Protocol summary

Study aim
Study of the Effects of planned and written educating on anxiety of neurosurgical patients
Design
The method of this study was a pre and post experimental design on 90 patients (the sample size was determined in each group of 27 patients, but we selected 30 patients in each group). The candidate was randomly assigned using a table in 3 groups of program education Scheduled, written and checked. All patients responded to the Spielberger questionnaire 40 questions of anxiety and then were divided into two groups of planned and written instructional intervention. Then, the anxiety level of patients after training was re-evaluated in the three groups.
Settings and conduct
Imam Reza Hospital, Birjand city, will be the site of the study.
Participants/Inclusion and exclusion criteria
Inclination to participate in the study, aged over 18 and under 65, having reading and writing skills
Intervention groups
Simple and understandable language pamphlet was already prepared to the written group patients. in planned educating Socratic method and progress is from easy steps to wards the more difficult ones, and educational materials was taught to the audience for staging (from easy to difficult). Each stage requires the active participation of the audience to fill in the blanks of a written, solve a problem and answer a question. The control group was given no training, and then anxiety questionnaire was completed in each three groups after training.
Main outcome variables
Anxiety, age, gender, educational level

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180423039392N1
Registration date: 2018-05-23, 1397/03/02
Registration timing: retrospective

Last update: 2018-05-23, 1397/03/02
Update count: 0
Registration date
2018-05-23, 1397/03/02
Registrant information
Name
Hojat Ghaffari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3258 4980
Email address
hojatghaffary@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-04-21, 1394/02/01
Expected recruitment end date
2015-11-22, 1394/09/01
Actual recruitment start date
2015-04-21, 1394/02/01
Actual recruitment end date
2015-11-22, 1394/09/01
Trial completion date
empty
Scientific title
Study of the Effects of planned and written educating on anxiety of neurosurgical patients
Public title
Study of the Effects of planned and written educating on anxiety of neurosurgical patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The desire to participate in the study age range of 18 to 65 years having read and write ability
Exclusion criteria:
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: 27
Actual sample size reached: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment method 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 Birjand University of Medical Science
Street address
Birjand University of Medical Science.,Ghaffari Ayatollah Ave.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Approval date
2016-03-12, 1394/12/22
Ethics committee reference number
ir.bums.RCE.1394.434

Health conditions studied

1

Description of health condition studied
Neurosurgical patients
ICD-10 code
F43.0
ICD-10 code description
Acute stress reaction

Primary outcomes

1

Description
The amount of anxiety by number using the Spielberger questionnaire
Timepoint
Acceptance in the surgical section of the nerves until about half an hour ago surgery
Method of measurement
Spiel berger Anxiety Inventory

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: A planned education that is based on the Socratic method and progress from the easy steps to the difficult stages, and the teaching materials were staged (easy to difficult) to the learner. Each of the steps required an active engagement of the audience, and active participation was to fill the empty spaces of a single article, solve a problem, and answer a question.
Category
N/A

2

Description
Intervention group: A written teaching group that received educational materials through pamphlets and benches.
Category
N/A

3

Description
Control group: No training received.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital in Birjand
Full name of responsible person
Hojat Ghaffari
Street address
Ayatollah Taleghani Ave
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5000
Email
hojatghaffary@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr. Tooba Kazemi
Street address
Ayatollah Ghaffari Ave
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3244 0388
Email
Research@bums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Hojat Ghaffari
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
50 Plaque., 18 Tabataei., Asqrea Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9157658538
Phone
+98 51 3258 4980
Email
hojatghaffary@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Hojat Ghaffari
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
50 Plaque., 18 Tabataei., Asqrea Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9157658538
Phone
+98 513258480
Email
hojatghaffary@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Hojat Ghaffari
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
50 Plaque., 18 Tabataei., Asqrea Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9157658538
Phone
+98 51 3258 4980
Email
hojatghaffary@gmail.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
Potential data can be shared after unidentifiable people
When the data will become available and for how long
Start the access period 1 month after printing results
To whom data/document is available
For scholars working in academia and academia
Under which criteria data/document could be used
In planning for teaching patients in hospitals and health centers
From where data/document is obtainable
hojat ghaffari hojatghaffary@gmail.com
What processes are involved for a request to access data/document
Letter of introduction from college or research centers
Comments
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