The effect of Benson relaxation technique on the severity of pain caused by spinal anesthesia after general and urological surgery in the candidates of elective and general surgeries
The aim of this study was to investigate the effect of Benson’s relaxation on the severity of pain caused by spinal anesthesia during surgery.
Design
In this study, 60 patients who are candidates for Urology and general surgery and will be anesthetized in the spinal method, will be randomly selected and assigned into two intervention and control groups. For randomization, the same cards which characterized by 1 and 2 will be used.
Settings and conduct
This study will be done in general surgery and Urology wards of Imam Reza hospital in Kermanshah. The intervention group will be trained using audio files and educational brochures before surgery. On the surgery day, after the start of pain in the anesthetized area, the pain level will be evaluated using the VAS questionnaire, and then Benson relaxation will be performed for 10-20 minutes, and the pain will be assessed again by the VAS questionnaire.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients at the age of 18-60 years old; Having reading and writing skills; existing pain in the anesthetized area; Written consent.
Exclusion criteria: Having mental or nervous disorders; Using sedative medications; Drug addiction; Mental and motor disorders.
Intervention groups
The intervention group will receive Benson relaxation for 10-20 minutes after the start of pain in the anesthetized area on the day of surgery.
Control group will not receive any intervention and they will receive routine treatment.
Main outcome variables
pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130603013568N6
Registration date:2018-06-22, 1397/04/01
Registration timing:registered_while_recruiting
Last update:2018-06-22, 1397/04/01
Update count:0
Registration date
2018-06-22, 1397/04/01
Registrant information
Name
Rostam Jalali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3724 6613
Email address
rjalali@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2018-08-23, 1397/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Benson relaxation technique on the severity of pain caused by spinal anesthesia after general and urological surgery in the candidates of elective and general surgeries
Public title
The effect of Benson's relaxation technique on spinal anesthesia pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients at the age of 18-60 years old
Having reading and writing skills
Pain in the anesthetized area
Written consent
Exclusion criteria:
Psychiatric and neurologic disorder
Use of sedative medications
Drug addiction
Mental and motor disorders
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done using random number table.
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 Kermanshah University of Medical Sciences
Street address
Shahid Beheshti Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2018-05-22, 1397/03/01
Ethics committee reference number
IR.KUMS.REC.1397.126
Health conditions studied
1
Description of health condition studied
Pain
ICD-10 code
G89.18
ICD-10 code description
Other acute postprocedural pain
Primary outcomes
1
Description
Pain
Timepoint
Before and after intervention
Method of measurement
Visual Analog Scale
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group, on the day of surgery after the patient arrives at the ward, the ending time of anesthetizing is evaluated by the investigator. This assessment involves checking the return of the sense of hands and feet using the needle and checking the abdominal and leg muscle tone. After the start of pain in anesthetized area, it is assessed using the pain intensity scale. After evaluation, the patient will benefit from the usual palliative care, at this time the relaxation method will be used in this way: The patient is asked to be in a comfortable position, Closing his eyes slowly and relaxing all the muscles deeply beginning from the legs and go ahead on the face and keeps this relaxed state. At the same time the patient should breath via nose and should be aware of or pay attention to his/her breathing. After that he/she should breath out via mouth whispering the word "one" and breathing as usual. This process will be repeated every 10 to 20 minutes based on patient tolerance.
Category
Treatment - Other
2
Description
The control group will not receive any intervention but will receive the routine treatment.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Zahra Keihani
Street address
No.10, Mahdieh َAve
City
Ghorveh
Province
Kurdistan
Postal code
6661847499
Phone
+98 87 3522 4171
Email
ZPK60@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafi
Street address
Vice chancellor for Research and Technology, No 2 Building, Shahid Beheshti Blvd.
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3835 8259
Email
daftarriasat@Kums.ac.ir
Web page address
http://www.Kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Rostam Jalali
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing Department ,Faculty of Nursing and Midwifery, Dolat Abad Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6719851351
Phone
+98 83 3724 6613
Fax
+98 83 3826 3048
Email
ks_jalali@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Rostam Jalali
Position
َAssociate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing Department, Faculty of Nursing and Midwifery, Dolat Abad Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6719851351
Phone
+98 83 3724 6613
Fax
+98 83 3826 3048
Email
ks_jalali@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Rostam Jalali
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing Department, Faculty of Nursing and Midwifery, Dolat Abad Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6719851351
Phone
+98 83 3724 6613
Fax
+98 83 3826 3048
Email
ks_jalali@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