrandish1373@gmail.com</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nastaran Kheirandish</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 1, Aria Building, 49 North Motahari Alley, Shiraz, Fars, Islamic Republic of Iran</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7186897477</zip>
        <telephone>+98 74 3323 5138</telephone>
        <email>nkheyrandish1373@gmail.com</email>
        <affiliation>Yasouj University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age range from 6 to 12 years
Diagnosis of primary and secondary nocturnal enuresis by a specialist in children's kidney diseases
Not doing sports professionally
The quality of life of children with a cut-off point of less than 25 (low quality of life) based on the questionnaire of the quality of life of children
Having the physical ability to participate in sports exercises according to the doctor's opinion
Not suffering from concomitant diseases (cardiac, pulmonary and diabetes)
Consent to participate in the study and sign the informed consent form by the parents and the child</inclusion_criteria>
      <agemin>6 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Previous patient participation in studies similar to the current study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F98.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Nonorganic enuresis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In eight weeks, the exercises will be done three sessions a week (the interval between the training sessions is one day) and each session will be 45 minutes as a group. The exercises will be as follows: The first session: 1- Raising the arms and legs in a round position 2- Bridging in such a way that the hips and waist rise from the ground. The number of performances of each two hands is 10. The second session: 1- Raising the arms and legs in a distant position 2- Bridging so that the hips and waist rise from the ground. The number of performances of each two hands is 15. The third session: - Raising the arms and legs in a round position 2- Bridging in such a way that the hips and waist rise from the ground. The number of performances of each two hands is 20. The fourth session: - Raising the arms and legs in a round position 2- Bridging in such a way that the hips and waist rise from the ground. The number of performances of each two hands is 25. Fifth session: 1- Lying down with rotation 2- Half lying down. The number of performances of each two hands is 10. Sixth session: 1- Lying down with rotation 2- Half lying down. The number of performances of each two hands is 15. Seventh session: 1- Semi-recumbent sitting 2- Recumbent sitting with rotation. The number of performances of each two hands is 20. Eighth session: 1- Semi-recumbent sitting 2- Recumbent sitting with rotation. The number of performances of each two hands is 25.</i_keyword>
      <i_keyword>Control group: non-intervention: this training group will not be given.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Outcome number 1: Sleep habits: Sleep habits means the score that a person gets from answering the questions of the children's sleep habits questionnaire. Timepoint: The amount of sleeping habits of the patients at the beginning of the study (before the start of the intervention) and 48 hours after the completion of the interventions. Method of measurement: Children's Sleep Habits Questionnaire.</prim_outcome>
      <prim_outcome>Outcome number 2: Quality of life: Quality of life means the score that a person answers to the questions of the Pediatric Quality of Life Inventory. Timepoint: The level of quality of life of patients at the beginning of the study (before the start of the intervention) and 48 hours after the completion of the interventions. Method of measurement: The Pediatric Quality of Life Inventory.</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>Yasouj University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-06-14</approval_date>
        <contact_name>Ethics committee of Yasuj University of Medical Sciences</contact_name>
        <contact_address>Yasuj University of Medical Sciences, Shahid Motahari Blvd., Yasuj, Kohgiluyeh and Boyer-Ahmad, Islamic Republic of Iran Yasuj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
