The effect of diaphragmatic breathing on chest pain, anxiety and physiologic parameters in patients with acute coronary syndrome in the emergency department
Effect of diaphragmatic breathing on chest pain, anxiety and physiologic parameters in patients with acute coronary syndrome in the emergency department
Design
A clinical trial with a parallel group, with randomized block design, With a sample size of 60 patients
Settings and conduct
To perform the study, research samples were assigned to the following groups randomly:
The first group: performing of diaphragmatic breathing for 10 minutes.
The second group: routine actions.
The intensity of chest pain, anxiety and the vital signs of systolic pressure, diastolic pressure, pulse, and oxygen saturation will be measured in before and after the intervention/routine actions in the two groups.
Participants/Inclusion and exclusion criteria
Ability to communicate; Addiction; Diabetes diseaes
Intervention groups
Intervention group: Perform diaphragmatic breathing for 10 minutes, first raising the patient's head up to 30 degrees, and asking the patient to place his hands preferably on the abdomen and then first take a gentle breath from the nose. The patient is requested to focus on the abdomen while breathing deeply, and to pay attention to the extent of the abdomen to a maximum extent so that its elevation can be seen or felt by the hands it is placed on the abdomen. Then, after a full tail, the exertion is slowly performed.
Control group: Routine action is done.
Main outcome variables
Chest pain severity; anxiety; vital signs
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20101108005134N12
Registration date:2019-01-09, 1397/10/19
Registration timing:registered_while_recruiting
Last update:2019-01-09, 1397/10/19
Update count:0
Registration date
2019-01-09, 1397/10/19
Registrant information
Name
Ali Fakhr-Movahedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4192
Email address
Alimovi49@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2020-03-21, 1399/01/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of diaphragmatic breathing on chest pain, anxiety and physiologic parameters in patients with acute coronary syndrome in the emergency department
Public title
Effect of diaphragmatic breathing pain severity, anxiety and physiologic parameters
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Ability to communicate
The first time of getting acute coronary syndrome
Normal respiration pattern in patient
Exclusion criteria:
Addiction
Diabetes disease
Injury to chest and abdomen
Occurring crisis condition
Alteration in patient status
Age
From 40 years old to 80 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 research sample assigned to the groups of the study by permuted blocks randomization. Also, blocking be used within gender and age strata.
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 Semnan University of Medical Sciences
Street address
Research and technology deputy, Semnan University of Medical Sciences, Basij Blvd
City
Semnan
Province
Semnan
Postal code
35198-99951
Approval date
2018-11-20, 1397/08/29
Ethics committee reference number
IR.SEMUMS.REC.1397.194
Health conditions studied
1
Description of health condition studied
Acute ischemic heart disease
ICD-10 code
I24.9
ICD-10 code description
Acute ischemic heart disease, unspecified
Primary outcomes
1
Description
Chest pain severity
Timepoint
Before and immediately after intervention
Method of measurement
The pain numerical rating scale
2
Description
Anxiety
Timepoint
Before and after intervention
Method of measurement
7 item anxiety Spielberger scale
3
Description
Blood pressure
Timepoint
Before and after intervention
Method of measurement
Aneroid sphygmomanometer
4
Description
Pulse
Timepoint
Before and after intervention
Method of measurement
Pulse oximeter
5
Description
O2 saturation
Timepoint
Before and after intervention
Method of measurement
Pulse oximeter
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Perform diaphragmatic breathing for 10 minutes, first raising the patient's head up to 30 degrees, and asking the patient to place his hands preferably on the abdomen and then first take a gentle breath from the nose. The patient is requested to focus on the abdomen while breathing deeply, and to pay attention to the extent of the abdomen to a maximum extent so that its elevation can be seen or felt by the hands it is placed on the abdomen. Then, after a full tail, the exertion is slowly performed.
Category
Treatment - Other
2
Description
Control group: Routine action is done.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Army hospital 502
Full name of responsible person
Dr. Masoud Memarian
Street address
Corner of Bahar St., Taleghani Ave.
City
Tehran
Province
Tehran
Postal code
15717
Phone
+98 21 8882 8001
Email
info@502hospital.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Parviz Kokhaei
Street address
Research and technology deputy, Semnan University of Medical Sciences, Basij Blvd. بلوار بسیج؛ دانشگاه علوم پزشکی سمنان؛ معاونت تحقیقات و فناوری
City
Semnan
Province
Semnan
Postal code
35198-99951
Phone
+98 23 3344 1022
Email
p_kokha@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Dr. Ali Fakhr-Movahedi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing School, Semnan University of Medical Sciences, 5th km Damghan road
City
Semnan
Province
Semnan
Postal code
35198-99951
Phone
+98 23 3365 4192
Email
Alimovi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Ali Fakhr-Movahedi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing School, Semnan University of Medical Sciences, 5th km Damghan road
City
Semnan
Province
Semnan
Postal code
35198-99951
Phone
+98 23 3365 4192
Email
Alimovi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Ali Fakhr-Movahedi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing School, Semnan University of Medical Sciences, 5th km Damghan road
City
Semnan
Province
Semnan
Postal code
35198-99951
Phone
+98 23 3365 4192
Email
Alimovi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
1. The study protocol 2. The results of the study
When the data will become available and for how long
After termination of the study
To whom data/document is available
1. Faculty members 2. The clinical nurses 3. The medical and nursing students
Under which criteria data/document could be used
Access to data or documentation is subject to the following conditions: 1- Use in Future Studies References 2- The future studies
From where data/document is obtainable
Please contact Ali Fakhr-Movahedi Email: alimovi@yahoo.com
What processes are involved for a request to access data/document
After emailing Ali Fakhrmohahdi, email will be answered as soon as possible.