Determining the effectiveness of respiratory-physical exercises on fatigue and quality of life of nurses caring for COVID-19 patients in the intensive care unit
Design
This is a clinical trial study in which samples are selected by convenience sampling method and then divided into two groups of experimental and control by block randomization method.
Settings and conduct
Study place: Amir Al-Momenin Hospital. Assignment of samples into two groups of intervention and control; then the severity of fatigue and quality of life are measured using the Nurses' Severity of Fatigue Scale and the World Health Organization Quality of Life Questionnaire. Then, the samples in the intervention group are given respiratory-physical movements and exercises in such a way that for 4 weeks and 3 times a week for 35 minutes of respiratory-physical movements and exercises, including: 10 minutes of respiratory exercises, 10 minutes of exercises. Physically and at the end of 15 minutes is Benson's relaxation technique.
Participants/Inclusion and exclusion criteria
At least 6 months of work experience in the intensive care unit; employed as a nursing team in intensive care units of coronary patients; no participation in yoga and meditation preparation courses; consent to participate in the study; no movement limiting diseases, musculoskeletal disorders, heart and respiratory diseases, neurological and psychiatric diseases. Exclusion criteria: cancellation of study at any stage; not doing exercises less than 2 times a week.
Intervention groups
Intervention: physical breathing exercises in which members of the intervention group perform physical breathing movements twice a week for 35 minutes for 4 weeks. The control group does not do any exercises.
Main outcome variables
Fatigue and Quality of Life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210310050663N1
Registration date:2021-05-31, 1400/03/10
Registration timing:registered_while_recruiting
Last update:2021-05-31, 1400/03/10
Update count:0
Registration date
2021-05-31, 1400/03/10
Registrant information
Name
ahmad darvishi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3465 6270
Email address
a.darvishi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-21, 1400/02/01
Expected recruitment end date
2021-06-22, 1400/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of respiratory-physical exercises on fatigue and quality of life of nurses caring for COVID-19 patients in the Intensive Care Unit
Public title
The effect of respiratory-physical exercises on fatigue and quality of life
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
At least 6 months of work experience in the intensive care unit, working as a nursing team (nursing, nursing assistant, nursing associate, nursing expert, master or doctoral nurse) in the intensive care unit where coronary patients are hospitalized
Have not attended yoga and meditation preparation classes
Satisfaction with participation in the study
No known limiting motor diseases, musculoskeletal disorders, heart and respiratory diseases, neurological and psychiatric diseases
Exclusion criteria:
Withdrawal at any stage
Complications of yoga movements
Do not do exercises less than 2 times a week
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization, research units are divided into two groups of intervention and test using block method by random allocation, so that in terms of age, sex, level of education and work experience in the intensive care unit of patients with Covid 19 are homogeneous. For this purpose, first, according to the variables that need to be homogenized, the class is considered for all possible situations of the research units, and after assigning the code to the nurses, it is placed in the block equivalent to their characteristics. Then, the first person of each block is randomly placed in one of the research groups, and each of the next people of each block, according to the characteristics they have about the variables considered for homogenization, is placed in a group with which people There are fewer features in that group.
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 of Arak University of Medical Sciences
Street address
Basij Square of Arak University of Medical Sciences
City
Arak
Province
Markazi
Postal code
38481-70002
Approval date
1993-05-17, 1372/02/27
Ethics committee reference number
IR.ARAKMU.REC.1399.328
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID19,virus identified
Primary outcomes
1
Description
Fatigue score in the Rasooli Nurses Fatigue Questionnaire
Timepoint
At the beginning of the study then after the end of the intervention
Method of measurement
Rasooli Nurses Fatigue Questionnaire
2
Description
Nurses' quality of life score based on the World Health Organization quality of life questionnaire
Timepoint
At the beginning of the study then after the end of the intervention
Method of measurement
World Health Organization quality of life questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group, respiratory-physical exercises are performed twice a week for 4 weeks and 35 minutes each time.
Category
Behavior
2
Description
Control group: No special intervention is performed on the control group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Al-Momenin Hospital
Full name of responsible person
Ahmad Darvishi
Street address
Amir Al-Momenin Hospital, Basij Square
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3601
Email
it-amiralmomenin@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Alireza Kamali
Street address
Basij Square of Arak University of Medical Sciences
City
Arak
Province
Markazi
Postal code
3848176593
Phone
+98 86 3417 3502
Email
alikamaliir@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
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
Arak University of Medical Sciences
Full name of responsible person
Ahmad Darvishi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Arak University of Medical Sciences, Basij Square
City
Arak
Province
Markazi
Postal code
38481-70002
Phone
+98 86 3417 3505
Email
ahmaddarvishi009@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Ahmad Darvishi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Arak University of Medical Sciences, Basij Square
City
Arak
Province
Markazi
Postal code
38481-70002
Phone
+98 86 3417 3505
Email
ahmaddarvishi009@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Ahmad Darvishi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Arak University of Medical Sciences, Basij Square
City
Arak
Province
Markazi
Postal code
38481-70002
Phone
+98 86 3417 3505
Email
ahmaddarvishi009@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
Information about the findings of nurses' fatigue and quality of life questionnaires
When the data will become available and for how long
Access period starts 3 months after the results are published
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
Requests can be sent via existing email.
From where data/document is obtainable
To receive the documents, send a request to the e-mail of Mr. Ahmad Darvishi.
What processes are involved for a request to access data/document
The request will be answered immediately after sending the request and reviewing it.