<?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>IRCT20240216061027N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-03-28</date_registration>
      <primary_sponsor>Yazd University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of regular breathing on anxiety</public_title>
      <acronym></acronym>
      <scientific_title>عنوان طرح(انگلیسی)	Investigating the effect of regular breathing on anxiety of mothers with premature infant hospitalized in the Neonatal Intensive Care Unit</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-03-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>66</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/75650</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In order to prevent the exchange of information between the intervention and control groups, a time block is used.  First, sampling is done from the control group and then the intervention, and then the questionnaires are completed by the control group, and after the number of samples in the control group is completed, sampling is stopped for 3 weeks so that the parents of the participants in the control group are discharged.  become  After that, the sampling of the intervention group will be started in the mentioned way. In each group, from the first day of sampling, the statistical consultant has provided us with a number of random numbers based on the people who are accepted from the first day, using the Random Allocation software.  Sampling is done from people who meet the entry criteria.</study_design>
      <phase>N/A</phase>
      <hc_freetext>anxiety.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The intervention group is included in the study after completing the demographic information questionnaire and checking the entry criteria if eligible, and the Spielberger anxiety questionnaire is completed before the intervention.  In this research, from the second or third day after the admission of the babies (fixation of the mother's physical condition), mothers are taught regular breathing until complete learning by the researcher.  In this type of regular breathing, hey-hu technique is used.  In this method, mothers first take a deep breath and while exhaling, they whisper hei, and they take a deep breath again and exhale by whispering ho. This work is practiced and repeated for a precise performance.  The breathing rate is 16-20 times per minute for mothers.  Breathing exercises by mothers every day at two specific times, once in the morning after the doctor's visit and once in the evening, each time for 20 minutes and every five minutes and each time for one minute (one minute of regular breathing and four minutes of rest) for  It is done for seven days according to the method taught.  After the intervention, the Spielberger anxiety level questionnaire is completed again by the mothers. Intervention 2: Control group: After completing the demographic information questionnaire and checking the entry criteria, the control group entered the study and completed the Spielberger anxiety questionnaire.  The control group received usual ward care.  After the end of the study, the Spielberger anxiety questionnaire is completed again by the mothers.</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:
The main results of this study are sharing and it is not possible to identify people due to the confidentiality of their personal information before sharing

When:
Time period of 3 months after printing the results

To whom:
Researchers working in academic and scientific institutions

Conditions:
Do not make unauthorized and personal use of the data
 They are only allowed to publish scientific results

Where to obtain:
To the email address Ali25ghobad@gmail.com
 Contact number 09338903314
 or refer to Mrs. Doktorpour Mohed's office at the address of the Faculty of Nursing in Yazd.

How to obtain:
Request by email
 or in person
 Duration of one week

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Alireza Ghobad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Faqihi Hospital, Zand Boulevard, Shiraz</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7134846114</zip>
        <telephone>+98 71 3232 5552</telephone>
        <email>Ali25ghobad@gmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Alireza Ghobad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Faqihi Hospital, Zand Boulevard, Shiraz</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۷۱۳۴۸۴۶۱۱۴</zip>
        <telephone>+98 71 3232 5552</telephone>
        <email>Ali25ghobad@gmail.com</email>
        <affiliation>Yazd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1) Gestational age 26 to 36 weeks
2) They do not have the experience of admitting a newborn or premature baby in the neonatal intensive care unit, regardless of the birth order of the baby
3) Don't have any significant crises in the last six months (loss of parents, divorce)
4) Babies should be hospitalized in the intensive care unit for at least three days
5) People who want to participate in the study
6) Parents should not participate in any other intervention program on anxiety during the study</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>The baby has a recognizable abnormality that increases the mother's anxiety
Taking anti-anxiety and anti-depressant drugs
Working mothers in healthcare and medical science environments</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F41</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other anxiety disorders</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The intervention group is included in the study after completing the demographic information questionnaire and checking the entry criteria if eligible, and the Spielberger anxiety questionnaire is completed before the intervention.  In this research, from the second or third day after the admission of the babies (fixation of the mother's physical condition), mothers are taught regular breathing until complete learning by the researcher.  In this type of regular breathing, hey-hu technique is used.  In this method, mothers first take a deep breath and while exhaling, they whisper hei, and they take a deep breath again and exhale by whispering ho. This work is practiced and repeated for a precise performance.  The breathing rate is 16-20 times per minute for mothers.  Breathing exercises by mothers every day at two specific times, once in the morning after the doctor's visit and once in the evening, each time for 20 minutes and every five minutes and each time for one minute (one minute of regular breathing and four minutes of rest) for  It is done for seven days according to the method taught.  After the intervention, the Spielberger anxiety level questionnaire is completed again by the mothers.</i_keyword>
      <i_keyword>Control group: After completing the demographic information questionnaire and checking the entry criteria, the control group entered the study and completed the Spielberger anxiety questionnaire.  The control group received usual ward care.  After the end of the study, the Spielberger anxiety questionnaire is completed again by the mothers.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The anxiety score in the Spielberger questionnaire ranges from none or the least to the most severe. Timepoint: Spielberger anxiety questionnaire before the start of the intervention and after the end of the intervention (seven days). Method of measurement: Spielberger anxiety questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Anxiety score of mothers with hospitalized premature infant. Timepoint: before the start of the intervention and after the start of the intervention (seven days). Method of measurement: Spielberger questionnaire with 40 questions.</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>Yazd University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-01-03</approval_date>
        <contact_name>Ethics Committee of Yazd University of Medical Sciences</contact_name>
        <contact_address>Shahid Sadoughi Blvd., Ba Honar Square, Yazd Yazd Yazd Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
