Protocol summary

Study aim
Determining the effect of semi-sitting position (group A (, tripod (group B)) and lower back (group C) on vital signs and comfort pattern in patients with COVID19
Design
In this clinical trial, 90 eligible patients will be selected and placed in three groups A, B, C. This study will be performed on three groups, one control group and two intervention groups. The study is double-blind with parallel groups, randomized. In this study, phase is not applicable. Rand function in Excel software will also be used for randomization.
Settings and conduct
This study will be performed in Amir Al-Momenin Hospital in Arak. Participants' expert and sample collector do not know how to randomize.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Infection by coronavirus (positive PCR test), age 20 to 70 years, willingness to participate in research, lack of connection to a mechanical ventilator (no intubation), ability to communicate, no underlying respiratory disease, no pregnancy, No history of abdominal surgery during the last 6 months (for placement in the lumbar position), having lung involvement of at least 10% with shortness of breath Exclusion criteria: patient death, unwillingness to participate in further research, patient intubation during research, abdominal obesity, abdominal surgery recently
Intervention groups
Patients admitted to corona wards to measure the effect of three semi-sitting , tripod and prone positions on vital signs and patients' comfort pattern.
Main outcome variables
Improve vital signs and comfort pattern

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171203037733N3
Registration date: 2021-05-11, 1400/02/21
Registration timing: prospective

Last update: 2021-05-11, 1400/02/21
Update count: 0
Registration date
2021-05-11, 1400/02/21
Registrant information
Name
Mehran Akbari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3505
Email address
m.akbari@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-20, 1400/02/30
Expected recruitment end date
2022-05-20, 1401/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of three tripod, Semi-sitting and prone positions on vital signs and comfort pattern of patients with covid-19
Public title
The effect of body position on vital signs and comfort pattern of patients with coronary disease
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Infection with Corona virus (positive PCR test) Age 20 to 70 years Willingness to participate in research No connection to mechanical ventilation (no intubation) Ability to communicate No underlying respiratory disease No pregnancy No history of abdominal surgery during the last 6 months (for placement in the lumbar position) Have at least 10% lung involvement with shortness of breath
Exclusion criteria:
Patient death Reluctance to participate in further research Intubation of the patient during the research Abdominal obesity Abdominal surgery recently
Age
From 20 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Investigator
  • Data analyser
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
First, patients are selected easily and entered into the study. They will then be randomly assigned (Simple randomized block assignment) to three groups A, B and C By statistical software. Control group A in a semi-sitting position Intervention group B in tripod position Intervention group C in the prone position Rand function in Excel software will also be used for randomization.
Blinding (investigator's opinion)
Double blinded
Blinding description
This research is a clinical trial with three groups (two intervention groups and one control group) that the method of blinding in this study is double-blind that the main researcher and statistical analyzer have been blinded. In this way, the relevant checklists are coded according to codes B, A and C, and the sampler puts people in different positions according to randomly selected codes, and after collecting information by the sampler, this The information is entered by the data analyzer in SPSS statistical software and after extracting the obtained results, accurate analysis can be reported.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Khomein University of Medical Sciences
Street address
Azadi St., Khomein University of Medical Sciences
City
Khomein
Province
Markazi
Postal code
38817-43364
Approval date
2021-05-01, 1400/02/11
Ethics committee reference number
IR.KHOMEIN.REC.1400.001

Health conditions studied

1

Description of health condition studied
coronavirus
ICD-10 code
RA01.0
ICD-10 code description
Covid-19

Primary outcomes

1

Description
Vital signs
Timepoint
Before and after the intervention
Method of measurement
Heart rate, blood pressure and respiration rate

2

Description
Comfort
Timepoint
Before and after the intervention
Method of measurement
Based on the Kolcaba questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group1: This group of patients is in group B, which is in the tripod position. Questionnaires related to demographic information, vital signs and patients' comfort level are completed before the intervention. Group B patients are placed in a tripod position and within 15 and 60 minutes, the patient's vital signs and comfort pattern are re-evaluated and recorded in the relevant questionnaire.
Category
Other

2

Description
Intervention group2: This group of patients is in group C, which is in the prone position. Questionnaires related to demographic information, vital signs and patients' comfort level are completed before the intervention. Group C patients are placed in the prone position and within 15 and 60 minutes, the patient's vital signs and comfort pattern are re-evaluated and recorded in the relevant questionnaire.
Category
Other

3

Description
Control group: Patients in group A are classified as patients in the control group who complete questionnaires related to demographic information, vital signs and patient comfort before the intervention. Group A patients are placed in a semi-sitting position with an angle of 30 degrees and within 15 and 60 minutes, the patient's vital signs and comfort pattern are re-evaluated and recorded in the relevant questionnaire.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Amir Al-Momenin Hospital in Arak
Full name of responsible person
Mehran Akbari
Street address
Azadi St., Khomein School of Medical Sciences, Khomein, Iran
City
Khomein
Province
Markazi
Postal code
38817-43364
Phone
+98 86 4622 1534
Email
mehranakbari1373@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Khomein University of Medical Sciences
Full name of responsible person
Mojtaba Didehdar
Street address
Azadi St., Khomein School of Medical Sciences, Khomein, Iran
City
Khomein
Province
Markazi
Postal code
38817-43364
Phone
+98 86 4622 4142
Email
mehranakbari1373@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khomein 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
Khomein university of Medical Sciences
Full name of responsible person
Mehran Akbari
Position
instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Azadi St., Khomein School of Medical Sciences, Khomein, Iran
City
Khomein
Province
Markazi
Postal code
38817-43364
Phone
+98 86 4622 1534
Email
mehranakbari1373@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Khomein University of Medical Sciences
Full name of responsible person
Mehran Akbari
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Azadi St., Khomein School of Medical Sciences
City
Khomein
Province
Markazi
Postal code
38817-43364
Phone
+98 86 4622 1534
Email
mehranakbari1373@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mehran Akbari
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Azadi St., Khomein School of Medical Sciences
City
Khomein
Province
Markazi
Postal code
38817-43364
Phone
+98 86 4622 1534
Email
mehranakbari1373@yahoo.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
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