<?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>IRCT20191117045462N11</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-01-22</date_registration>
      <primary_sponsor>Riphah international university</primary_sponsor>
      <public_title>COMPARATIVE EFFECTS OF DIAPHRAGMATIC BREATHING AND  PACED BREATHING ON PULMONARY FUNCTION, HOT FLASHES AND POST-MENOPAUSAL SYNDROME IN WOMEN</public_title>
      <acronym></acronym>
      <scientific_title>COMPARATIVE EFFECTS OF DIAPHRAGMATIC BREATHING AND  PACED BREATHING ON PULMONARY FUNCTION, HOT FLASHES AND POST-MENOPAUSAL SYNDROME IN WOMEN</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-12-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>44</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/73947</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Taking into account the above mentioned inclusion and exclusion criteria, patients will be recruited in the study through convenient sampling technique and then will be randomly assigned to each group through Random Sampling by lottery method. Labeled as  group A and  group B.</study_design>
      <phase>N/A</phase>
      <hc_freetext>post-menopausal syndrome patients.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group A:    Diaphragmatic Breathing group : Group A will be treated with diaphragmatic breathing cycles (6breaths/min), including 5s of inhalation and 5s exhalation, for  twice a  day and  15 minutes per day for 3 weeks . Intervention 2: Intervention group B:   Paced Breathing Group :Group B will be treated by Paced Breathing slowly count for four while inhaling through the nose and feel the abdomen rise, hold breath for 1sec and slowly exhaling through lips repeat exercise 6 to 8 minutes per minutes twice a day for 3 weeks. Intervention 3: Baseline intervention:  Lifestyle intervention adviceEach patient in both groups will instructed to follow lifestyle intervention advice. The advice included avoiding eating or drinking before going to bed , and increasing consumption of a whole diet rich in fruit, vegetables, carbohydrates, and legumes . Moreover, advice included preparing for sleep by mentally calming down at night and avoiding afternoon naps, making sure the bedroom was comfortable, warm, calm, and dark , avoiding sleeping near a light source , going to bed when feeling tired, getting up when unable to sleep, and rising at the same time every morning.</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 N/A</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Gullnaz Yousaf</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>13-14-C-civic center, township near Hamdard Chowk, Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 42 35126110</telephone>
        <email>wajeeha_z@yahoo.com</email>
        <affiliation>Riphah international university</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>wajeeha</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>13-14-C-civic center, township near Hamdard Chowk, Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 42 35126110</telephone>
        <email>wajeeha_z@yahoo.com</email>
        <affiliation>Riphah international university</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Menopausal women having symptoms
Hot Flashes during menopause
Not currently taking hormonal replacement therapy, a psychoactive medication, and not using complementary therapy for menopausal symptoms</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Had hormonal replacement therapy
Having any cardiac and lung diseases will be excluded
If they had history of breast cancer , mayocardial infarction and pulmonary embolism</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>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group A:    Diaphragmatic Breathing group : Group A will be treated with diaphragmatic breathing cycles (6breaths/min), including 5s of inhalation and 5s exhalation, for  twice a  day and  15 minutes per day for 3 weeks .</i_keyword>
      <i_keyword>Intervention group B:   Paced Breathing Group :Group B will be treated by Paced Breathing slowly count for four while inhaling through the nose and feel the abdomen rise, hold breath for 1sec and slowly exhaling through lips repeat exercise 6 to 8 minutes per minutes twice a day for 3 weeks.</i_keyword>
      <i_keyword>Baseline intervention:  Lifestyle intervention adviceEach patient in both groups will instructed to follow lifestyle intervention advice. The advice included avoiding eating or drinking before going to bed , and increasing consumption of a whole diet rich in fruit, vegetables, carbohydrates, and legumes . Moreover, advice included preparing for sleep by mentally calming down at night and avoiding afternoon naps, making sure the bedroom was comfortable, warm, calm, and dark , avoiding sleeping near a light source , going to bed when feeling tired, getting up when unable to sleep, and rising at the same time every morning.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Post-menopausal symptoms. Timepoint: pre-post treatment. Method of measurement: Menopausal rating scale,Hot flash-related daily interference scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Hot flashes. Timepoint: pre-post treatment. Method of measurement: Hot flash-related daily interference scale.</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>Riphah international university</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-11-26</approval_date>
        <contact_name>Riphah college of rehabilitation &amp; Allied Health Sciences</contact_name>
        <contact_address>13-14-C-civic center, township near Hamdard Chowk, Lahore Lahore punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
