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Effect of training on Anxiety, stress, pain management and some postoperative complications in abdominal surgery patients referring to Ali ibn Abitaleb Hospital in Rafsanjan in 2019

Protocol summary

Study aim
Effect of training on anxiety, stress, pain management and some postoperative complications in abdominal surgery patients
Design
The patients were Random block divided into 4 groups (1 control group and 3 intervention groups). Implementing educational interventions and evaluating the results.
Settings and conduct
A study at Ali ibn Abitaleb Hospital in Rafsanjan will be performed by class division and the intervention will be administered to patients in 48 hours before surgery.
Participants/Inclusion and exclusion criteria
Inclusion criteria: The age of 18-75 years old, elective surgery in the abdominal area, up to 46 hours after the operation in the hospital, the ability to understand and speak in Farsi, mental illness recorded, Lack of addiction to narcotics, lack of history of chronic pain  Exit criteria: Unwillingness of patients to continue the study, return to the operating room, confusion during the postoperative period, admission to the RCT, any factor that causes the patient to get out of reach 48 hours.
Intervention groups
Individual training 48 hours before surgery (intervention 1: by physician, intervention 2: by nurse and intervention 3: delivering educational pamphlet). The content of training in this section is related to the type of operation, the definition of pain, the types of pain, how Pain relief, pain relief and pain medication, such as music therapy, methods of deviation, reading, relaxation breathing exercises, undesirable effects of postoperative pain in the physical, emotional, economic, and early stages of life. Outdoors activities will last for 30 minutes Children. And in the control group, the usual care of abdominal surgery patients will be used. The control group will receive the usual care of abdominal surgery patients.
Main outcome variables
Anxiety, stress, pain management, postoperative complications

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180729040630N1
Registration date: 2019-02-18, 1397/11/29
Registration timing: prospective

Last update: 2019-02-18, 1397/11/29
Update count: 0
Registration date
2019-02-18, 1397/11/29
Registrant information
Name
Mohammad Ali Zakeri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3429 2316
Email address
mazakeri@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-21, 1398/01/01
Expected recruitment end date
2019-12-22, 1398/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of training on Anxiety, stress, pain management and some postoperative complications in abdominal surgery patients referring to Ali ibn Abitaleb Hospital in Rafsanjan in 2019
Public title
Effect of training on Anxiety, stress, pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Criteria for entering the study: Age between 18 and 75 years Patient with criteria for performing elective surgery in the abdomen To be hospitalized for up to 46 hours after surgery. Ability to understand and speak Persian Interested in participating in the study The absence of mental illness recorded in the case Able to communicate and understand the questionnaire Non-drug addiction and other narcotic drugs No history of chronic pain
Exclusion criteria:
Exit criteria: Unwillingness of patients to continue reading There is no problem as long as the patient is unable to continue studying Return to the operating room Confusion during the postoperative period Admission to the Intensive Care Unit Participate in another clinical trial at the same time Any factor that causes the patient to get out of reach 48 hours (lack of cooperation, early clearance, and personal satisfaction).
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 200
Randomization (investigator's opinion)
Randomized
Randomization description
Random block Patients will be divided into 4 blocks and in randomized layers with a level of education. Levels of classification based on the level of education in three levels (Illiterate, less than diploma and more than diploma).
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 Rafsanjan University of Medical Sciences
Street address
Imam Ali Blvd, Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Approval date
2019-01-21, 1397/11/01
Ethics committee reference number
IR.RUMS.REC.1397.186

Health conditions studied

1

Description of health condition studied
Abdominal pain
ICD-10 code
R10
ICD-10 code description
Abdominal and pelvic pain

2

Description of health condition studied
anxiety
ICD-10 code
F41
ICD-10 code description
Other anxiety disorders

3

Description of health condition studied
Stress
ICD-10 code
Z73.3
ICD-10 code description
Stress, not elsewhere classified

Primary outcomes

1

Description
pain management
Timepoint
After the intervention
Method of measurement
Revised American Pain Society Patient Outcome Questionnaire

2

Description
anxiety
Timepoint
Before and after intervention
Method of measurement
state-trait anxiety inventory

3

Description
emotional preoperative stress
Timepoint
Before intervention
Method of measurement
brief measure of emotional preoperative stress

Secondary outcomes

1

Description
postoperative complications
Timepoint
after intervention
Method of measurement
Report the type of postoperative complications

Intervention groups

1

Description
Intervention group: Training by a doctor (Training by physician  Individually, one session will be performed for 30 minutes 48 hours before surgery. Training includes providing comprehensive information about the type of surgery, the definition of pain, types of pain, the explanation of the causes of postoperative pain and emotion, the importance of pain control, pain management, how to reduce pain by pharmacological and non-pharmacological methods, and actions taken by The patient can be used to relieve pain).
Category
Treatment - Other

2

Description
Intervention group: Training by a nurse (Training by nurse Individually, one session will be performed for 30 minutes 48 hours before surgery. Training includes providing comprehensive information about the type of surgery, the definition of pain, types of pain, the explanation of the causes of postoperative pain and emotion, the importance of pain control, pain management, how to reduce pain by pharmacological and non-pharmacological methods, and actions taken by The patient can be used to relieve pain).
Category
Treatment - Other

3

Description
Intervention group: Training with pamphlets (Training Patients will be given a pamphlet within 48 hours before the surgery. Trainings include providing comprehensive information about the type of surgery, the definition of pain, types of pain, the explanation of the causes of postoperative pain and emotion, the importance of pain control, pain management, how to reduce pain by pharmacological and non-pharmacological methods, and actions taken by The patient can be used to relieve pain).
Category
Treatment - Other

4

Description
Control group: No training (In the control group the training will not be given).
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Ali-ibn abitaleb hospital , Rafsanjan, Iran
Full name of responsible person
Gholamreza Bazmandeghan
Street address
Imam Ali Blvd, Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0038
Fax
+98 34 3428 0071
Email
info@rums.ac.ir
Web page address
http://www.rums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Ali Shmsizadeh
Street address
Imam Ali Blvd - Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0097
Fax
+98 34 3428 0071
Email
alishamsy@gmail.com
Web page address
http://www.rums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Mohammad Ali Zakeri
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Ali-ibn abitaleb hospital , Rafsanjan, Iran
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34342316
Fax
+98 34 3428 0071
Email
mazakeri@rums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Mohammad Ali Zakeri
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Ali-ibn abitaleb hospital, Rafsanjan, Iran
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0038
Email
mazakeri@rums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Mohammad Ali Zakeri
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Ali-ibn abitaleb hospital, Rafsanjan, Iran
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0038
Fax
+98 34 3428 0071
Email
mazakeri@rums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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
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