Protocol summary

Study aim
Determining the Effect of Social Skills Group Training on Social Anxiety in Patients with Multiple Sclerosis.
Design
The aim of this study was to evaluate the effect of social skills training on social anxiety in multiple sclerosis patients who went to Ahwaz MS community. The statistical population of the study is MS patients. The samples were selected using an available sampling method that had a high score in the social anxiety test, and divided into two groups of case and control. Data were collected using Watson & Fernd social anxiety questionnaire and Matson social skills questionnaire.
Settings and conduct
This study will be carried out at the Ahwaz community. The MS community was chosen because collecting samples is easier at this location due to the referral of patients. After receiving the ethics code from Ahvaz Jundishapur University , samples were sent to the MS society and samples are 66 according to the samples size. They were selected from available samples of, and then randomly divided into Case group and control group.
Participants/Inclusion and exclusion criteria
Inclusion: definite diagnosis of MS by a specialist, had MS attack at least twice, no previous psychiatric problems, ability to move, taking a minimum score of 12 in the social anxiety test. Exclusion criteria: have previous psychiatric problems. in less than three months have passed since their illness.
Intervention groups
The intervention groups consisted of two groups of case and control, which each of them are 33 people according to the sample size. Both groups received a high score from social anxiety test and randomly divided into two groups. The case group received social skills training in eight sessions, but control group did not receive such training.
Main outcome variables
Main variable: Social anxiety

General information

Reason for update
Acronym
Social anxiety
IRCT registration information
IRCT registration number: IRCT20171025037004N3
Registration date: 2018-11-23, 1397/09/02
Registration timing: retrospective

Last update: 2018-11-23, 1397/09/02
Update count: 0
Registration date
2018-11-23, 1397/09/02
Registrant information
Name
Sedigheh Nikzad
Name of organization / entity
Ahvaz Jundishapur University of Medical Scienes
Country
Iran (Islamic Republic of)
Phone
+98 61 3333 3477
Email address
nikzad.s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
This study is from research credit points Ahvaz Jundishapur University of Medical Sciences is provided.
Expected recruitment start date
2016-07-29, 1395/05/08
Expected recruitment end date
2016-09-20, 1395/06/30
Actual recruitment start date
2016-08-05, 1395/05/15
Actual recruitment end date
2016-10-31, 1395/08/10
Trial completion date
empty
Scientific title
The effect of group social skills education on social anxiety in multiple sclerosis.
Public title
The Effect of Social Skills Training on Anxiety
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive diagnosis of MS should be determined by a specialist physician and disease Had MS attack at least twice. Have no psychiatric problems Have the Ability to move Taking a minimum score of 12 in the social anxiety test.
Exclusion criteria:
Have previous psychiatric problems. Not able to move. Less than three months have passed since their illness.
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 66
More than 1 sample in each individual
Number of samples in each individual: 1
In this study, each person is just a sample.
Actual sample size reached: 66
More than 1 sample in each individual
Actual sample size in each individual: 1
In this study, each person is just a sample.
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was done using simple randomization method using dice.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This research plan has not been performed in MS patients so far, and due to the many problems of these patients, including social problems, performing such a plan is effective in reducing the social problems of these patients.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee Ahvaz Jundishapur University of Medical Sciences- Deputy of Development and Technol
Street address
Academic town, Golestan,Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
١٥٧٩٤-٦١٣٥٧
Approval date
2015-11-21, 1394/08/30
Ethics committee reference number
ajums.REC.1394.452

Health conditions studied

1

Description of health condition studied
Social anxiety
ICD-10 code
F40.1
ICD-10 code description
Social phobias

Primary outcomes

1

Description
Social Anxiety
Timepoint
Before the intervention and one month after the end of the intervention
Method of measurement
Watson & FreundS Social Anxiety inventory

Secondary outcomes

empty

Intervention groups

1

Description
At first Matson s social skills training, which includes dexterity skills, community, self- management skills and communication with peers, was In the intervention group was taught.The training was held in one session per a week and the last session was held one month later to see the effects of training.
Category
Behavior

2

Description
Control group: In the case of the control group, Watson s social phobia was answered by them and then, they did not receive special training. At the end, the social anxiety questionnaire was answered by the control group again.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
MS Forum- Faculty of Rehabilitation
Full name of responsible person
Ms Bahareh Nedamat
Street address
Shahre Danshgahee- Golestan- Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
١٥٧٩٤-٦١٣٥٧
Phone
+98 61 3333 3477
Fax
+98 61 3336 1544
Email
bahareh.nedamat65@gmail.com
Web page address
https://www.facebook.com/Google

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
University Development and Research Deputy
Street address
shahreh daneshgahhy-Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
061-33361544
Phone
+98 61 3333 3477
Fax
+98 61 3336 1544
Email
Hossein148@ymail.com
Web page address
https://mail.yahoo.com/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Sedigheh Nikzad
Position
Master of Science (MSc) in Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty oNursing & Midwifery-shahreh daneshgahhy-Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3333 3477
Fax
+98 61 3336 1544
Email
nikzad.s@ajums.ac.ir
Web page address
http://mail.ajums.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mr Hossein Komailly sany
Position
PHD
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
shahrehe daneshgahhy-Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 33333477
Fax
+98 61 3336 1544
Email
HosseinKomaili@gmail.com
Web page address
https://www.facebook.com/Google

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Sedigheh Nikzad
Position
Master degree Student of nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing- Jundishapur University- Academic City- Golestan- Ahwaz
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 33333477
Fax
+98 61 3336 1544
Email
nikzad.s@ajums.ac.ir
Web page address
http://mail.ajums.ac.ir/

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
Because the information of the participants is confidential and I do not have permission to publish.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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