Protocol summary

Summary
The aim of this study was to determine the effect of behavior –cognition group instruction based on the positive self-talking and body –relaxing and their combination on social phobia of nursing students. Inclusion and exclusion criteria: inclusion criteria to this study include; Nursing students with 22-18 years old who desired to take part in the plan, were eligible for social phobia criteria, attend the educational courses regularly and the exclusion criteria the study includes Nursing students who no desire for participating in the plan, nursing students not eligible for the criterion of the social phobia, didn’t participate in the educational courses regularly. The study of population: statistical universe contains all of the nursing students who were studying in nursing and midwifery faculty of Islamic Azad university Najaf Abad branch in school year of 2012-2013 the characteristics of under survey departments. The sample size: all of the 48 cases with phobia disorder were screened using social phobia questionnaire and substituted as random and equal into three subjective groups and an evidence group (each group involving 12 persons). Intervention: Tool of study related to Social Phobia questionnaire were used. subjective groups including body-relaxing, positive self-talking and their combination went under the behavior –cognition instruction during 16 therapy sessions as two –one hour –sessions per week. While the evidence group didn’t receive any intervention, Post –test and following (two months later) were done using the same tools. outcome: Finally, the student’s social phobia were compared in groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013050213204N1
Registration date: 2013-05-29, 1392/03/08
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-05-29, 1392/03/08
Registrant information
Name
Maryam Moghimian
Name of organization / entity
Islamic Azad University Najafabad Branch
Country
Iran (Islamic Republic of)
Phone
+98 31 1260 2411
Email address
m-moghimian@iaun.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research Islamic Azad University Najaf Abad Branch
Expected recruitment start date
2013-01-20, 1391/11/01
Expected recruitment end date
2013-06-20, 1392/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of behavior- cognition group instruction based on positive self-talking and body-relaxing and their combination on social phobia
Public title
The effect of behavior- cognition group instruction based on positive self-talking and body-relaxing and their combination on social phobia
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria to this study include; Nursing students with 22-18 years old who desired to take part in the plan, were eligible for social phobia criteria, attend the educational courses regularly and the exclusion criteria the study includes Nursing students who no desire for participating in the plan, nursing students not eligible for the criterion of the social phobia, didn’t participate in the educational courses regularly.
Age
From 18 years old to 22 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 48
Randomization (investigator's opinion)
Randomized
Randomization description
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 the Islamic Azad University Najafabad Branch
Street address
Ethics Committee, Vice chancellor for research, Islamic Azad University Najafabad Branch, Najafabad, Esfahan
City
Esfahan
Postal code
Approval date
2013-02-19, 1391/12/01
Ethics committee reference number
1229

Health conditions studied

1

Description of health condition studied
Social Phobia
ICD-10 code
F40- F48
ICD-10 code description
Neurotic, stress-related and somatoform disorders

Primary outcomes

1

Description
Social Phobia
Timepoint
Intervention, Immediately After The Intervention, Two Months After The Intervention
Method of measurement
Social Phobia Inventory

Secondary outcomes

1

Description
No
Timepoint
No
Method of measurement
No

Intervention groups

1

Description
Three experimental groups: Group Training of body-relaxing and positive self-talking and their combination during 16 therapy sessions as two – one hour – sessions per week
Category
Behavior

2

Description
The control group did not receive the Iintervention
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
School of Nursing and Midwifery, Najafabad Branch, Islamic Azad University
Full name of responsible person
Maryam Moghimian
Street address
School of Nursing and Midwifery, Islamic Azad University Najafabad Branch,Najafabad, Esfahan
City
Esfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research Islamic Azad University Najaf Abad Branch
Full name of responsible person
Reza Ebrahimi
Street address
Vice chancellor for research Islamic Azad University Najafabad Branch,Najaf Abad, Esfahan
City
Esfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research Islamic Azad University Najaf Abad Branch
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University Najafabad Branch
Full name of responsible person
Maryam Moghimian
Position
Msc
Other areas of specialty/work
Street address
N202, Ghadir 8, Eastern Hashtbehesht Av, Esfahan
City
Esfahan
Postal code
Phone
+98 31 1260 2411
Fax
Email
m-moghimian@iaun.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University Najafabad Branch
Full name of responsible person
Maryam Moghimian
Position
Msc
Other areas of specialty/work
Street address
N202, Ghadir 8, Eastern Hashtbehesht Av, Esfahan
City
Esfahan
Postal code
Phone
+98 31 1260 2411
Fax
Email
m-moghimian@iaun.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University Najafabad Branch
Full name of responsible person
Maryam Moghimian
Position
Msc
Other areas of specialty/work
Street address
N202, Ghadir 8, Eastern Hashtbehesht Av, Esfahan
City
Esfahan
Postal code
Phone
00
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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