Determining the combined effect of deep breathing and prone position on common respiratory symptoms in patients with COVID-19
Design
Clinical trial without control group, with parallel, randomized groups, 96 patients
Settings and conduct
Approval of the ethics committee. Complete the informed consent form. First, complete a checklist of demographic characteristics and measure the Dyspnea with the Visual Analog Scale and the Borg's Scale. Measurement of Blood oxygen saturation level using pulse oximetry and measurement of respiration and cough using a checklist prepared by the researcher. Then, immediately after the interventions, re-measure the Dyspnea using the analog visual scale and the Borg's Scale.The intervention site is the corona ward of Shahid Jalil Hospital in Yasuj.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1- Ability to communicate and answer questions 2- Satisfaction to participate in the study and sign the form of informed consent Inclusion criteria: 1- Patient dissatisfaction with the continuation of the study
Intervention groups
Deep Breathing Intervention Group: The training will be done face to face and numbers will be used to maintain the time-to-exhalation ratio. The training will last for 10 minutes.
prone position intervention group: Patients will first be in the supine position for 30 minutes. The patient will then lie on his stomach or back for 30 minutes and the respiratory symptoms will be re-measured at 15 and 30 minutes and their average will be recorded as desired.
Combined intervention group deep breathing and prone position: The intervention in the group of deep breathing and supine position will be combined.
Main outcome variables
Dyspnea, Cough, Breathing and Blood oxygen saturation level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210423051056N1
Registration date:2021-06-18, 1400/03/28
Registration timing:registered_while_recruiting
Last update:2021-06-18, 1400/03/28
Update count:0
Registration date
2021-06-18, 1400/03/28
Registrant information
Name
Sima Alipour Nasrabadsofla
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3333 7001
Email address
kianoosh.a1381wolf@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-22, 1400/03/01
Expected recruitment end date
2021-07-23, 1400/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The combined effect of deep breathing and prone position on common respiratory symptoms in patients with COVID-19
Public title
The combined effect of deep breathing and prone position on common respiratory symptoms in patients with COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 to 85 years
Ability to communicate and answer questions
Consent to participate in the study and sign the informed consent form
The patient is alert
The patient should not be intubated
The percentage of oxygen saturation of the patient's blood is below 93%
Exclusion criteria:
Patient dissatisfaction with continuing the study
Adverse changes in vital signs (blood oxygen saturation level, heart rate, respiration and blood pressure)
Age
From 18 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Block random allocation will be done in such a way that according to the number of study groups (three groups) including intervention 1 (deep breathing), intervention 2 (prone position) and intervention 3 (combination of deep breathing and prone position) And according to the calculated factorial law, ie 6 = 1 + 2 + 3 =! 3, all possible arrangements of individuals considering A for the intervention group 1 (deep breathing), B for the intervention group 2 (prone position) And C will be developed for intervention group 3 (combination of deep breathing and prone position).
Then, since the estimated sample size was 96 people, in each block, three samples, each of which represents a study group and their order of arrangement will be different, from these blocks, sampling will be done by placement.
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 Yasuj University of Medical Sciences
Street address
Yasuj University of Medical Sciences, Shahid Motahari Blvd., Yasuj, Kohgiluyeh and Boyer-Ahmad, Islamic Republic of Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Approval date
2021-05-15, 1400/02/25
Ethics committee reference number
IR.YUMS.REC.1400.024
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
u07.1
ICD-10 code description
U07.1: COVID-19, Virus identified
Primary outcomes
1
Description
Dyspnea
Timepoint
Patients' rate of Dyspnea at the beginning of the study (before the intervention) and immediately after the start of the study
Method of measurement
Borg's Category Ratio Scale ( CR10 ) and Visual Analog Scales ( VAS)
2
Description
Cough
Timepoint
Number of patients coughing at the beginning of the study (before the intervention) and immediately after the start of the study
Method of measurement
Record the number of coughs using a checklist prepared by the researcher
3
Description
Breathing
Timepoint
The number of patients breathing at the beginning of the study (before the intervention) and immediately after the start of the study
Method of measurement
Record the number of breathing using a checklist prepared by the researcher
4
Description
Blood oxygen saturation level
Timepoint
Percentage of blood oxygen saturation of patients at the beginning of the study (before the intervention) and immediately after the start of the study
Method of measurement
Pulse oximeter connected to the monitor model LK88
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: deep breathing: This intervention will be taught individually and orally by the researcher. In this way, the patient will be asked to perform the inhalation and exhalation operation in a ratio of 4 to 6, ie the inhalation operation through the nose and counting 1 to 4, and the exhalation operation through the mouth and counting 1 to 6. This training will be done face to face and numbers will be used to maintain the time to exhale ratio. A written guide will also be provided to patients. The training will last for 10 minutes and includes; 1. Place your tongue motionless in the palm of your mouth. 2. Breathe slowly and deeply and regularly (deep and slow inhale, exhale, rest.) And 3. Do not talk during the procedure, it will be. The skill of the samples in performing the exercises will be evaluated by the researcher and after training the patient will be asked to practice this task in order to achieve sufficient skills in this field.
Category
Treatment - Other
2
Description
Intervention group 2: prone position: The procedure for performing the intervention in the supine group will be that the patients will first be in the supine position for 30 minutes and before changing the position, the respiratory symptoms will be measured and recorded. The patient will then lie on his stomach or back for 30 minutes and the respiratory symptoms will be re-measured at 15 and 30 minutes. For more accuracy, respiratory symptoms will be measured 3 times at 15-second intervals each time the measurement will be recorded as the desired value.
Category
Treatment - Other
3
Description
Intervention group 3: combination of deep breathing and prone position: The intervention will be performed in the group of deep breathing and supine position in combination, as in the previous two groups and in combination.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Jalil Hospital
Full name of responsible person
Sima Alipour Nasrabadsofla
Street address
Shahid Jalil Hospital, Qarani Blvd., Yasuj, Kohgiluyeh and Boyer-Ahmad, Islamic Republic of Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591387493
Phone
+98 74 3333 7001
Email
simaalipour90@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Hossein Mari Oryad
Street address
Yasuj University of Medical Sciences, Shahid Motahari Blvd., Yasuj, Kohgiluyeh and Boyer-Ahmad, Islamic Republic of Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 1333 7251
Fax
+98 74 3333 7230
Email
nursing@yums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Sima Alipour Nasrabadsofla
Position
Master student of Medical-Surgical Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Jalil Hospital, Qarani Blvd., Yasuj, Kohgiluyeh and Boyer-Ahmad, Islamic Republic of Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591833769
Phone
+98 74 3333 7001
Email
simaalipour90@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Sima Alipour Nasrabadsofla
Position
Master student of Medical-Surgical Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Jalil Hospital, Qarani Blvd., Yasuj, Kohgiluyeh and Boyer-Ahmad, Islamic Republic of Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591833769
Phone
+98 74 3333 7001
Email
simaalipour90@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Sima Alipour Nasrabadsofla
Position
Master student of Medical-Surgical Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Jalil Hospital, Qarani Blvd., Yasuj, Kohgiluyeh and Boyer-Ahmad, Islamic Republic of Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591833769
Phone
+98 74 3333 7001
Email
simaalipour90@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