Effect of breathing exercises on pain in patients with limb fractures
Design
Clinical trial with a control group, with parallel groups, Single blinded, randomized on 100 patients. Sealed Envelope software will be used for randomization.
Settings and conduct
This study will be conducted in the educational center of Valiasr hospital in Arak city. In this intervention, the correct way of diaphragmatic breathing will be explained in a practical way And to measure the pain level of the patients before and after the intervention, a visual pain intensity scale will be used (Visual scale of pain is a 10 cm line, with a score of ten for the most severe pain and a score of zero for no pain). Only the analyzers do not know how the samples are placed in the groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: The patient should be conscious, The patient has a broken limb, The patient is hospitalized, The patient should be 18-50 years old, The patient does not have a history of drug abuse؛ Exclusion criteria: The patient has an underlying disease, Patient non-cooperation
Intervention groups
Intervention group: In this group, a 10 cm line is used for the visual scale of pain intensity, where a score of ten is the most severe pain and a score of zero is no pain. Training of diaphragmatic breathing technique in the intervention group is done face to face by the researcher on the day before surgery. Training continues as long as learning occurs, Then the patients are requested to perform the given training 5 times a day and each time for 10 minutes and after that, complete the visual pain measurement scale. Control group: During this period, they do not receive this intervention and only fill out the questionnaire, and their pain intensity is initially measured by the mentioned method.
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210501051142N6
Registration date:2022-11-22, 1401/09/01
Registration timing:prospective
Last update:2022-11-22, 1401/09/01
Update count:0
Registration date
2022-11-22, 1401/09/01
Registrant information
Name
Aida Arjloo
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3402 0115
Email address
golmehrsherafati@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-22, 1401/10/01
Expected recruitment end date
2023-01-21, 1401/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of breathing exercises on pain in patients with limb fractures
Public title
Effect of breathing exercises on pain in patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The patient should be conscious.
The patient has a broken limb.
The patient is hospitalized.
The patient must be 18-50 years old.
The patient does not have a history of drug abuse.
The patient should be literate.
The patient is already trained.
Exclusion criteria:
The patient has a history of mental disorder, hearing disorder, and mental retardation.
The patient has injuries to the face and thorax.
The patient has an addiction.
The patient has a history of fibromyalgia, arthritis and rheumatism.
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are assigned to groups in the order of arrival and based on the randomization sequence that will be generated in advance. This sequence is unpredictable and does not have a specific pattern, and its arrangement is completely random. To assign the samples to two groups, the block randomization method will be used with a block size of 4, so that by using the random number generation software in the block method, the randomization sequence will be produced according to the required sample size for the two groups. First, all the states where two letters A and B can be arranged together in a block of 2 are created, and a block is randomly selected by placing it between the blocks, and from the arrangement pattern in that block for patient allocation is used then this block will be placed in the main container and another block will be selected again. All this will be done with software called Sealed Envelope. With this method, concealment will also be observed. The concept of concealment is to unpredictably assign individuals to groups that the researcher will not be able to predict which group the next person will be in.
Blinding (investigator's opinion)
Single blinded
Blinding description
The data analyzer will not know how the samples are placed in the intervention and control groups. Other people in the study will be aware of this placement.
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
Arak university of medical sciences, Basij Sq., Sardasht region
City
Arak
Province
Markazi
Postal code
3848176593
Approval date
2022-07-03, 1401/04/12
Ethics committee reference number
IR.ARAKMU.REC.1401.110
Health conditions studied
1
Description of health condition studied
The amount of pain
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The amount of pain
Timepoint
three days and twice a day (one hour before the intervention and 4 hours after the intervention)
Method of measurement
At the beginning and end of the study, the visual pain scale of interventions is completed by the patients of both groups, and based on this, the pain level of the patients is determined.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, a 10 cm line is used for the visual scale of pain intensity, where a score of ten is the most severe pain and a score of zero is no pain. This visual pain measurement scale is completed by the patient twice a day for three days (one hour before the intervention and 4 hours after the intervention).Training of diaphragmatic breathing technique in the intervention group is done face to face by the researcher on the day before surgery (In such a way that participants are asked to lie on their back with pillows under their head and knees and place one hand on their chest and the other on their stomach. While inhaling, they will move the hand upwards on the abdomen and push the air into the lungs through the nose. While exhaling, they will move the hand down on the stomach and expel the air from the mouth. The other hand will remain motionless on the chest in both cases.), Training continues as long as learning occurs. Then the patients are requested to perform the given training 5 times a day and each time for 10 minutes. At the end, the patients are asked to complete the visual pain scale tool as requested by the researcher.
Category
Other
2
Description
Control group: During this period, they do not receive this intervention and only fill out the questionnaire, and their pain intensity is initially measured by the mentioned method.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Arak educational and therapeutic center
Full name of responsible person
Mehran Azami
Street address
Central Province, Arak, Imam Khomeini St., Valiasr Square
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3278 2021
Email
golmehrsherafati@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
DR Alireza Kamali
Street address
University complex of the Great prophet, Basij square, Sardasht
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3493 4634
Email
golmehrsherafati@gmail.com
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
80
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
Mehran Azami
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
University complex of the Great prophet, Basij square, Sardasht.
City
Arak
Province
Markazi
Postal code
3819693345
Phone
009886341735057
Email
golmehrsherafati@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mehran Azami
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Arak
City
University complex of the Great prophet, Basij square, Sardasht.
Province
Markazi
Postal code
3819693345
Phone
009886341735057
Email
golmehrsherafati@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mehran Azami
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
University complex of the Great prophet, Basij square, Sardasht.
City
Arak
Province
Markazi
Postal code
3819693345
Phone
009886341735057
Email
golmehrsherafati@gmail.com
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
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
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Only the part of the data related to the original outcome will be able to be shared.
When the data will become available and for how long
Since the spring of 2023
To whom data/document is available
Researchers and students in this field
Under which criteria data/document could be used
In order to reduce the pain of hospitalized patients
From where data/document is obtainable
Vice chancellor for education and research, Arak university of medical sciences
What processes are involved for a request to access data/document
These documents will be available on the website of Arak university of medical sciences.