To assess the impact of the prone position on dyspnea and physiological indices in pneumonia patients
Design
This is a single-blind randomized clinical trial with a control group with parallel groups, in which eligible patients will be randomly assigned to the intervention and control groups using block randomization.
Settings and conduct
This study will be conducted at the Sina Hospital in Hamadan city, involving 84 eligible patients with pneumonia. The patients will be randomly assigned to the intervention and control groups through the block randomization. This trial will be single-blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 18 to 75 years
Mild to moderate pneumonia
Mild to moderate arterial oxygen saturation 80 to 90%
Exclusion criteria:
Pregnancy
Requirement of intubation
Intolerance to mask
Presence of abdominal wound or spinal and neck disorder
Heart disease or hypertension
Intervention groups
Intervention group:
Routine treatment plus non-invasive ventilation with a simple mask or a resuscitator bag mask without rebreathing of exhaled air at a flow rate of 6 to 10 liters per minute in the prone position
Control group:
Routine treatment plus non-invasive ventilation with a simple mask or a resuscitator bag mask without rebreathing of exhaled air at a flow rate of 6 to 10 liters per minute in the supine position
Main outcome variables
Primary outcome:
Dyspnea; Respiration rate per minute; Heart rate per minute; Systolic and diastolic blood pressure; Blood oxygen saturation (SPO2)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N555
Registration date:2025-04-18, 1404/01/29
Registration timing:prospective
Last update:2025-04-18, 1404/01/29
Update count:0
Registration date
2025-04-18, 1404/01/29
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
recruiting
Funding source
Expected recruitment start date
2025-05-02, 1404/02/12
Expected recruitment end date
2025-06-02, 1404/03/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of the prone position on dyspnea and physiological indices in pneumonia patients: a single-blind randomized clinical trial
Public title
The impact of the prone position on dyspnea and physiological indices in pneumonia patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 75 years
Mild to moderate pneumonia
Mild to moderate arterial oxygen saturation 80 to 90%
Exclusion criteria:
Pregnancy
Requirement of intubation
Intolerance to mask
Presence of abdominal wound or spinal and neck disorder
Heart disease or hypertension
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, random assignment of patients to the intervention and control groups will be carried out using block randomization. To achieve this, four sheets of paper will be prepared - two with the name of the intervention and two with the name of the control. These paper sheets will be pooled and placed in a container. Patients will be selected one at a time without replacement, and for each patient, a paper sheet will be randomly drawn from the container. After each draw, the paper sheets will be returned to the container, and the process will be repeated until the desired sample size is reached.
Blinding (investigator's opinion)
Single blinded
Blinding description
The analyzer responsible for evaluating the trial's results will also be kept blind to the type of interventions. Therefore, the trial will be conducted as a single-blind study.
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, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2025-03-15, 1403/12/25
Ethics committee reference number
IR.UMSHA.REC.1403.942
Health conditions studied
1
Description of health condition studied
Pneumonia
ICD-10 code
B95.3
ICD-10 code description
Streptococcus pneumoniae as the cause of diseases classified elsewhere
Primary outcomes
1
Description
Dyspnea
Timepoint
Before intervention and 30, 60, and 90 minutes later
Method of measurement
With visual analog scale (VAS)
2
Description
Respiration rate per minute
Timepoint
Before intervention and 30, 60, and 90 minutes later
Method of measurement
With monitoring device
3
Description
Heart rate per minute
Timepoint
Before intervention and 30, 60, and 90 minutes later
Method of measurement
With monitoring device
4
Description
Systolic and diastolic blood pressure
Timepoint
Before intervention and 30, 60, and 90 minutes later
Method of measurement
With monitoring device
5
Description
Blood oxygen saturation (SPO2)
Timepoint
Before intervention and 30, 60, and 90 minutes later
Method of measurement
With monitoring device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine treatment plus non-invasive ventilation with a simple mask or a resuscitator bag mask without rebreathing of exhaled air at a flow rate of 6 to 10 liters per minute in the prone position
Category
Treatment - Other
2
Description
Control group:Routine treatment plus non-invasive ventilation with a simple mask or a resuscitator bag mask without rebreathing of exhaled air at a flow rate of 6 to 10 liters per minute in the supine position
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital in Hamadan city
Full name of responsible person
Seyed Amir Hosein Ahghar
Street address
Sina Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3827 4184
Email
amiramiry889@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Alireza Soltanian
Street address
Hamadan University of Medical Sciences, 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
Seyed Amir Hosein Ahghar
Position
Nursing Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
amiramiry889@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Arezoo Karampoorian
Position
Disaster and Emergency Health Epecialist
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, Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
Karampor1@yahoo.com
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, 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