Comparison of the effect of rhythmic breathing and progressive muscle relaxation on surgical site pain in patients who are candidates for abdominal hernia surgery
Comparison of the effect of rhythmic breathing and progressive muscle relaxation on surgical site pain in patients who are candidates for abdominal hernia surgery
Design
A clinical trial on 120 patients candidates for abdominal hernia surgery with a control group, one blind and randomized in a block method with a volume of 6
Settings and conduct
This study is conducted on candidates for abdominal hernia in Imam Hossein (AS) Shahroud Hospital. Relaxation and rhythmic breathing techniques are performed in 4 stages after surgery (3, 6, 12, 24 hours after consciousness). The intensity of pain 20 minutes before and after each intervention period is assessed using VAS.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
According to the American Society of Anesthesiology (ASA) classification, the patient is in class 1 or 2;
Ability to read and write Farsi;
Age range from 18 to 75 years.
Exclusion criteria:
Addiction to drugs and painkillers; Having any psychomotor and cognitive disorder;
Having a history of taking sedatives, and painkillers for more than one month, according to the patient's self-report.
Intervention groups
The samples include three groups A progressive muscle relaxation and group B rhythmic breathing and group C control group. The control group will consist of patients who will only receive routine care. The relaxation group relaxes and contracts the muscles according to certain principles for 20 minutes in each session, and in the rhythmic breathing method, patients are asked to close their eyes while lying on their backs, inhale through the nose, and exhale through the mouth. and do this for 20 minutes in each session
Main outcome variables
Postoperative pain score of patients based on VAS scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200206046395N2
Registration date:2023-01-31, 1401/11/11
Registration timing:prospective
Last update:2023-01-31, 1401/11/11
Update count:0
Registration date
2023-01-31, 1401/11/11
Registrant information
Name
Mobin Mottahedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3233 8090
Email address
mobinmottahedi1372@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-09, 1401/11/20
Expected recruitment end date
2023-08-11, 1402/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of rhythmic breathing and progressive muscle relaxation on surgical site pain in patients who are candidates for abdominal hernia surgery
Public title
Comparison of the effect of rhythmic breathing and progressive muscle relaxation on surgical site pain in patients who are candidates for abdominal hernia surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
According to the American Society of Anesthesiology (ASA) classification, the patient is in grade 1 or 2
Ability to read and write persian
Age range from 18 to 75 years
Exclusion criteria:
Addiction to drugs and painkillers
Having any psychomotor and cognitive disorders
Having a history of taking sedatives, painkillers for a period of more than one month according to the patient's self-report
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
In the beginning, all the modes in which 3 letters A, B and C can be put together in a block of 6 are produced and a block is selected randomly and by placing among the blocks.The layout pattern in that block is used to allocate patients
Blinding (investigator's opinion)
Single blinded
Blinding description
Due to the nature of the study, it is not possible to blind the study participants. However, measures were taken in collecting information. After the intervention, the person collecting the information will not know the type of the participants' group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahrood University of Medical Sciences
Street address
Haft Tir Square, Shahrood University of Medical Sciences
City
Shahrood
Province
Semnan
Postal code
3616718473
Approval date
2022-11-02, 1401/08/11
Ethics committee reference number
IR.SHMU.REC.1401.186
Health conditions studied
1
Description of health condition studied
Hernia
ICD-10 code
K40
ICD-10 code description
Inguinal hernia
Primary outcomes
1
Description
Postoperative pain score in VAS
Timepoint
3, 6, 12, 24 hours after consciousness after surgery
Method of measurement
VAS visual analog scale
Secondary outcomes
1
Description
Taking painkillers
Timepoint
At 3, 6, 12 and 24 hours after consciousness after surgery.
Method of measurement
check list
Intervention groups
1
Description
Intervention group: Intervention group: Patients in the progressive muscle relaxation intervention group learn how to perform the progressive muscle relaxation technique the day before surgery by using an educational pamphlet and providing oral training by the researcher. The training is provided by the researcher in clear and fluent sentences and. Patients are taught how to relax and contract their 16 main muscle groups according to certain principles, including the muscles of the face, hands, shoulders, legs, back, etc., keeping the muscles contracted for 3 to 5 seconds in all stages. And 10 to 15 seconds are dedicated to rest
Category
Rehabilitation
2
Description
Intervention group: Patients in the rhythmic breathing group learn how to perform the rhythmic breathing technique the day before the operation by using an educational pamphlet and providing oral training by the researcher. This training is provided by the researcher using simple and understandable sentences. The technique is such that the patients are asked to close their eyes while lying on their back, inhale through the nose, then hold their breath and exhale through the mouth, and each time from number 1 to Count 3. All patients in the intervention group are instructed to focus only on inhaling and exhaling air during breathing and are asked to perform rhythmic breathing every five minutes for one minute each time for a period of 20 minutes (a total of four times every 20 minutes).
Category
Rehabilitation
3
Description
Control group: In the control group, no intervention will be done and they will only receive drugs and routine ward care, and only the pain intensity of the patients will be measured and recorded in the above steps.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein (AS) Hospital
Full name of responsible person
Mobin Mottahedi
Street address
Haft Tir Square, Shahrood University of Medical Sciences
City
Shahrood
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Phone
+98 23 3233 8090
Email
mobinmottahedi1372@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mohammadhasan Imamian
Street address
Haft Tir Square, Shahrood University of Medical Sciences
City
Shahrood
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Phone
+98 23 3239 5054
Email
pishgiri@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shahrood 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
Shahroud University of Medical Sciences
Full name of responsible person
Mobin Mottahedi
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Kargar Square - Nawab - Second Thought - No. 21
City
Shahrood
Province
Semnan
Postal code
3618675313
Phone
+98 23 3233 8090
Email
mobinmottahedi1372@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mobin Mottahedi
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Kargar Square - Nawab - Second Thought - No. 21
City
Shahrood
Province
Semnan
Postal code
3618675313
Phone
+98 23 3233 8090
Email
mobinmottahedi1372@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mobin Mottahedi
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Kargar Square - Nawab - Second Thought - No. 21
City
Shahrood
Province
Semnan
Postal code
3618675313
Phone
+98 23 3233 8090
Email
mobinmottahedi1372@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
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Only part of the data, such as information related to the main outcome, can be shared.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Only for researchers working in academic and scientific institutions
Under which criteria data/document could be used
If necessary, by contacting Mobin Mottahedi and if there is a logical justification for using it for scientific purposes
From where data/document is obtainable
Mobin Mottahedi, Shahrood, Haft Tir Square, Shahrood University of Medical Sciences; Faculty of paramedicine
What processes are involved for a request to access data/document
During a phone call or via e-mail and registering the request and stating the reason and purpose, which is logical and approved, up to two weeks