. This study aims to examine the effectiveness of slow deep breathing exercises upon fatigue level among patients undergoing chemotherapy.
Design
Aquasi-experimental design
Settings and conduct
The study was conducted at Imam Al-Hussein Oncology and Hematology Center, and the oncology wards at Imam Al-Hassan Al-Mujtaba Teaching Hospital which is located in Holy Kerbala City
Participants/Inclusion and exclusion criteria
inclusion criteria
patients with cancer undergoing chemotherapy.
patients undergoing two cycles of chemotherapy sessions at least.
exclusion criteria
patients don't have fatigue.
patients are unable to communicate.
Intervention groups
patients in the intervention group will performed slow deep breathing through the nose while the mouth was closed and keep it on for few second and then exhale slowly through the mouth. This exercise was performed for 15-20 min twice daily for seven days.
Main outcome variables
fatigue level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230704058668N1
Registration date:2023-07-19, 1402/04/28
Registration timing:retrospective
Last update:2023-07-19, 1402/04/28
Update count:0
Registration date
2023-07-19, 1402/04/28
Registrant information
Name
Zahraa Jasim
Name of organization / entity
University of Kerbala / College of Nursing
Country
Iraq
Phone
+964 782 723 2988
Email address
zahraa.j@s.uokerbala.edu.iq
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-01, 1401/11/12
Expected recruitment end date
2023-04-20, 1402/01/31
Actual recruitment start date
2023-02-01, 1401/11/12
Actual recruitment end date
2023-04-15, 1402/01/26
Trial completion date
empty
Scientific title
Effectiveness of Slow Deep Breathing Exercises upon Fatigue Level among Patients Undergoing Chemotherapy
Public title
Slow Deep Breathing Exercises upon Fatigue Level
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with cancer undergoing chemotherapy.
Patients undergoing two cycles at least
Exclusion criteria:
Patients who don’t have nausea or fatigue.
Patient with impaired verbal communication
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
48
Actual sample size reached:
48
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 University of Karbala
Street address
officers neighborhood, Karbala
City
Karbala city center
Postal code
56001
Approval date
2022-11-03, 1401/08/12
Ethics committee reference number
1502.66
Health conditions studied
1
Description of health condition studied
cancer
ICD-10 code
Y43.3
ICD-10 code description
fatigue as a side effects of chemotherapy
Primary outcomes
1
Description
The primary outcome variable is the level of fatigue related to chemotherapy that can be changed based on slow deep breathing exercise.
Timepoint
Before intervention and after 7 days of intervention
Method of measurement
fatigue severity scale will be used to measure fatigue level
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Appling slow deep breathing through the nose while the mouth was closed and keep it on for few second and then exhale slowly through the mouth. This exercise was performed for 15-20 min twice daily for seven days.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
The study was conducted at Imam Al-Hussein Oncology and Hematology Center, and the oncology wards at
Full name of responsible person
Zahraa Jasim
Street address
family neighboorhood,
City
Karbala city center
Postal code
56001
Phone
+964 782 723 2988
Email
zahraa.j@s.uokerbala.edu.iq
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
university of Karbala
Full name of responsible person
Zahraa Jasim
Street address
officers neighborhood, Karbala
City
Karbala city center
Postal code
56001
Phone
+964 782 723 2988
Email
zahraa.j@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
university of Karbala/ College of nursing
Full name of responsible person
Zahraa Jasim
Position
master student
Latest degree
Bachelor
Other areas of specialty/work
adult Nursing Department
Street address
officers neighborhood, Karbala
City
Karbala city center
Province
Holy Kerbala
Postal code
56001
Phone
+964 782 723 2988
Email
zahraa.j@s.uokerbala.edu.iq
Person responsible for scientific inquiries
Contact
Name of organization / entity
university of Karbala/ College of nursing
Full name of responsible person
Zahraa Jasim Alwan
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Adult nursing
Street address
officers neighborhood, Karbala
City
Karbala city center
Province
Holy Kerbala
Postal code
56001
Phone
+964 782 723 2988
Email
zahraa.j@s.uokerbala.edu.iq
Person responsible for updating data
Contact
Name of organization / entity
University of Karbala/ College of nursing
Full name of responsible person
Zahraa Jasim Alwan
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Nursing
Street address
officers neighborhood, Karbala
City
Karbala city center
Province
Holy Kerbala
Postal code
56001
Phone
+964 782 723 2988
Email
zahraa.j@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
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Effectiveness of Slow Deep Breathing Exercises upon Fatigue Level among Patients Undergoing Chemotherapy
When the data will become available and for how long
the data will be available at the end of July
To whom data/document is available
any researcher who is interested in this 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. Zahraa Jasim Alwan is the corresponding author. He will contact whoever he requests the information from. His email is zahraa.j@s.uokerbala.edu.iq. The address is Al-Hur district, Karbala, Iraq. What processes are involved for a request to access data/document
What processes are involved for a request to access data/document
Users can ask for the data and permission via email. Zahraa Jasim Alwan is the corresponding author. He will contact whoever he requests the information from. His email is zahraa.j@s.uokerbala.edu.iq.