To determine the effect of using super supraglottic maneuver and hyoid lift maneuver on dysphagia in patient with stroke
Design
An Quasi experimental comparative design with a minimum
sample size of 25 for each group will be used. The total
sample size would be 75 subjects, followed for 7 days from 1october 2023 to 1 Augest 2024.
Settings and conduct
This study was conducted in the medical wards in Imam Hussain Medical City and Imam Al-Hassan Al-Mujtaba Teaching Hospital in Kerbala Governorate.
Participants/Inclusion and exclusion 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.
Exclusion Criteria: Pilot study participants, Patients with stroke who do not have dysphagia, patients with other neurological disorders, patients with ET intubation, patients with tracheostomy, patient who have 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.
Intervention groups
After assessing the level of dysphagia, the sample will be allocated into three groups. One group: Super supra glottis swallow maneuver: This maneuver involves a person holding a tight breath, swallowing while keeping the airway tightly closed, then immediately coughing after the swallow. The researcher instructed the patients to perform this exercise 3 times daily for consecutive 7 days. Two group: hyoid lift maneuver: perform this maneuver 5 to 10 minutes for 7 days. Three groups: control groups and they no received any interventions to participant; instead, they received pre-test and post-test assessments after seven days.
Main outcome variables
Reducing dysphagia severity level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240130060853N1
Registration date:2024-02-29, 1402/12/10
Registration timing:registered_while_recruiting
Last update:2024-02-29, 1402/12/10
Update count:0
Registration date
2024-02-29, 1402/12/10
Registrant information
Name
Hawraa Al-Hesnawy
Name of organization / entity
University of Kerbala
Country
Iraq
Phone
+964 781 478 0017
Email address
hawraa.abdalzahraa@s.uokerbala.edu.iq
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-01, 1402/07/09
Expected recruitment end date
2024-03-10, 1402/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Effect of Using Super Supraglottic Swallow Maneuver and Hyoid Lift Maneuver on Dysphagia in Patients with Stroke
Public title
Comparing the Effect of Using Super Supraglottic Swallow Maneuver and Hyoid Lift Maneuver in Stroke Patients with Dysphagia
Purpose
Education/Guidance
Inclusion/Exclusion 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
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.
Age
From 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee in College of Nursing at University of Kerbala
Street address
Hai-Almuadafeen
City
Kerbala
Postal code
56001
Approval date
2023-11-15, 1402/08/24
Ethics committee reference number
4626
Health conditions studied
1
Description of health condition studied
Dysphagia
ICD-10 code
R13.1
ICD-10 code description
Dysphagia
Primary outcomes
1
Description
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.
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Other
2
Description
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.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hussain Medical City
Full name of responsible person
Hawraa Abd Alzahraa Alhesnawi
Street address
Hai-Alusraa Street
City
Kerbala
Postal code
56001
Phone
+964 781 478 0017
Email
hawraa.abdalzahraa@s.uokerbala.edu.iq
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Kerbala
Full name of responsible person
Hawraa Abd Alzahraa Alhesnawi
Street address
Hai-Almudafeen Street
City
Kerbala
Postal code
56001
Phone
+964 781 478 0017
Email
hawraa.abdalzahraa@s.uokerbala.edu.iq
Web page address
https://nursing.uokerbala.edu.iq/wp/en/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
The author of the trial is the funding source
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
University of Kerbala
Full name of responsible person
Hawraa Abd Alzahraa Alhesnawi
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursing
Street address
Hai-Alhur
City
Kerbala
Province
Kerbala
Postal code
56001
Phone
+964 781 478 0017
Email
hawraa.abdalzahraa@s.uokerbala.edu.iq
Web page address
https://nursing.uokerbala.edu.iq/wp/en/
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Kerbala
Full name of responsible person
Hawraa Abd Alzahraa Alhesnawi
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursing
Street address
Hai-Alhur
City
Kerbala
Province
Kerbala
Postal code
56001
Phone
+964 781 478 0017
Email
hawraa.abdalzahraa@s.uokerbala.edu.iq
Person responsible for updating data
Contact
Name of organization / entity
University of Kerbala
Full name of responsible person
Hawraa Abd Alzahraa Alhesnawi
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursing
Street address
Hai-Alhur
City
Kerbala
Province
Kerbala
Postal code
56001
Phone
+964 781 478 0017
Email
hawraa.abdalzahraa@s.uokerbala.edu.iq
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The data will be the results of the GUSS that measure.
patients' dysphagia levels in both the control and intervention
groups.
When the data will become available and for how long
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 data/document is available
With academic nurses and any researcher who is
interested in the data.
Under which criteria data/document could be used
The data could be used after getting permission via
email. Also, users need to acknowledge the owner
From where data/document is obtainable
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.
What processes are involved for a request to access data/document
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