<?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>IRCT20180103038211N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-06-05</date_registration>
      <primary_sponsor>Arak University of Medical Sciences</primary_sponsor>
      <public_title>The effect of diaphragmatic pursed lip breathing on the anxiety of hysterectomy</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of diaphragmatic and pursed lip breathing on the anxiety of patients undergoing hysterectomy surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>126</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/28822</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, block randomization was used. Random numbers table was used to determine the blocks, Blinding description: Individuals in one group are unaware of the type of intervention in other groups. Also, the person who collects data for each group is unaware of the intervention of other groups. The data analyzer will be unaware of the type of intervention assigned to each group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>ANEXITY.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: First, diaphragmatic breathing (DB) is taught to patients using simple and intelligible sentences through individualized face to face training .In order to ensure that the type of respiration is taught in the correct way in each group, trained patients will perform the trained breathing in the presence of the researcher in two 20-minute sessions with a two hour interval just a day before the surgery.Diaphragmatic breathing technique is as follows: Patient lies in a comfortable position on the back. Then, puts one hand on the chest and the other hand on the abdomen. In this position, patient exhales somehow, the hand on the abdomen to be pulled forward while pushing in and brings out the air from lungs slowly. During the expiration, holds the hand on the chest in the same condition. Intervention 2: Intervention group 2: First,  pursed lip breathing (PLB)  is taught to patients using simple and intelligible sentences through individual face to face training .In order to ensure that the type of respiration is taught in the correct way in each group, trained patients will perform the trained breathing in the presence of the researcher in two 20-minute sessions with a two hour interval just a day before the surgery. Breathing technique: The patient sits in a comfortable position and closes his/her mouth and breathes a deep breath through the nose and with the lips of the bud (whistling mode) exhales air through the mouth. The patient should breathe so that expiration time (exhale through the mouth) will be twice of the inspiration time (inhale air through the nose). That means inspiration time will be 2 seconds and expiration time will be 4 seconds. Intervention 3: Control group:  Individuals in the control group do not receive any intervention. Only the researcher will be present at the bedside for 20 minutes without giving the education to the patient and will fill in the demographic questionnaire and the Spielberger anxiety test. This action will be done to remove the effect of the researcher's presence.</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 No more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fahimeh Davodabady</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Arak University of Medical Sciences, Basij Square, Sardasht</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6941-7-38481</zip>
        <telephone>+98 86 3417 3503</telephone>
        <email>fahimedavodabady@gmail.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fahimeh Davodabady</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Arak University of Medical Sciences, Basij Square, Sardasht</address>
        <city>Arak</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6941-7-38481</zip>
        <telephone>+98 86 3417 3503</telephone>
        <email>fahimedavodabady@gmail.com</email>
        <affiliation>Arak University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The presence of benign and malignant gynecological problems
Being alert after surgery
being hospitalized at least one day before and two days after the surgery
Patient Satisfaction to Participate in Research</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>59 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Having another surgery in addition to ovariectomy
Having a history of using breathtaking techniques to control anxiety
Haveing a history of taking sedative, analgesic or antianxiety drugs for more than a month
Incidence of surgical complications such as severe bleeding, acute infection and hospitalization in intensive care unit
Having diseases like psychological disorders, sensory and motor disorders, visual impairment and hearing loss
Having drug addiction</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: First, diaphragmatic breathing (DB) is taught to patients using simple and intelligible sentences through individualized face to face training .In order to ensure that the type of respiration is taught in the correct way in each group, trained patients will perform the trained breathing in the presence of the researcher in two 20-minute sessions with a two hour interval just a day before the surgery.Diaphragmatic breathing technique is as follows: Patient lies in a comfortable position on the back. Then, puts one hand on the chest and the other hand on the abdomen. In this position, patient exhales somehow, the hand on the abdomen to be pulled forward while pushing in and brings out the air from lungs slowly. During the expiration, holds the hand on the chest in the same condition.</i_keyword>
      <i_keyword>Intervention group 2: First,  pursed lip breathing (PLB)  is taught to patients using simple and intelligible sentences through individual face to face training .In order to ensure that the type of respiration is taught in the correct way in each group, trained patients will perform the trained breathing in the presence of the researcher in two 20-minute sessions with a two hour interval just a day before the surgery. Breathing technique: The patient sits in a comfortable position and closes his/her mouth and breathes a deep breath through the nose and with the lips of the bud (whistling mode) exhales air through the mouth. The patient should breathe so that expiration time (exhale through the mouth) will be twice of the inspiration time (inhale air through the nose). That means inspiration time will be 2 seconds and expiration time will be 4 seconds.</i_keyword>
      <i_keyword>Control group:  Individuals in the control group do not receive any intervention. Only the researcher will be present at the bedside for 20 minutes without giving the education to the patient and will fill in the demographic questionnaire and the Spielberger anxiety test. This action will be done to remove the effect of the researcher's presence.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Level of anxiety. Timepoint: Measurement of the anxiety level at the night before surgery, half an hour before the surgery, and after full vigilance after surgery. Method of measurement: Spielberg-er Questionnaire, State-Trait Anxiety Inventory (STAI).</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>Arak University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-11-22</approval_date>
        <contact_name>Ethics committee of Arak University of Medical Sciences</contact_name>
        <contact_address>Arak University of Medical Sciences, Basij Square, Sardasht Arak Markazi Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
