<?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>IRCT20220626055280N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-01-21</date_registration>
      <primary_sponsor>Rashid Latif Medical College</primary_sponsor>
      <public_title>Effect of diaphragmatic breathing exercise and progressive relaxation technique in patient having preeclampsia.</public_title>
      <acronym></acronym>
      <scientific_title>Effect of diaphragmatic breathing exercise and progressive relaxation technique in patient having preeclampsia.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-01-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>26</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67925</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients were allocated into two groups i.e.; Group A and Group B, by lottery method. Lottery method is a type of simple random sampling. In this method, each participant of the trial is assigned a unique number. In the next step these numbers are written on separate cards which are physically similar in shape, size, color etc. 30 cards were used. Then they are placed in a basket and thoroughly mixed. In the last step the slips are taken out randomly without looking at them and are placed into two sets randomly. Total of 26 cards were taken out, 13 participants in each group, Blinding description: The blinding is achieved by concealment in which the treatment allocation for each patient is not revealed to the patient. This is done to avoid biasness.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Pre-eclampsia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group will receive Diaphragmatic breathing exercise , progressive relaxation technique and routine hypertensive medication.                                                                                           Progressive muscular relaxation technique will be performed by Conscious removal of tension from the muscles: Contractions start from the hands to the sole muscles (each muscle group was contracted for 5–7 sand then relaxed for 30–40 s). Then make Fist and tighten your hand, then relax. Now Push the elbow down on the chair and then relax arm. Raise your eyebrows and wrinkle your forehead, then relax your forehead. Furthermore, Close your eyes tightly, then open slowly. For Muscles of the central part of the face, Cross your eyes and pull the nose upwards. Moreover, to relax the lower part of face, jaw and neck, Tie your teeth and tighten the corners of your mouth, then relax. For Shoulders, Raise your shoulders as if you want to touch the ears, then relax. Chest and abdomen muscles can be relaxed by taking a deep breath and hold it, then exhale (Abdominal muscle contraction was avoided due to avoiding preterm labor contractions in this study). For Legs muscles, Pull your toes down, away from your body, and then relax. Furthermore, for anterior thighs, Contract the muscles above and below the thigh and then relax. For Hamstrings muscle Push heels down into floor ,tighten hamstrings muscles and relax. Lastly For Calves, Points toes toward head and relax. Curl toes toward the bottom of feet and relax. At the Completion, Check the whole body for the remaining tension, If you experience tension or pressure in certain muscles, repeat the muscle contraction and relaxation for that group of muscles.                                                            Diaphragmatic Breathing will be done by Getting comfortable. You can lie on your back in bed or plinth with a pillow under your head and knees. Or you can sit in a chair with your shoulders, head, and neck supported against the back of the chair and Breathe in through your nose. Let your belly fill with air. Then Breathe out through your nose. Now, Place one hand on your belly and the other hand on your chest. As you breathe in, feel your belly rise. As you breathe out, feel your belly lower. The hand on your belly should move more than the one that's on your chest. Take three more full, deep breaths. Breathe fully into your belly as it rises and falls with your breath. The technique will be applied for 3 days a week, and a single session will be 20 minutes. 5 minutes for diaphragmatic breathing exercise and 15 minutes for progressive relaxation technique. Intervention 2: Control group: The control group only receive routine hypertensive medication.</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>Kalsoom</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>35-Km Ferozepur road Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54600</zip>
        <telephone>+92 318 8384198</telephone>
        <email>kalsoomkanwal51@gmail.com</email>
        <affiliation>Rashid Latif Medical College</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nazeer Ahmad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>35-Km Ferozepur road Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54600</zip>
        <telephone>+92 333 8054247</telephone>
        <email>nazeer.ahmad@rlmc.edu.pk</email>
        <affiliation>Rashid Latif Medical College</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Systolic BP ≥135 mmHg or diastolic BP ≥85 mmHg
Preeclampsia female diagnosed by physician</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Chronic hypertension
Contraction or leakage of fluid during study
Bleeding ,heart disease and renal diseases</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>O14.00</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Mild to moderate pre-eclampsia, unspecified trimester</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group will receive Diaphragmatic breathing exercise , progressive relaxation technique and routine hypertensive medication.                                                                                           Progressive muscular relaxation technique will be performed by Conscious removal of tension from the muscles: Contractions start from the hands to the sole muscles (each muscle group was contracted for 5–7 sand then relaxed for 30–40 s). Then make Fist and tighten your hand, then relax. Now Push the elbow down on the chair and then relax arm. Raise your eyebrows and wrinkle your forehead, then relax your forehead. Furthermore, Close your eyes tightly, then open slowly. For Muscles of the central part of the face, Cross your eyes and pull the nose upwards. Moreover, to relax the lower part of face, jaw and neck, Tie your teeth and tighten the corners of your mouth, then relax. For Shoulders, Raise your shoulders as if you want to touch the ears, then relax. Chest and abdomen muscles can be relaxed by taking a deep breath and hold it, then exhale (Abdominal muscle contraction was avoided due to avoiding preterm labor contractions in this study). For Legs muscles, Pull your toes down, away from your body, and then relax. Furthermore, for anterior thighs, Contract the muscles above and below the thigh and then relax. For Hamstrings muscle Push heels down into floor ,tighten hamstrings muscles and relax. Lastly For Calves, Points toes toward head and relax. Curl toes toward the bottom of feet and relax. At the Completion, Check the whole body for the remaining tension, If you experience tension or pressure in certain muscles, repeat the muscle contraction and relaxation for that group of muscles.                                                            Diaphragmatic Breathing will be done by Getting comfortable. You can lie on your back in bed or plinth with a pillow under your head and knees. Or you can sit in a chair with your shoulders, head, and neck supported against the back of the chair and Breathe in through your nose. Let your belly fill with air. Then Breathe out through your nose. Now, Place one hand on your belly and the other hand on your chest. As you breathe in, feel your belly rise. As you breathe out, feel your belly lower. The hand on your belly should move more than the one that's on your chest. Take three more full, deep breaths. Breathe fully into your belly as it rises and falls with your breath. The technique will be applied for 3 days a week, and a single session will be 20 minutes. 5 minutes for diaphragmatic breathing exercise and 15 minutes for progressive relaxation technique</i_keyword>
      <i_keyword>Control group: The control group only receive routine hypertensive medication</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Blood Pressure. Timepoint: Pre and Post 1 Month. Method of measurement: Manual sphygmomanometer was used to evaluate blood pressure.</prim_outcome>
      <prim_outcome>Oxygen Saturation. Timepoint: Pre and Post 1 Month. Method of measurement: Pulse oximeter is used to measure oxygen saturation.</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>Rashid Latif Medical College</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-10-05</approval_date>
        <contact_name>Institutional Review Board of Rashid Latif Medical College</contact_name>
        <contact_address>35-Km Ferozepur road Lahore Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
