Protocol summary

Study aim
To improve the level of dyspnea, SPO2, and RR among patients with asthma
Design
An Quasi-expermental (non-equevelant ) design will be done to assess the asthmatic-induced dyspnea . and the minimum sample size for each group will be 30 as calculated based on the confidence level of 80% and 5% margin of error. The total sample size would be 90 subjects.
Settings and conduct
Imam hussain medical city
Participants/Inclusion and exclusion criteria
• patient diagnosed with asthma. • male and female . Exclusion Criteria: • Children under 12 years old. • Elderly people with asthma who cannot tolerate the previous mentioned positions. • Individuals with intellectual disabilities, dementia or mental health disorders. • Patients with severe cardiopulmonary cases such as COPD or heart failure. • Pregnant women. • Patients with fever.
Intervention groups
The study measures respiratory conditions, including oxygen saturation, respiratory rate, and dyspnea, in 30 patients. The first experimental group (tripod position) performs pursed lip breathing exercises three times, followed by a 5-minute rest period. The second group (prostrate position) performs the same exercise three times, followed by a 5-minute rest period. The control group (control) follows traditional hospital interventions without intervention. The respiratory status is measured and re-evaluated after 10 minutes for comparison.
Main outcome variables
improving in dyspnea and pulmonary parameters in asthmatic patients

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220706055390N1
Registration date: 2025-03-05, 1403/12/15
Registration timing: prospective

Last update: 2025-03-05, 1403/12/15
Update count: 0
Registration date
2025-03-05, 1403/12/15
Registrant information
Name
Haider Nawaf
Name of organization / entity
Kerbala health directorate / al hussain medical city
Country
Iraq
Phone
+964 771 857 5181
Email address
haider84nawaf@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-03-15, 1403/12/25
Expected recruitment end date
2025-05-15, 1404/02/25
Actual recruitment start date
2025-03-20, 1403/12/30
Actual recruitment end date
2025-05-31, 1404/03/10
Trial completion date
2025-08-01, 1404/05/10
Scientific title
Effect of Combination of Different Postures and Pursed Lips Breathing on Dyspnea and Pulmonary Parameters among Patients with Asthma
Public title
Effect of tripod and prostrate on Dyspnea and Pulmonary Parameters among Patients with Asthma
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
A hospitalized patient who were already diagnosed with asthma have dyspnea • Both male and female sex
Exclusion criteria:
Children under 12 years old. Elderly people with asthma who cannot tolerate the previous mentioned positions ndividuals with intellectual disabilities, dementia or mental health disorders. Patients with severe cardiopulmonary cases such as COPD or heart failure Pregnant women Patients with fever
Age
From 18 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Actual sample size reached: 90
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 collage of nursing / babylon university
Street address
iraq- karbala city
City
karbala
Postal code
51001
Approval date
2025-02-01, 1403/11/13
Ethics committee reference number
150

Health conditions studied

1

Description of health condition studied
dyspnea in asthmatic patient
ICD-10 code
J45
ICD-10 code description
Asthma

Primary outcomes

1

Description
improving dyspnea and pulmonary in asthmatic patient
Timepoint
10 minnutes after intervention
Method of measurement
binary scale for dyspnea and obsevation for pulmonary parameters

Secondary outcomes

empty

Intervention groups

1

Description
The first experimental group (tripod position) :- The study measures respiratory conditions, including oxygen saturation, respiratory rate, and dyspnea, in 30 patients before the patients perform pursed lip breathing exercises three times, followed by a 5-minute rest period in tripod position and back to perform pursed lip breathing exercises three times and again measures its.
Category
Treatment - Other

2

Description
The second experimental group (prostrate position) :- The study measures respiratory conditions, including oxygen saturation, respiratory rate, and dyspnea, in 30 patients before the patients perform pursed lip breathing exercises three times, followed by a 5-minute rest period in tripod position and back to perform pursed lip breathing exercises three times and again measures its.
Category
Treatment - Other

3

Description
Control group:The control group (control) follows traditional hospital interventions without intervention. The respiratory status is measured and re-evaluated after 10 minutes for comparison.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
imam al - hussain medical city
Full name of responsible person
karbala Health Directorate
Street address
imam al abbas street
City
karbala
Postal code
56001
Phone
+964 771 857 5181
Email
hayder.nawaf@s.uokerbala.edu.iq

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
babylon university / collage of nursing
Full name of responsible person
Shatha sadi mohammed
Street address
street 40
City
bablyon
Postal code
51001
Phone
+964 770 808 2624
Email
nur.shatha.sadeli@uobabylon.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
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
babylon university / collage of nursing
Full name of responsible person
Shatha sadi mohammed
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
adult nursing
Street address
street 40
City
bablyon
Province
babylon
Postal code
51001
Phone
+964 770 808 2624
Email
nur.shatha.sadeli@uobabylon.edu.iq

Person responsible for scientific inquiries

Contact
Name of organization / entity
babylon university / collage of nursing
Full name of responsible person
Shatha sadi mohammed
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
adult nursing
Street address
street 40
City
bablyon
Province
babylon
Postal code
51001
Phone
+964 770 808 2624
Email
nur.shatha.sadeli@uobabylon.edu.iq

Person responsible for updating data

Contact
Name of organization / entity
babylon university / collage of nursing
Full name of responsible person
Shatha sadi mohammed
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
adult nursing
Street address
street 40
City
bablyon
Province
babylon
Postal code
51001
Phone
+964 770 808 2624
Email
nur.shatha.sadeli@uobabylon.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 asthmatic patients improvement that measure patients' dyspnea and pulmonary parameters in both control and interventions 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 post grduate student, 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 the permission via email. Also, users need to acknowledge the owner
From where data/document is obtainable
Users can ask for the data and the permission via email. Dr. haider is the corresponding author. He will be in contact with whom ask for the data. His email haider84nawaf@gmail.com. Dr haider works at imam al - hussain medical city
What processes are involved for a request to access data/document
Users can ask for the data and the permission via email. Dr. haider is the corresponding author. He will be in contact with whom ask for the data. His email is haider84nawaf@gmail.com.
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