Determining the effect of Benson and Jacobsen relaxation techniques on the anxiety level of inguinal hernia patients under spinal anesthesia in the operating room of Hakim Neishabour Hospital.
Design
This interventional study has a control group, with parallel groups in a double-blind randomized manner.
Settings and conduct
The place of study is the operating room of Hakim Neishabur Hospital.
Measuring anxiety in people using the Spielberger State Anxiety Questionnaire will be done in two time periods before the intervention and after the intervention (immediately before the spinal technique). Also, the patients' vital signs will be measured in these two intervals.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
• A person's ability to communicate
• Not suffering from psychological disorders
• No history of taking anti-anxiety drugs
• Elective and non-emergency inguinal hernia surgery
• No history of drug use
• Age over 18 years
• Performing spinal anesthesia for the first time
Exclusion criteria:
• Unwillingness to continue cooperation in the study
• Aggravation of the patient's physical condition
• History of spinal anesthesia
Intervention groups
ترجمه بیش از حد طولانی است و ذخیره نمیشود
The way of doing work in Jacobsen's intervention group is as follows:
This will be done 30 minutes before anesthesia.
In the Benson relaxation group, the following steps will be performed:
This will be done 30 minutes before spinal anesthesia.
For the control group, sedation interventions will not be performed and only the usual nursing training will be provided to them like the intervention group. Of course, at the end of the study, the study results and educational pamphlets will be provided to this group as well.
The effect of Benson and Jacobsen relaxation techniques on anxiety in inguinal hernia patients under spinal anesthesia
Public title
The effect of Benson and Jacobsen relaxation techniques on anxiety in inguinal hernia patients under spinal anesthesia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
• A person's ability to communicate
• Not suffering from psychological disorders
• No history of taking anti-anxiety drugs
• Elective and non-emergency inguinal hernia surgery
• No history of drug use
• Age over 18 years
• Performing spinal anesthesia for the first time
Exclusion criteria:
Unwillingness to continue cooperation in the study
Aggravation of the patient's physical condition
Reluctance to use spinal anesthesia
Failure to perform spinal
Intraoperative change from spinal to general anesthesia
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
The samples of this research will be selected in an accessible and purpose-based manner at first, and then a random allocation list will be generated using the block randomization method with blocks of 3, by the Random Allocation software, based on which these 105 people will be randomly selected. Benson relaxation technique, Jacobsen relaxation technique and control group (35 people in each group) will be placed in 3 groups. The order of assigning people to groups will be based on the list.
Blinding (investigator's opinion)
Double blinded
Blinding description
The random assignment of people in groups will be done by someone who does not know about the division of people into groups.
Also, patients are unaware of the existence of other study groups.
The statistical analyst will also be unaware of the allocation of people in groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Neyshabur University of Medical Sciences
Street address
Neyshabur University of Medical Sciences
City
Neyshabur
Province
Razavi Khorasan
Postal code
9319774448
Approval date
2023-07-04, 1402/04/13
Ethics committee reference number
IR.NUMS.REC.1402.007
Health conditions studied
1
Description of health condition studied
anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition
2
Description of health condition studied
Inguinal hernia
ICD-10 code
K40
ICD-10 code description
Inguinal hernia
Primary outcomes
1
Description
anxiety
Timepoint
Measuring anxiety in people using the Spielberger State Anxiety Questionnaire will be done in two time periods before the intervention and after the intervention (immediately before the spinal technique). Also, the patients' vital signs will be measured in these two intervals.
Method of measurement
Spielberger anxiety questionnaire and tools for measuring vital signs including a calibrated monitoring system in the operating room
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: jacobsen relaxation technique
Category
N/A
2
Description
Intervention group: benson relaxation technique
Category
N/A
3
Description
Control group: Without the intervention of relaxation techniques
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Neishabur Hakim Hospital
Full name of responsible person
Mehrdad Rohaninasab
Street address
Neishabur Hakim Hospital
City
Neyshabur
Province
Razavi Khorasan
Postal code
9319774448
Phone
+98 51 4262 3415
Email
mehrdad_mashhad74@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Neyshabour University of Medical Sciences
Full name of responsible person
Dr. Mostafa Arabi
Street address
Neyshabur University of Medical Sciences
City
Neyshabur
Province
Razavi Khorasan
Postal code
9319774448
Phone
+98 51 4330 6204
Email
marabi@nums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Neyshabour 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
Neyshabour University of Medical Sciences
Full name of responsible person
Mehrdad Rohaninasab
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Neyshabur University of Medical Sciences
City
Neyshabur
Province
Razavi Khorasan
Postal code
9188687975
Phone
+98 51 3609 3931
Email
mehrdad_mashhad74@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Neyshabour University of Medical Sciences
Full name of responsible person
Mehrdad Rohaninasab
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Neyshabur University of Medical Sciences
City
Neyshabur
Province
Razavi Khorasan
Postal code
9188687975
Phone
+98 51 3609 3931
Email
mehrdad_mashhad74@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Neyshabour University of Medical Sciences
Full name of responsible person
Mehrdad Rohaninasab
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Neyshabr University of Medical Sciences
City
Neyshabur
Province
Razavi Khorasan
Postal code
9188687975
Phone
+98 51 3609 3931
Email
mehrdad_mashhad74@yahoo.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
After collecting the data
When the data will become available and for how long
After printing the article
To whom data/document is available
Academic researchers and community members
Under which criteria data/document could be used
By mentioning the names of the authors of the present study
From where data/document is obtainable
neyshabur university of medical sciences
mehrdad rohaninasab 09156295519
mehrdad_mashhad74@yahoo.com
What processes are involved for a request to access data/document
Calling the author's phone or email or visiting Neishabur University of Medical Sciences in person