Protocol summary

Study aim
Determining the Effect of Effective Communication Training on Nurses on the Rate of Preoperative Anxiety in Patients with High Risk of Cardio-Respiratory Surgery Determining the Effect of Effective Communication Training on Nurses on Postoperative Pain in Patients with High Risk of Cardio-respiratory Operations
Design
This is a controlled clinical trial of two groups that are performed sequentially.
Settings and conduct
This study is done in two periods of three months in Shohada Kargar Hospital, Yazd
Participants/Inclusion and exclusion criteria
Criteria for entry (patients); 1. Having high cardio-respiratory risk (according to cardiac or internal counseling) 2. The candidate for surgery is cholecystectomy 3. Be above 18 years of age    Exit criteria (patients); 1. Non-familiar with Persian language 2. Clinical psychological diseases 3. Drug Addiction 4. Emergency attendant
Intervention groups
Research samples are selected from patients admitted to the operating room for at least half an hour before surgery in the operating room filling room, in two consecutive 3-month intervals. During the first 3 months, the nurses who care for the samples did not undergo any training. Patients in this period will be considered as the control group. In the interval of three months, all nurses and operating room personnel will be trained by the professors to train communication techniques and care protocol based on effective communication with the patient and acquire the necessary skills. Patients selected in the second trimester are under the care of trained nurses and patients are considered as the test group.
Main outcome variables
Expected outcomes in this study were the change in preoperative anxiety and postoperative pain in patients with high risk cardiopulmonary bypass surgery under nurses' care

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190429043419N1
Registration date: 2019-06-03, 1398/03/13
Registration timing: retrospective

Last update: 2019-06-03, 1398/03/13
Update count: 0
Registration date
2019-06-03, 1398/03/13
Registrant information
Name
Mohsen Jalali ali abad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3827 5367
Email address
m.jalali@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-27, 1397/06/05
Expected recruitment end date
2019-01-25, 1397/11/05
Actual recruitment start date
2018-10-02, 1397/07/10
Actual recruitment end date
2019-04-04, 1398/01/15
Trial completion date
2019-04-04, 1398/01/15
Scientific title
Study of the Effect of Teaching on the Effective Communication of the Nurse on Preoperative Anxiety and Postoperative Pain in Patients with High Risk of Cardiopulmonary Bypass surgery in Shohada Kargar Hospital, Yazd
Public title
Investigating the Impact of Teaching Effective Communication to the Nurse
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having a high cardio respiratory risk (due to heart or internal counseling) Candidates are cholecystectomy Be over 18 years old
Exclusion criteria:
Unfamiliar with Farsi Infectious diseases Drug addiction Emergency patients
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Actual sample size reached: 80
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
This is a controlled clinical trial in two groups that are run sequentially

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee in Shahid Sadoughi University of Medical Sciences Yazd
Street address
Bahonar Square, Shahid Sadoughi University of Medical Sciences, Yazd
City
yazd
Province
Yazd
Postal code
8916978477
Approval date
2018-09-30, 1397/07/08
Ethics committee reference number
ir.ssu.rec.1397.078

Health conditions studied

1

Description of health condition studied
The Effect of Teaching Effective Communication to the Nurse on the Patient's Anxiety
ICD-10 code
ICD-10 code description

2

Description of health condition studied
Effect of teaching on the effective communication of the nurse on the patient's pain
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Effect of effective nursing on preoperative anxiety
Timepoint
Before and after intervention
Method of measurement
Self-Rating Anxiety Scale(SAS)

2

Description
Effect of teaching on the effect of nurses on postoperative pain
Timepoint
Before and after intervention
Method of measurement
Visual Analogue Scale (VAS)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The patients admitted to the operating room, which is cared in the pre operating room at least half an hour before surgery, selected through convenient sampling for three consecutive months after effective nurse communication training. All nurses and operating room personnel are trained by professors in communication and communication protocols based on effective communication with the patient and receive the necessary skills. These patients are under the care of trained nurses.
Category
Other

2

Description
Control group: The patients admitted to the operating room, which is cared in the pre operating room at least half an hour before surgery, selected through convenient sampling for three consecutive months before effective nurse communication training. These patients are under the care of untrained nurses.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Yazd Workers' Hospital
Full name of responsible person
Zohreh Kalani
Street address
Ave. Thaisar Fallahi, Bouali Ave. Nursing Midwifery Faculty
City
YAZD
Province
Yazd
Postal code
8916978477
Phone
+98 35 3824 1751
Email
kalanizohreh@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Massoud Mirzaei
Street address
Bahonar Square, Shahid Sadoughi University of Medical Sciences, Yazd
City
YAZD
Province
Yazd
Postal code
8916978477
Phone
+98 35 3724 0171
Email
mmirzaei@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Mohsen Jalali Ali Abad
Position
Master's degree nursing specialist
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Thaisar Fallahi St. Bouali Ave. Faculty of Nursing and Midwifery
City
YAZD
Province
Yazd
Postal code
8916978477
Phone
+98 35 3824 1751
Email
MOHSEN.JALALI.DAMOK@GMAIL.COM

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mohsen Jalali Ali Abad
Position
Student Master of Nursing Special Care
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Thaisar Fallahi St. Bouali Ave. Faculty of Nursing and Midwifery
City
yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3824 1751
Email
mohsen.jalali.damok@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mohsen Jalali Ali Abad
Position
Student Master of Science in Nursing Special Care
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Thaisar Fallahi St. Bouali Ave. Faculty of Nursing and Midwifery
City
yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3827 5367
Email
mohsen.jalali.damok@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
No more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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