Effect of prone and orthopnea positions versus supine position on comfort, dyspnea and arterial blood oxygen saturation in patients with Covid-19: a randomized clinical trial
Red color represents old content. It may be empty showing addition in the new version.
Green color represents new content. It may be empty showing deletion in the new version.
Inline
Side by side
Added new contents,
deleted old contents,contents that are not changed.
New table contents
New table contents
Old table contents
Old table contents
Unchanged contents
Unchanged contents
Added new contents, contents that are not changed.
Deleted old contents, contents that are not changed.
Old table contents
Old table contents
Unchanged contents
Unchanged contents
New table contents
New table contents
Unchanged contents
Unchanged contents
Protocol summary
این یک مطالعه کارآزمایی بالینی تصادفی شده دارای گروه کنترل می باشد که در آن بیماران واجد شرایط به صورت تصادفي به روش بلوك هاي تصادفي به دو گروه مداخله و کنترل تخصیص داده خواهند شد.
این یک مطالعه کارآزمایی بالینی تصادفی شده دارای گروه کنترل می باشد که در آن بیماران واجد شرایط به صورت تصادفي به روش بلوك هاي تصادفي به گروه های مداخله و کنترل تخصیص داده خواهند شد.
این یک مطالعه کارآزمایی بالینی تصادفی شده دارای گروه کنترل می باشد که در آن بیماران واجد شرایط به صورت تصادفي به روش بلوك هاي تصادفي به دو گروه های مداخله و کنترل تخصیص داده خواهند شد.
This study will be performed in the Fatemieh Hospital in Hamadan city on 90 eligible patients. The patients will be randomly assigned to the intervention and control groups through the block randomization. Blinding is not possible in this study.
This study will be performed in the Golastan Hospital in Kermanshah city on 90 eligible patients. The patients will be randomly assigned to the intervention and control groups through the block randomization. Blinding is not possible in this study.
This study will be performed in the FatemiehGolastan Hospital in HamadanKermanshah city on 90 eligible patients. The patients will be randomly assigned to the intervention and control groups through the block randomization. Blinding is not possible in this study.
این مطالعه در بیمارستان فاطمیه شهر همدان بر روی 90 بیماران مبتلا به کووید-19 انجام خواهد شد. بیماران به صورت تصادفی به روش بلوك هاي تصادفي به گروههای مداخله و کنترل تخصیص داده خواهند. امکان کورسازی در این مطالعه وجود ندارد.
این مطالعه در بیمارستان گلستان شهر کرمانشاه بر روی 90 بیماران مبتلا به کووید-19 انجام خواهد شد. بیماران به صورت تصادفی به روش بلوك هاي تصادفي به گروههای مداخله و کنترل تخصیص داده خواهند. امکان کورسازی در این مطالعه وجود ندارد.
این مطالعه در بیمارستان فاطمیهگلستان شهر همدانکرمانشاه بر روی 90 بیماران مبتلا به کووید-19 انجام خواهد شد. بیماران به صورت تصادفی به روش بلوك هاي تصادفي به گروههای مداخله و کنترل تخصیص داده خواهند. امکان کورسازی در این مطالعه وجود ندارد.
Primary outcome:
Arterial blood pressure, feeling comfortable, the severity of dyspnea
Primary outcome:
Arterial blood oxygen, feeling comfortable, the severity of dyspnea
Primary outcome: Arterial blood pressureoxygen, feeling comfortable, the severity of dyspnea
Primary outcomes
#1
Arterial blood pressure
Arterial blood oxygen
Arterial blood pressureoxygen
فشار خون شریانی
اکسیژن خون شریانی
فشاراکسیژن خون شریانی
By taking arterial blood samples
By using Mark Beurer pulse oximeter model P030 made in Germany
By taking arterial blood samplesusing Mark Beurer pulse oximeter model P030 made in Germany
با گرفتن نمونه خون شریانی
با استفاده از پالس اکسی متری مارک بیور مدل P030 ساخت کشور آلمان
با گرفتن نمونه خون شریانیاستفاده از پالس اکسی متری مارک بیور مدل P030 ساخت کشور آلمان
Recruitment centers
#1
Name of recruitment center - English: Fatemieh Hospital in Hamadan city
Name of recruitment center - Persian: بیمارستان فاطمیه شهر همدان
Full name of responsible person - English: Maryam Rezaei
Full name of responsible person - Persian: مریم رضایی
Street address - English: Fatemieh Hospital, Pasdaran Ave.
Street address - Persian: خیابان پاسداران، بیمارستان فاطمیه
City - English: Hamadan
City - Persian: همدان
Province: Hamadan
Country: Iran (Islamic Republic of)
Postal code: 6517838695
Phone: +98 81 3828 3939
Fax:
Email: mr2701330@gmail.com
Web page address:
Name of recruitment center - English: Golastan Hospital in Kermanshah city
Name of recruitment center - Persian: بیمارستان گلستان شهر کرمانشاه
Full name of responsible person - English: Maryam Rezaei
Full name of responsible person - Persian: مریم رضایی
Street address - English: Golastan Hospital, Boostan Ave.
