Comparison of the effect of diaphragmatic breathing and pursed lip breathing on pain control and sleep quality in patients with laparotomy
Design
This study is a randomized clinical trial with a parallel design and a control group. This randomized, non-blinded study will be conducted on 75 eligible patients. A table of random numbers is used for randomization and the participants are assigned to two intervention groups and one control group.
Settings and conduct
This study, which will be conducted in Amin Shahr Hospital in Isfahan, is not blinded. Respiratory intervention training will be given face to-face on the day of the operation, after surgery, with comprehensible sentences.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Informed consent; Age between 20 and 60 years; Patients undergoing laparotomy surgery; Ability to speak and understand Persian language
Exclusion criteria:History of lung diseases; History of smoking, benzodiazepine and alcohol consumption; Chronic exposure to environmental and chemical stimuli; History of previous laparotomy
Intervention groups
The first intervention group performed the diaphragmatic breathing technique in a semi-sitting position (while lying on the back in the bed with the shoulders supported by a pillow) at least 10 times per day (on the day of surgery, after surgery, and days after surgery).The second intervention group will perform the bud lip breathing technique (exhalation time should be twice the inhalation time) at least 10 times every day (on the day of surgery, after surgery and days after surgery). The control group will receive routine care and no new intervention will be performed.
Main outcome variables
intensity of pain, sleep quality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N213
Registration date:2024-03-06, 1402/12/16
Registration timing:prospective
Last update:2024-03-06, 1402/12/16
Update count:0
Registration date
2024-03-06, 1402/12/16
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-29, 1403/01/10
Expected recruitment end date
2024-06-30, 1403/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of diaphragmatic breathing and pursed lip breathing on pain control and sleep quality in patients with laparotomy
Public title
Comparison of the effect of diaphragmatic breathing and pursed lip breathing on pain control and sleep quality in patients with laparotomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent
Age between 20 and 60 years
Patients undergoing laparotomy surgery
Ability to speak and understand Persian language
Fully alert and aware of time and place
Exclusion criteria:
History of lung diseases
History of smoking, benzodiazepine and alcohol consumption
Chronic exposure to environmental and chemical stimuli
History of previous laparotomy
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Generate random numbers using online software. Divided quadrants will be drawn on 24 sheets of paper (in the number of patients) and random numbers will be written on each quadrant. Then, each of the papers will be placed in an envelope. Each patient removes an envelope and based on that, the method of placement of elastic seperator will be done in each quadrant. The production of random numbers and allocation concealment will be done by an impartial observer.
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 Islamic Azad University, Khorasgan branch
Street address
Vice Chancellor for Research Affairs, University Blvd., Arghwanieh, J Sharghi Street
City
Isfahan
Province
Isfehan
Postal code
8155139998
Approval date
2023-04-18, 1402/01/29
Ethics committee reference number
IR.IAU.KHUISF.REC.1402.019
Health conditions studied
1
Description of health condition studied
Laparotomy
ICD-10 code
Z53.31
ICD-10 code description
Laparoscopic surgical procedure converted to open procedure
Primary outcomes
1
Description
intensity of pain
Timepoint
24, 48 and 72 hours after laparotomy
Method of measurement
The visual analog scale (VAS)
2
Description
sleep quality
Timepoint
24, 48 and 72 hours after laparotomy
Method of measurement
Using hospital sleep quality questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group performed the diaphragmatic breathing technique in a semi-sitting position (while lying on the back in the bed with the shoulders supported by a pillow) at least 10 times per day (on the day of surgery, after surgery, and days after surgery).
Category
Treatment - Other
2
Description
The second intervention group will perform the bud lip breathing technique (exhalation time should be twice the inhalation time) at least 10 times every day (on the day of surgery, after surgery and days after surgery).
Category
Treatment - Other
3
Description
The control group will receive routine care and no new intervention will be performed.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Amin Hospital
Full name of responsible person
Yeganeh Dehghani Najvani
Street address
Amin Hospital, Ebnesina Street
City
Isfahan
Province
Isfehan
Postal code
5314181486
Phone
+98 31 3445 5051
Email
yeganehdehghani@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Majid Meshkini
Street address
Vice Chancellor for Research Affairs, University Blvd., Arghwanieh, J Sharghi Street
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
meshkini@miums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Yeganeh Dehghani Najvani
Position
Nursing master's student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, University Blvd., Arghwanieh, J Sharghi Street
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
yeganehdehghani@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University, Isfahan branch
Full name of responsible person
Dr. Marziyeh Ziaeirad
Position
Member of the academic staff of Islamic Azad University
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, University Blvd., Arghwanieh, J Sharghi Street
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
m.ziaeirad@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Yeganeh Dehghani Najvani
Position
Nursing master's student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, University Blvd., Arghwanieh, J Sharghi Street
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
yeganehdehghani@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