Determining the effect of using a hand-held fan on dyspnea in decompensated heart failure patients
Design
This study is a randomized clinical trial study without blinding with a control group, in which 60 patients were selected by available sampling method and divided into two groups by random block method.
Settings and conduct
This study is conducted on patients diagnosed with heart failure who were admitted to the internal and CCU departments of Amir-al-Mominin Hospital in Arak. In the intervention group, in addition to the usual care for heart failure patients, including semi-sitting position, and prescription drugs, a hand fan will be used for 5 minutes. In the control group, the usual care of heart failure patients will be performed. Dyspnea severity score will be measured using the Borg scale. This study will be done without blinding.
Participants/Inclusion and exclusion criteria
Inclusion criteria: arterial blood oxygen saturation level of more than 85% and stable hemodynamic conditions. Exclusion criteria: the occurrence of complications (such as the patient's cardiac or respiratory arrest and a drop in the patient's saturation by at least 5% of the baseline level); history of respiratory allergy, COPD and lung cancer.
Intervention groups
In the intervention group, in addition to the usual care for heart failure patients, including oxygen therapy, semi-sitting position, and prescription drugs, a hand-held fan will be used for 5 minutes. In the control group, the usual care of heart failure patients will be performed.
Main outcome variables
The severity of dyspnea is measured according to Borg's numerical scale.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240701062292N1
Registration date:2024-07-16, 1403/04/26
Registration timing:prospective
Last update:2024-07-16, 1403/04/26
Update count:0
Registration date
2024-07-16, 1403/04/26
Registrant information
Name
Sajad Rafiee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3485 0855
Email address
s.rafiei@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-22, 1403/05/01
Expected recruitment end date
2024-10-22, 1403/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Hand-held fan on dyspnea in Decompensated heart failure patients
Public title
The effect of hand-held fan on Dyspnea
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having heart failure
Ability to speak Persian
Having normal hemodynamic conditions
Exclusion criteria:
Inability to communicate properly
Lack of awareness of time and place
Suffering from mental illnesses
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The patients were selected based on the inclusion and exclusion criteria and were placed in two intervention and control groups using a random block method consisting of 6 blocks of 10. The software is used to assign patients to the intervention groups indicated by the letter A and the control group indicated by the letter B. Letters (A) and (B), according to the order in the list of letters, are placed in envelopes that are sequentially numbered and indistinguishable. After selecting the patient, the envelope related to that patient is opened and based on the English letter inside the envelope, the patient is assigned to the study group.
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
A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, Iran
City
Arak
Province
Markazi
Postal code
3819693345
Approval date
2024-06-16, 1403/03/27
Ethics committee reference number
IR.ARAKMU.REC.1403.126
Health conditions studied
1
Description of health condition studied
Dyspnea
ICD-10 code
R06.02
ICD-10 code description
Shortness of breath
2
Description of health condition studied
Heart failure
ICD-10 code
I50
ICD-10 code description
Heart failure
Primary outcomes
1
Description
Shortness of Breath Severity Score in the Borg Scale
Timepoint
Measuring the severity of dyspnea before the intervention and immediately after the intervention
Method of measurement
Dyspnea Borg Scale
Secondary outcomes
1
Description
Breaths per minute
Timepoint
Measuring the number of breaths per minute before the intervention and immediately after the intervention
Method of measurement
Variable measurement will be done by the researcher and by observation.
2
Description
Oxygen saturation level of arterial blood
Timepoint
Measurement of arterial blood oxygen saturation level before the intervention and immediately after the intervention
Intervention group: The intervention group will receive the usual care of heart failure patients, including the use of oxygen, monitoring, semi-sitting position, receiving inotrope or diuretic drugs and other prescription drugs based on the order of the attending physician. The present study does not create a disturbance in the normal care of patients. If the arterial blood oxygen saturation level is more than 85%, nasal cannula can be used for oxygen therapy. For patients in the intervention group, after measuring the severity of dyspnea, in addition to the prescribed treatments, a hand-held fan will be used for 5 minutes. The fan will be set at a distance of 15 to 30 cm and with a speed of 5 km/h, so that it is directly in front of the patient's face. Immediately after the intervention, the dyspnea score will be measured and recorded again in the same way as it was done in the beginning.
Category
Treatment - Other
2
Description
Control group: In the patients of the control group, first the severity of dyspnea was measured and the patients were treated for 5 minutes with standard care including the use of oxygen, monitoring, semi-sitting position, receiving inotrope or diuretic drugs and other prescription drugs. After 5 minutes, the severity of dyspnea of the patients will be measured and the resulting data will be subjected to statistical tests for evaluation and comparison.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Al-Momenin Hospital
Full name of responsible person
Ali Sadoogh
Street address
Amir-al-Momenin(A.S) Education and Treatment Center, Basij Square, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3836 0000
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
Davood Hekmatpou
Street address
A'lam-Al-Hoda Street, Shahid Shiroodi Street, Arak, Markazi Province, Iran
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 4501
Email
int.affairs@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
Sajad Rafiee
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Paradise Apartment, Seven Niloofar Ave, Ostad Mahdi Blvd, One Pardis Town, Arak City
City
Arak
Province
Markazi
Postal code
3817648296
Phone
+98 86 3485 0855
Email
s.rafiei@arakmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Korosh Rezaei
Position
Nursing Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Prophet Azam University Complex, Basij Square, Arak City
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3540
Email
rezaeikorosh0@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Sajad Rafiee
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Paradise Apartment, Seven Niloofar Ave, Ostad Mahdi Blvd, One Pardis Town, Arak City
City
Arak
Province
Markazi
Postal code
3817648296
Phone
+98 86 3485 0855
Email
s.rafiee@arakmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Demographic characteristics, dyspnea severity score and secondary variables (including number of breaths per minute, arterial blood oxygen saturation level and heart rate per minute)
When the data will become available and for how long
Start the access period 6 months after the publication of
the results.
To whom data/document is available
All individuals can access the information.
Under which criteria data/document could be used
Nothing
From where data/document is obtainable
Korosh Rezaei; k.rezaei@arakmu.ac.ir; Arak University of
Medical Sciences; 00989183677622.
What processes are involved for a request to access data/document