This study is a clinical trial to determine the effect of rhythmic breathing on the chest pain and cardiorespiratory parameters in patients with acute coronary syndrome (ACS) admitted to cardiac care unit (CCU). The study sample consist of 112 patients diagnosed with acute coronary syndrome and the inclusion criteria are: (ACS definitive diagnosis by the cardiologist; the lack of critical state of health; etc). The subjects will be selected of the CCU CHAMRAN hospital in Tehran in 2014 and will be randomized into intervention and control groups. The demographic and disease questionnaire will be completed for each patient. The intervention group will do the rhythmic breathing for twenty minutes every five minutes once and it will take a minute. In this way that the patient with closed eyes will be supine state and with counting numbers 1, 2 and 3 will enter air through the nose into the lungs, then by counting 1, 2 and 3 will keep the air in their lungs and finally, by counting 1, 2 and 3 will out the air through the mouth. Within twelve hours of admission to hospital, if chest pain occurs, in both groups the pain intensity will be measured by the McGill questionnaire and cardiorespiratory parameters will be monitored too.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201411097225N2
Registration date:2014-12-15, 1393/09/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-12-15, 1393/09/24
Registrant information
Name
Narges Saber
Name of organization / entity
Gonabad Uneversity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 53 3822 7703
Email address
n.saber@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2014-05-22, 1393/03/01
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of rhythmic breathing on chest pain and cardiorespiratory parameters Acute Coronary Syndrome patients admitted at CCU
Public title
The effect of rhythmic breathing on Acute Coronary Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Volunteer for research; ACS definitive diagnosis by the cardiologist; Lack of critical state of health (no cardiac dysrhythmia, hemodynamic and peripheral capillary oxygen saturation less than 80%) licensed clinician; Non-smoking; Lack of alcoholism and drug; Lack of respiratory diseases, gastrointestinal, diabetes and mental recognized and diagnosed by a physician; Age between 15-85 years
Exclusion criteria: Lack of satisfaction for cooperation; Create a life-threatening situation; The creation of any intervening circumstances that made it impossible to continue
Age
From 8 years old to 92 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
112
Randomization (investigator's opinion)
Randomized
Randomization description
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
Gonabad University of Medical Sciences
Street address
Gonabad University of Medical Sciences, Asian road, Gonabad, Khorasan Razavi, Iran
City
Gonabad
Postal code
Approval date
2014-05-22, 1393/03/01
Ethics committee reference number
gmu.rec.1393.5
Health conditions studied
1
Description of health condition studied
Acute Coronary Syndrome
ICD-10 code
I20.0
ICD-10 code description
Unstable angina
2
Description of health condition studied
Acute Coronary Syndrome
ICD-10 code
I21.0
ICD-10 code description
Acute transmural myocardial infarction of anterior wall
3
Description of health condition studied
Acute Coronary Syndrome
ICD-10 code
I21.1
ICD-10 code description
Acute transmural myocardial infarction of inferior wall
4
Description of health condition studied
Acute Coronary Syndrome
ICD-10 code
I21.2
ICD-10 code description
Acute transmural myocardial infarction of other sites
5
Description of health condition studied
Acute Coronary Syndrome
ICD-10 code
I21.3
ICD-10 code description
Acute transmural myocardial infarction of unspecified site
6
Description of health condition studied
Acute Coronary Syndrome
ICD-10 code
I21.4
ICD-10 code description
Acute subendocardial myocardial infarction
7
Description of health condition studied
Acute Coronary Syndrome
ICD-10 code
I21.9
ICD-10 code description
Acute myocardial infarction, unspecified
Primary outcomes
1
Description
Chest pain
Timepoint
Before and during 12 hours after intervention.
Method of measurement
McGill pain scale
2
Description
Systolic and diastolic blood pressure
Timepoint
Before and during 12 hours after intervention.
Method of measurement
Monitoring
3
Description
Respiratory rate
Timepoint
Before and during 12 hours after intervention.
Method of measurement
Monitoring
4
Description
Respiratory rythme
Timepoint
Before and during 12 hours after intervention.
Method of measurement
Monitoring
5
Description
Pulse rate
Timepoint
Before and during 12 hours after intervention.
Method of measurement
Monitoring
6
Description
Pulse rythme
Timepoint
Before and during 12 hours after intervention.
Method of measurement
Electrocardiogram
7
Description
peripheral capillary oxygen saturation
Timepoint
Before and during 12 hours after intervention.
Method of measurement
Pulse oxymeter
8
Description
The need for drug
Timepoint
Before and during 12 hours after intervention.
Method of measurement
Patient pan card
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group will do the rhythmic breathing for twenty minutes every five minutes once and it will take a minute and during their breathing will focus only on entering and leaving air. In this way that the patient will be supine state with eyes closed and with counting numbers 1, 2 and 3 will enter air through the nose into the lungs, then by counting 1, 2 and 3 will keep the air in their lungs and finally, by counting 1, 2 and 3 will out the air through the mouth.
Category
Other
2
Description
In control group, the intervention will not take place except routine treatments.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Doctor Chamran Hospital of Tehran
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Investigator
Full name of responsible person
Narges Saber
Street address
Gonabad University of Medical Sciences, Asian road, Gonabad, Khorasan Razavi, Iran
City
Gonabad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Investigator
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Narges Saber
Position
Msc student in intensive care nursing
Other areas of specialty/work
Street address
Gonabad University of Medical Sciences, Asian road, Gonabad, Khorasan Razavi, Iran
City
Gonabad
Postal code
Phone
+98 51 5722 3514
Fax
Email
n.saber@gmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Narges Saber
Position
Bachelor of Science Degree in Nursing, Msc student in intensive care nursing
Other areas of specialty/work
Street address
Gonabad University of Medical Sciences, Asian road, Gonabad, Khorasan Razavi, Iran
City
Gonabad
Postal code
Phone
+98 51 5722 3514
Fax
Email
n.saber@gmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Narges Saber
Position
Bachelor of Science Degree in Nursing, Msc student in intensive care nursing
Other areas of specialty/work
Street address
Gonabad University of Medical Sciences, Asian road, Gonabad, Khorasan Razavi, Iran
City
Gonabad
Postal code
Phone
+98 51 5722 3514
Fax
Email
n.saber@gmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)