Determining the effect of diaphragmatic breathing training on dyspnea and situational anxiety in corona patients.
Design
This study is an interventional study. First, among all patients with covid-19 hospitalized on the day of discharge, sampling is performed using available sampling and taking into account the inclusion criteria.
The samples will be divided into two groups of control and intervention with random allocation (quadruple blocking).
Settings and conduct
This study will be performed in the corona ward of Amir Al-Momenin Hospital in Arak. Intervention group will be wanted to do diaphragmatic breathing for 10 minutes and participants are asked to do this exercise one day after discharge, for one week, once in the morning and once at night each time for 10 minutes. The questionnaires of positional anxiety and shortness of breath and oxygen saturation will be completed by both groups before the intervention, immediately after the intervention and again a week later.
The control group will also receive only routine care.
Participants/Inclusion and exclusion criteria
Entry requirements:
1) corona patients who hospitalized.
2) Spo2 less than 93% .
3) The patient expresses a feeling of shortness of breath.
4) Minimum age 18 years.
5) Fluency and understanding of Persian language.
6) No history of taking anti-anxiety and anti-depressant drugs.
7) No history of chronic coronary and pulmonary disease.
Intervention groups
The day of discharge intervention group will be individually trained by the researcher in diaphragmatic breathing training then they will do it for 10 minutes. One they after discharge they will wanted to do this train 10 minutes for tow times in morning and night till one week.
The control group will also receive only routine care.
Main outcome variables
Anxiety, dyspnea, and spo2 are dependent variables.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211107052988N1
Registration date:2021-11-16, 1400/08/25
Registration timing:registered_while_recruiting
Last update:2021-11-16, 1400/08/25
Update count:0
Registration date
2021-11-16, 1400/08/25
Registrant information
Name
Homa Rastegari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3328 7185
Email address
homa.rst96@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-07, 1400/08/16
Expected recruitment end date
2022-01-06, 1400/10/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of diaphragmatic breathing training on dyspnea and anxiety of patient with Covid-19.
Public title
Effect of diaphragmatic breathing training on dyspnea and anxiety of patient with Covid-19.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All of the covid-19 patient in Amir-Al-momenin hospital in Arak city on the day of discharge.
SPO2 less than 93%.
Expressing feeling of shortness of breath.
Minimum age 18 years old.
Fluency and understanding of Persian language.
No history of taking anti-anxiety and anti-depressant drugs.
No history of having chronic coronary and pulmonary disease.
Exclusion criteria:
Reluctance to continue cooperation.
Do not do breathing exercises for one shift or more.
Incidence of acute and severe respiratory distress.
Existence of mental and cognitive problems.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
78
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be divided into two groups of control and intervention with random allocation (quadruple permuted block). In this way, in each block of 4, two allocations to the intervention group and two allocations to the control group are considered And there are 6 cases in total, then the lottery is done by placement and each group that is selected, the sequence of participants (intervention and control) is determined.
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
Sardasht, Payambar Azam University Complex, office building
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2021-10-25, 1400/08/03
Ethics committee reference number
IR.ARAKMU.REC.1400.189
Health conditions studied
1
Description of health condition studied
covid-19
ICD-10 code
B34.2
ICD-10 code description
Coronavirus infection, unspecified
Primary outcomes
1
Description
Situational Anxiety
Timepoint
Before the intervention, immediately after the intervention and one week after.
Method of measurement
Spielberg Situational Anxiety Questionnaire
2
Description
dyspnea
Timepoint
Before the intervention, immediately after the intervention and one week after.
Method of measurement
Borg scale for dyspnea, puls oximetry dvice, modified medical research council scale for dyspnea.
Secondary outcomes
empty
Intervention groups
1
Description
The "intervention group" on the day of discharge will be individually trained by the researcher in diaphragmatic breathing. They will then be asked to do this exercise for 10 minutes and the relevant questionnaires will be completed before and after this period.The "intervention group" is then asked to do this exercise for 10 minutes from the morning one day after discharge for one week, once in the morning and once in the evening, and again after a week the relevant questionnaires. Will be completed and compared and analyzed.
Category
Rehabilitation
2
Description
Control group: The "control group" in this study will receive only routine care and will not receive diaphragmatic training. However, they will complete the questionnaires 3 times together with the intervention group and will finally be compared and analyzed.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir-Al-Momenin Hospital
Full name of responsible person
Homa Rastegari
Street address
Sardasht, Basij Square, Amir-Al-Momenin hospital.
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
Seyed Mohammad Jamaliyan
Street address
Sardash, Payambar Azam university complex, Arak university of medical sciences
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3524
Email
nursing.school@arakmu.ac.ir
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
Homa Rastegari
Position
Master's student of medical-surgical nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Sardasht, Payambarazam University complex, nursing school
City
Arak
Province
Markazi
Postal code
3847176941
Phone
+98 86 3417 3524
Email
homa.rst96@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Homa Rastegari
Position
Master's student in medical-surgical nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 8833, MazidAbadi alley., laali Ave
City
Arak
Province
Markazi
Postal code
3814768833
Phone
+98 86 3328 7185
Fax
Email
homa.rst96@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Homa Rastegari
Position
Master's student in medical-surgical nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 8833, MazidAbadi alley., laali Ave
City
Arak
Province
Markazi
Postal code
3814768833
Phone
+98 86 3328 7185
Fax
Email
homa.rst96@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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