<?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>IRCT20240130060853N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-02-29</date_registration>
      <primary_sponsor>University of Kerbala</primary_sponsor>
      <public_title>Comparing the Effect of Using Super Supraglottic Swallow Maneuver and Hyoid Lift Maneuver  in Stroke Patients with Dysphagia</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the Effect of Using Super Supraglottic Swallow Maneuver and Hyoid Lift Maneuver on Dysphagia in Patients with Stroke</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-10-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>75</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/75702</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Dysphagia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: After assessing the level of dysphagia, the sample will be allocated into three groups: One of the intervention groups perform the super supra glottic swallow maneuver This maneuver involves a person holding a tight breath, swallowing while keeping the airway tightly closed, then immediately coughing after the swallow. Instructed the patients to perform this exercise 3 times daily for consecutive 7 days. Two intervention group: hyoid lift maneuver. This exercise will help build swallowing muscle strength and control. Place a few small pieces of paper (about one inch in diameter) over a blanket or a towel. Then place a straw in mouth and suck one of the pieces of paper to its tip. Keep sucking on the straw to keep the paper attached, bring it over a cup or a similar container and stop sucking. This will release the paper into the container. Goal for each session is to place about five to 10 pieces of paper into the container. Intervention 2: Control group: The control group received no interventions; instead, they received pre-test and post-test assessments after 7 days, as did the other groups, and they will be compared to the other groups in the study. Then patients in all groups were evaluated prior to the intervention after 7 days by using the GUSS.</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 data will be the results of the GUSS that measure.
patients' dysphagia levels in both the control and intervention
groups.

When:
God Willing, once the article is published, the data will be
available after 6 months of publication. If the article will
be published in a subscribed journal, the data will be
available after one year because of the policy of the
subscribed journals.

To whom:
With academic nurses and any researcher who is
interested in the data.

Conditions:
The data could be used after getting permission via
email. Also, users need to acknowledge the owner

Where to obtain:
Users can ask for the data and permission via email.
Hawraa alhesnawi is the corresponding author. He will
contact whoever he requests the information from. His
email is hawraa.abdalzahraa@s.uokerbala.edu.iq
works at Imam al hussain medical city.
The address is hai-alusraa district, Karbala, Iraq.

How to obtain:
Users can ask for the data and permission via email.
Hawraa alhesnawi is the corresponding author. He will
contact whoever he requests the information from. His
email is hawraa.abdalzahraa@s.uokerbala.edu.iq

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hawraa Abd Alzahraa Alhesnawi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hai-Alhur</address>
        <city>Kerbala</city>
        <country1>Iraq</country1>
        <zip>56001</zip>
        <telephone>+964 781 478 0017</telephone>
        <email>hawraa.abdalzahraa@s.uokerbala.edu.iq</email>
        <affiliation>University of Kerbala</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hawraa Abd Alzahraa Alhesnawi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hai-Alhur</address>
        <city>Kerbala</city>
        <country1>Iraq</country1>
        <zip>56001</zip>
        <telephone>+964 781 478 0017</telephone>
        <email>hawraa.abdalzahraa@s.uokerbala.edu.iq</email>
        <affiliation>University of Kerbala</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iraq</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients who diagnosed with Acute Stroke and from 1 days to 6 months with symptoms of Dysphagia.
Voluntary agreement to participation in this study
Patients who are conscious, alert, cooperative, obeys commands with the ability to imitate the nurse
Both male and female gender</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pilot study participants
Patients with stroke who do not have a dysphagia.
Patients with other neurological disorders
Patient who has a history of dysphagia unrelated to the current stroke
Patients who diagnosed with pneumonia were excluded from the study.
Patients who declined to enroll in the study.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R13.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Dysphagia</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: After assessing the level of dysphagia, the sample will be allocated into three groups: One of the intervention groups perform the super supra glottic swallow maneuver This maneuver involves a person holding a tight breath, swallowing while keeping the airway tightly closed, then immediately coughing after the swallow. Instructed the patients to perform this exercise 3 times daily for consecutive 7 days. Two intervention group: hyoid lift maneuver. This exercise will help build swallowing muscle strength and control. Place a few small pieces of paper (about one inch in diameter) over a blanket or a towel. Then place a straw in mouth and suck one of the pieces of paper to its tip. Keep sucking on the straw to keep the paper attached, bring it over a cup or a similar container and stop sucking. This will release the paper into the container. Goal for each session is to place about five to 10 pieces of paper into the container.</i_keyword>
      <i_keyword>Control group: The control group received no interventions; instead, they received pre-test and post-test assessments after 7 days, as did the other groups, and they will be compared to the other groups in the study. Then patients in all groups were evaluated prior to the intervention after 7 days by using the GUSS.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The primary outcome variable is the level of Dysphagia that can be changed based on super supraglottic swallow maneuver and hyoid lift maneuver. Timepoint: Before intervention and  7 days after intervention. Method of measurement: The GUSS Scale that used to assess the the level of dysphagia.</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>The author of the trial is the funding source</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-11-15</approval_date>
        <contact_name>Ethics committee in College of Nursing at University of Kerbala</contact_name>
        <contact_address>Hai-Almuadafeen Kerbala Hai-Alhur Iraq</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
