Investigating the effect of Benson's relaxation method training on intensity of pain and the amount of painkillers consumed in patients who are candidates for leg amputation
Determining the effect of Benson relaxation training on the intensity of pain and the amount of painkillers consumed in patients who are candidates for leg amputation
Design
A clinical trial with a control group, not blind, randomized, on 40 patients. A table of random numbers was used for randomization.
Settings and conduct
the researcher will complete the VAS questionnaire for the two groups to check the pain intensity 6, 12, 24 and 48 hours after the surgery and compare the pain intensity between the two groups. The intervention in the intervention and control group will be recorded through the file and prescription sheet at 6-hour intervals, and they will be compared at 6, 12, 24, and 48 hours after the operation.The research environment is the inpatient ward of Kashani Hospital and the reception area of the operating room.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Lack of previous experience in teaching and practicing the Benson relaxation method by patients.
Non-entry criteria: Body mass index above and equal to 30.
Intervention groups
In the test group, the Benson relaxation method will be performed and no intervention will be performed for the control group (only the surgeon's routine is performed after the surgery). (The surgeon's routine refers to the common painkillers that the surgeon uses after the operation).The intervention will be conducted in 16 sessions and 15 sessions in the ward within 3 days before entering the operating room and one session at the operating room admission by the researcher and the patient will be asked after the operation to perform this technique
Main outcome variables
Change in the amount of pain (measured by VAS criteria) and the amount of painkillers consumed by patients (measured in 6 hours)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240727062551N1
Registration date:2024-08-16, 1403/05/26
Registration timing:registered_while_recruiting
Last update:2024-08-16, 1403/05/26
Update count:0
Registration date
2024-08-16, 1403/05/26
Registrant information
Name
Alireza Majidi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3777 2822
Email address
alireza1379fd@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-22, 1403/05/01
Expected recruitment end date
2025-02-19, 1403/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of Benson's relaxation method training on intensity of pain and the amount of painkillers consumed in patients who are candidates for leg amputation
Public title
Investigating Benson's relaxation on pain and the amount of painkillers used by patients who are candidates for leg amputation
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 65 years
Vigilance and trainability
Lack of previous experience in teaching and practicing the Benson relaxation method by patients
The patient does not suffer from cognitive disorders such as Alzheimer's
If the patient has psychiatric disorders, these disorders should not be in acute phase
Not using muscle relaxants and sleeping pills
No drug addiction
Absence of hearing and vision defects and movement disorders and nerve and muscle health according to self-report
Exclusion criteria:
Reluctance to participate in the study
The patient has liver and kidney failure
Body mass index above and equal to 30
Inability to learn or perform relaxation techniques correctly
Lack of awareness of time and place
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Allocation of samples in the test and control group will be done using envelopes that are prepared in advance using a table of random numbers. In this way, the researcher first determines by using the table of random numbers that all the people who are given an odd number will be in the intervention group and those who are given an even number will be in the control group. Then he closes his eyes and places his finger on one of the digits of the table of random numbers, while the direction of movement is predetermined by moving in the table of random numbers, he chooses the required number of even and odd numbers and all the numbers are placed in separate envelopes. All will be put in one box. When the sample enters the study with easy entry conditions, then card number one will be opened for him and depending on whether this card has an even or odd number, he will be placed in one of the two test or control groups.
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
Ethical Committee of Isfahan University of Medical Sciences
Street address
Research and Technology Vice-Chancellor, Building No. 4,Isfahan University of Medical Sciences and Health Care Services, Hazar Jarib St., Isfehan
City
Isfehan
Province
Isfehan
Postal code
8174673461
Approval date
2024-06-26, 1403/04/06
Ethics committee reference number
IR.MUI.MED.REC.1403.119
Health conditions studied
1
Description of health condition studied
Diabetic patients undergoing leg amputation surgery
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Pain score in visual analog scale questionnaire
Timepoint
Pain measurement at the beginning of the study (before starting to take painkillers) and 6, 12, 24 and 48 hours after the patient is fully awake.
Method of measurement
Visual analog scale
2
Description
Rate of using painkillers
Timepoint
Measurement of painkiller consumption 6, 12, 24 and 48 hours after the patient is fully awake
Method of measurement
The amount of painkillers consumed by the patients, which will be recorded through the file and prescription sheet at 6-hour intervals
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Diabetic patients undergoing foot amputation surgery, in addition to receiving the surgeon's routine after the operation, a sedation method is also used for them. In the intervention group, the researcher will teach Benson's relaxation technique by means of role-playing, educational video and presentation of pamphlets and audio files. gave The necessary training to perform this technique will be using simple and understandable sentences. In order to ensure learning this method, the client will be asked to perform this technique once in the presence of the researcher, and if there is any ambiguity, the researcher will clear it. In this way, the patient will perform this technique 15 times in these 3 days. He also conducts a session before entering the operating room in the admission area of the operating room by creating a private and quiet environment. The patient is also asked to use this technique for 48 hours after the operation. It is possible to write down the number of times and the time of doing it in the relevant form. In order to perform the correct Benson relaxation technique, this technique will be performed with the following sequence. First, the patient will be asked to lie down in a comfortable and quiet place and close his eyes. close yourself, then slowly relax your muscles from the bottom of the body to the top (first the leg muscles are relaxed and then this relaxation will continue to the face) and at the same time slowly begin to breathe deeply (in such a way that the tail through nose and exhalation will take place through the mouth.) The patient will be asked to focus more on his breathing while exhaling to think of positive events and repeat the word that makes him feel good. The person will continue this position for five minutes and during this time all the muscles of the body will be resting. Then the patient will be asked to open his eyes slowly, so that the body remains motionless for a few minutes. It is important to mention that you should not worry about whether the sedation will be deep or not. Rather, relaxation should be allowed to happen spontaneously, and if some negative thoughts cause the loss of concentration for relaxation, people will be asked to ignore these thoughts.
Category
Other
2
Description
Control group: Diabetic patients undergoing leg amputation surgery for whom the surgeon's routine is used after the operation and no relaxation techniques are performed for them (the surgeon's routine after the operation means the type of painkiller used by the surgeon, which is usually pethidine 50 mg/ml) Is )
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani hospital, Isfehan
Full name of responsible person
Alireza Majidi
Street address
Ayatollah Kashani Educational and Therapeutic Center, Ayatollah Kashani Street, Isfahan
City
Isfehan
Province
Isfehan
Postal code
8183983434
Phone
+98 31 3233 0091
Email
alireza379fd@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Asgari
Street address
Research and Technology Vice-Chancellor, Building No. 4, Isfahan University of Medical Sciences and Health Care Services, Hazar Jarib St., Isfehan
City
Isfehan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
askari@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
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
Alireza Majidi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Isfahan University of Medical Sciences and Health Services, Hazar Jarib St., Isfehan
City
Isfehan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
alireza1379fd@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Alireza Majidi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Isfahan University of Medical Sciences and Health Services, Hazar Jarib St., Isfehan
City
Isfehan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
alireza1379fd@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Alireza Majidi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Isfahan University of Medical Sciences and Health Services, Hazar Jarib St., Isfehan
City
Isfehan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Fax
Email
alireza1379fd@gmail.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
Due to ethical issues, patients' information is not disclosed to others
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available