Street address - Persian: خیابان بوستان، بیمارستان گلستان
City - English: Kermanshah
City - Persian: کرمانشاه
Province: Kermanshah
Country: Iran (Islamic Republic of)
Postal code: 6718743116
Phone: +98 83 3710 6527
Fax:
Email: mr2701330@gmail.com
Web page address:
Name of recruitment center - English: FatemiehGolastan Hospital in HamadanKermanshah city Name of recruitment center - Persian: بیمارستان فاطمیهگلستان شهر همدانکرمانشاه Full name of responsible person - English: Maryam Rezaei Full name of responsible person - Persian: مریم رضایی Street address - English: FatemiehGolastan Hospital, PasdaranBoostan Ave. Street address - Persian: خیابان پاسدارانبوستان، بیمارستان فاطمیهگلستان City - English: HamadanKermanshah City - Persian: همدانکرمانشاه Province: HamadanKermanshah Country: Iran (Islamic Republic of) Postal code: 65178386956718743116 Phone: +98 81 3828 393983 3710 6527 Fax: Email: mr2701330@gmail.com Web page address:
Protocol summary
Study aim
To assess the effect of prone and orthopnea positions versus supine position on comfort, dyspnea and arterial blood oxygen saturation in patients with Covid-19
Design
This is a randomized clinical trial with control group, in which eligible patients will be randomly assigned through the block randomization to the intervention and control groups
Settings and conduct
This study will be performed in the Golastan Hospital in Kermanshah city on 90 eligible patients. The patients will be randomly assigned to the intervention and control groups through the block randomization. Blinding is not possible in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 18 to 60 years;
Covid-19 infection;
Conscious;
Mild to moderate arterial oxygen saturation (80% to 90%);
Exclusion criteria:
Pregnancy;
Obesity;
Abdominal ulcers
Intervention groups
Intervention group 1:
Laying the patient in the prone position for 30 minutes
Intervention group 2:
Laying the patient in the orthopedic position for 30 minutes
Control group:
Laying the patient in the supine position for 30 minutes
Main outcome variables
Primary outcome:
Arterial blood oxygen, feeling comfortable, the severity of dyspnea
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N425
Registration date:2022-05-10, 1401/02/20
Registration timing:prospective
Last update:2022-05-15, 1401/02/25
Update count:1
Registration date
2022-05-10, 1401/02/20
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-22, 1401/03/01
Expected recruitment end date
2022-09-22, 1401/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of prone and orthopnea positions versus supine position on comfort, dyspnea and arterial blood oxygen saturation in patients with Covid-19: a randomized clinical trial
Public title
Effect of prone and orthopnea positions versus supine position on comfort, dyspnea and arterial blood oxygen saturation in patients with Covid-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 60 years;
Covid-19 infection;
Conscious;
Mild to moderate arterial oxygen saturation (80% to 90%);
Exclusion criteria:
Pregnancy;
Obesity;
Abdominal ulcers
Age
From 18 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare six sheets of paper, writing on two sheets the name of the intervention 1 and on two other sheets the name of the intervention 2 and on the third two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all six sheets are drawn. The six paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.
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 Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2022-05-07, 1401/02/17
Ethics committee reference number
IR.UMSHA.REC.1401.134
Health conditions studied
1
Description of health condition studied
Covid-19
ICD-10 code
U07.1
ICD-10 code description
Covid-19
Primary outcomes
1
Description
Arterial blood oxygen
Timepoint
Before the intervention and 10 and 30 minutes after the intervention
Method of measurement
By using Mark Beurer pulse oximeter model P030 made in Germany
2
Description
Feeling comfortable
Timepoint
Before the intervention and 10 and 30 minutes after the intervention
Method of measurement
Using the visual analog scale (VAS)
3
Description
The severity of dyspnea
Timepoint
Before the intervention and 10 and 30 minutes after the intervention
Method of measurement
Using the analog visual analog scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Laying the patient in the prone position for 30 minutes
Category
Treatment - Other
2
Description
Intervention group 2: Laying the patient in the orthopedic position for 30 minutes
Category
Treatment - Other
3
Description
Control group: Laying the patient in the supine position for 30 minutes
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Golastan Hospital in Kermanshah city
Full name of responsible person
Maryam Rezaei
Street address
Golastan Hospital, Boostan Ave.
City
Kermanshah
Province
Kermanshah
Postal code
6718743116
Phone
+98 83 3710 6527
Email
mr2701330@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Reza Shokoohi
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Maryam Rezaei
Position
Student of Nursery
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
mr2701330@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Arezoo Karampourian
Position
Disaster and Emergency Health Specialist
Latest degree
Ph.D.
Other areas of specialty/work
Health in Emergency and Disaster
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
a.karampourian@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
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