To determine the level of dysphagia severity
to determine the effect of super supraglottic swallow maneuver on dysphagia in patients with stroke
Design
An Quasi-experimental study design
Settings and conduct
This study was conducted in the medical wards in Imam Hussain Medical City in Holy Kerbala City.This study also carried out at the medical wards of Imam Al-Hassan Al-Mujtaba Teaching Hospital in Kerbala Governorate
Participants/Inclusion and exclusion 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 critria:
• Pilot study participants.
• Patients with stroke who do not have adysphagia.
• patients with other neurological disorders.
• patients with ET intubation, patients with tracheostomy.
• patient who have a history of dysphagia unrelated to the current stroke
Intervention groups
super supra glottis swallow maneuver:
This manoeuvre involves a person holding a tight breath, swallowing while keeping the airway tightly closed, then immediately coughing after the swallow. It has obvious compensatory effects of keeping the airway closed longer and is often taught to help prevent aspiration.
Main outcome variables
level of dysphhagia severity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240130060853N2
Registration date:2024-05-18, 1403/02/29
Registration timing:retrospective
Last update:2024-05-18, 1403/02/29
Update count:0
Registration date
2024-05-18, 1403/02/29
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
2023-11-01, 1402/08/10
Expected recruitment end date
2024-03-21, 1403/01/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparing the effect of super supraglottic swallow maneuver on swallowing function in patients with stroke
Public title
comparing the effect of super supraglottic swallow maneuver on swallowing function in patients with stroke
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.
Exclusion criteria:
Pilot study participants.
Patients with stroke who do not have adysphagia
Patients with other neurological disorders
Patients with tracheostomy
Patient who have a history of dysphagia unrelated to the current stroke.
Age
From 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Ethical Committe in College of Nursing at University of Kerbala
Street address
hai-almudafeen
City
kerbala
Postal code
56001
Approval date
2023-11-21, 1402/08/30
Ethics committee reference number
4626
Health conditions studied
1
Description of health condition studied
dysphagia level
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
Timepoint
Before intervention ans 7 days after intervention
Method of measurement
The GUSS Scale that can be uesd to assess the level of dysphagia
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After assessing the level of dysphagia.The researcher carried out this intervention after going over the educational references and previous research, and it was established to decrease the severity of dysphagia level in patients with stroke who complain from dysphagia through application of super supra glottic swallow maneuver.The patients firstly instructed and trained about how to perform the super supra glottic swallow maneuver.That involves a person holding a tight breath, swallowing while keeping the airway tightly closed, then immediately coughing after the swallow. It has obvious compensatory effects of keeping the airway closed longer and is often taught to help prevent aspiration.
Category
Treatment - Other
2
Description
Control group: The control group received no intervention, instead they received pre-test and post-test assessment after 7 days,as did the other groups, and they will be compared to the other groups in the study.Then patients in two groups were evaluated prior to the intervention after 1week by using the GUSS.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Al-Hussain Medical City
Full name of responsible person
Kerbala Health Directorate
Street address
Hai-alusraa
City
Kerbala
Postal code
56001
Phone
+964 781 478 0017
Email
hawraa.abdalzahraa@s.uokerbala.edu.iq
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Kerbala
Full name of responsible person
Hawraa abd al-zahraa
Street address
Hai-Alhur
City
Kerbala
Postal code
56001
Phone
+964 781 478 0017
Email
hawraa.abdalzahraa@s.uokerbala.edu.iq
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
Hawraa Abd AL-zahraa
Full name of responsible person
University of Kerbala
Position
Academic Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Hai-Almudafeen
City
Karbala
Province
Kerbala
Postal code
56001
Phone
+964 781 478 0017
Email
hawraa.abdalzahraa@s.uokerbala.edu.iq
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hawraa Abd Al-zahraa
Full name of responsible person
University of KerbalA
Position
Kerbala
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Hai-Almudafeen
City
Kerbala
Province
Hai-Almudafeen
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 AL-Zahraa
Position
Academic Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Hai-Almudafeen
City
Kerbala
Province
Hai-Almudafeen
Postal code
56001
Phone
56001
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 scale that measures patients ’dysphagia levels in both the control group and intervention group.
When the data will become available and for how long
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 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 abd alzahraa is the correspoding author.
What processes are involved for a request to access data/document
Users can ask for the data and permission via email.Hawraa Al-Hesnawi is the corresponding author