Determining the effect of rhythmic breathing on severity of pain and anxiety in patients after coronary artery bypass graft surgery
Design
This research is a clinical trial with a sample size of 102 people. The method of assigning the intervention to the subjects was randomized and random blocked blocks with block size 4 (using a random permutation table). The intervention used in this research According to a randomized list, a person outside the study who is not aware of research objectives and who is assigned a different code for sealed envelopes and assigned to any disease that is included in the study. In this way, the samples will be divided into two groups of intervention and control.
Settings and conduct
Icu section of Ahvaz Oil Hospital
Participants/Inclusion and exclusion criteria
Not being in a critical health condition
Not having a history of taking sedative medicines and antidepressants
The absence of known and diagnosed psychiatric illnesses by the physician
Age of at least 30 and maximum 75 years
Intervention groups
The intervention group performs rhythmic respiration. The patient is asked to close his eyes, lie in the back position (soping), and count the numbers from 1 to 3 of the tail through the nose, then relieve the numbers from 1 to 3 breaths by counting them. Take 1 to 3 breaths through the mouth and focus only on entering and leaving the air during breathing.
The control group will not receive any intervention.
Main outcome variables
Pain intensity؛ anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181123041729N1
Registration date:2018-12-08, 1397/09/17
Registration timing:prospective
Last update:2018-12-08, 1397/09/17
Update count:0
Registration date
2018-12-08, 1397/09/17
Registrant information
Name
Samereh Nasirnezhad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3443 9964
Email address
nasirnejad.s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-11, 1397/09/20
Expected recruitment end date
2019-02-09, 1397/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of rhythmic breathing on pain intensity and anxiety in patients after coronary artery bypass graft surgery
Public title
The effect of rhythmic breathing on pain intensity and anxiety in patients after coronary artery bypass graft surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing coronary artery bypass graft surgery
Age of at least 30 and maximum 75 years
Not having a history of taking sedative medicines and antidepressants
The absence of known and diagnosed psychiatric illnesses by the physician
Exclusion criteria:
having a history of taking sedative medicines and antidepressants
The diagnosis of mental illness is documented
Age
From 30 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
102
Randomization (investigator's opinion)
Randomized
Randomization description
The method of assigning intervention to individuals was randomized and random blocked blocks with block size 4 (using the table for random permutations). The randomization list is provided by a statistic specialist. Blocking is usually used to create a balance in the number of specimens assigned to each of the studied groups. In this trial, there were two groups of 4 blocks consisting of 2 participants in the intervention group and 2 participants in the control group. The intervention used in this study according to a randomized list is provided by a person outside the study who is not aware of the research objectives and will be assigned a different code to the closed envelopes and will be allocated to any disease that is included in the study. In this way, a number of envelopes with an aluminum sleeve (for the lack of clarity of the contents of the envelopes) are prepared and each random sequence created on the card is recorded and the cards are inserted into the envelopes respectively. In order to maintain a random sequence, the numbering of envelopes on the outer surface is done in the same order. Finally, the door of the envelopes is pasted and placed in the box, respectively. At the time of the registration of the participants, one of the envelopes of the letter was opened in accordance with the order of the entry of the eligible participants, and the group allocated to it Participant will be revealed.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
Secondary trial Id
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz University of Medical Sciences
Street address
City university, Assistant Professor of Research and Technology Development, Ahvaz, Ground floor
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2018-11-03, 1397/08/12
Ethics committee reference number
IR.AJUMS.REC.1397.570
Health conditions studied
1
Description of health condition studied
Coronary artery Bypass Graft Patients
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease of native coronary artery
Primary outcomes
1
Description
Pain intensity
Timepoint
On the first day of operation (after extubation and alertness of the patient) and on the second and third days of operation, every time before and after the intervention
Method of measurement
Visual Analogue Scale
2
Description
Anxiety
Timepoint
Speilberger Anxiety scale
Method of measurement
The second day of surgery before and after the intervention
Secondary outcomes
1
Description
The amount of analgesic use
Timepoint
On the first, second and third days of action
Method of measurement
Through the checklist
Intervention groups
1
Description
Intervention group: In the ICU section, the patient is asked to measure rhythmic pain on the first day of operation (after extubation and alertness of the patient) and on the second and third days of the operation, which will allow rhythmic breathing for 20 minutes every 5 minutes once and every time It takes one minute to complete the training three times a day. Every day before and after the intervention, the pain assessment questionnaire will be completed by the researcher and interview method. To measure the amount of anxiety, the second day of the operation requires patients to take the intervention three times a day according to the procedure described above. Before and after the intervention, the Spielberger anxiety inventory will be completed by the researcher.
Category
Treatment - Other
2
Description
Control group: No intervention will be performed. During the first, second and third day, the intensity of pain will be measured and the second day of anxiety will be measured.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Heart Surgery ward and ICU Heart of Ahvaz Oil Hospital
Full name of responsible person
Samereh Nasirnezhad
Street address
Three way airport, large oil hospital
City
Ahvaz
Province
Khouzestan
Postal code
6164795573
Phone
+98 61 3443 9964
Fax
Email
nasirnejad.s@ajums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr Mohammad Badvi
Street address
University of Medical Sciences, Assistant Professor of Research and Technology, Jundishapur University of Medical Sciences and Health Services, Ahvaz, Ground floor
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3333 3477
Fax
Email
nasirnejad.s@gmail.com
Web page address
http://www.ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Samereh Nasirnezhad
Position
Nursing Graduate Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
University of Medical Sciences, Jundishapur University of Medical Sciences, Faculty of Nursing and Midwifery
City
Ahvaz
Province
Khouzestan
Postal code
6135715749
Phone
+98 613311159
Email
nasirnejad.s@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Samereh Nasirnezhad
Position
Nursing Graduate Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
University of Medical Sciences, Jundishapur University of Medical Sciences, Faculty of Nursing and Midwifery
City
Ahvaz
Province
Khouzestan
Postal code
6135715749
Phone
+98 613311159
Email
nasirnejad.s@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Samereh Nasirnezhad
Position
Nursing Graduate Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
University of Medical Sciences, Jundishapur University of Medical Sciences, Faculty of Nursing and Midwifery
City
Ahvaz
Province
Khouzestan
Postal code
6135715749
Phone
+98 613311159
Email
nasirnejad.s@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available