<?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>IRCT20210722051954N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-11-09</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of foot reflexology massage on sleep quality of school-age children with chronic lung diseases</public_title>
      <acronym>ماساژ بازتابی کف پا</acronym>
      <scientific_title>The effect of foot reflexology massage on sleep quality of school-age children with chronic lung diseases admitted to selected hospitals affiliated to Tehran University of Medical Sciences in 1400</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-09-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/57776</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Random sampling is one of the statistical sampling methods in which people in the community have an equal chance of being selected. In this method, the required people or objects are randomly selected from the list of statistical population that has been numbered and prepared for this purpose. According to the law of probability, selected individuals must have the same characteristics as the community from which they were selected.
Children were assigned to the intervention and control groups using a random division method (for example, the last number of even files of the intervention group and the last number of individual files of the control group). For example, the file number is mentioned as 04-34-86, considering that the number 6 is even, then in the present study, it will be included in the intervention group, and vice versa, Blinding description: The children in the control group and their families are unaware of the assignment of the study groups. Principles will be done for the intervention group according to the principles that the researcher has passed the relevant course.
How to do the work varies according to the pressure on the sole of the foot and is not recognizable to the children family.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: asthma. Condition 2: cystic fibrosis.</hc_freetext>
      <i_freetext>Intervention 1: In this study, foot reflexology massage was performed by performing a non-invasive complementary medicine procedure in 3 sessions of 30 minutes. Every day, the evening of massage for school-age children diagnosed with chronic lung diseases is hospitalized in hospitals affiliated to Tehran universities. Each leg is massaged 5 times in each session. Intervention 2: Control group: foot massage without pressure on specific points.</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 includes the age of the participants and the type of disease and how it is performed and the reportable result.

When:
2021/11/19

To whom:
Nursing students and other related fields

Conditions:
Related research

Where to obtain:
send email to researcher  or professor

How to obtain:
Submit the desired title of the researcher and state the field of study

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Elnaz Moghani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No11.Ladadan 6 Ave. Vakil Abad Blvd</address>
        <city>MASHHAD</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9179653968</zip>
        <telephone>+98 51 3865 1750</telephone>
        <email>El.moghani@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Elnaz Moghani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No11.Ladan 6 Ave. Vakil Abad Blvd</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9179653968</zip>
        <telephone>+98 51 3865 1750</telephone>
        <email>El.moghani@gmail.com</email>
        <affiliation>Tehran 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>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The children did not have foot ulcers
The children were between the ages of 6-12.
The studied child had no history of foot surgery
Days and nights were intended for the child's parents</inclusion_criteria>
      <agemin>6 years</agemin>
      <agemax>12 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Occurrence of any situation for the patient and his active family member that necessitates interventional measures or has a clear effect on quality of life, such as physical, psychological, family and economic crisis
The presence of the patient and his active family member in another educational program related to the quality of the child's sleep (except for the routine program of the center)
Any underlying disease (other than the diseases considered in this study) that restricts the patient's breathing, such as injury, burn and chest dressing, chest fracture, and...
Any conditions that exclude the possibility of intervention (foot massage), including foot fractures, wounds and foot dressings and...
Children did not have other chronic diseases that prevent reflexology massage</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J45</hc_code>
      <hc_code>E84</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Asthma</hc_keyword>
      <hc_keyword>Cystic fibrosis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In this study, foot reflexology massage was performed by performing a non-invasive complementary medicine procedure in 3 sessions of 30 minutes. Every day, the evening of massage for school-age children diagnosed with chronic lung diseases is hospitalized in hospitals affiliated to Tehran universities. Each leg is massaged 5 times in each session.</i_keyword>
      <i_keyword>Control group: foot massage without pressure on specific points</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sleep quality score in the sleep quality questionnaire. Timepoint: Before the intervention and Immediately after the intervention. Method of measurement: Sleep quality questionnaire called CHSQ.</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-07-29</approval_date>
        <contact_name>Ethics Committee of Islamic Azad University of Medical Sciences, Tehran</contact_name>
        <contact_address>No11.ladan6 ave .vakil abad blvd. Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
