Protocol summary

Summary
Introduction: Multiple sclerosis is a chronic and progressive disease that for some reasons, including unpredictability and incurability causes stress, anxiety and depression in patients. Therefore this study was designed to examine the impact of peer education program on stress, anxiety and depression in patients with multiple sclerosis. Method: This research is a semi-experimental study that includes two tests and control groups and non-random sampling that sample size in each group was 55 individuals. Data collection tool was questionnaire DASS21 that was to asses’ patients stress, anxiety and depression before and after 4 months and were completed by both groups. After preparing the peer group, six training sessions by peer group for test group was held during two months.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201202279154N1
Registration date: 2012-06-11, 1391/03/22
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-06-11, 1391/03/22
Registrant information
Name
Ali Dehghani
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 8288 3856
Email address
ali_dehghani1388@yahoo.com
Recruitment status
Recruitment complete
Funding source
Tarbiat Modares University
Expected recruitment start date
2011-02-26, 1389/12/07
Expected recruitment end date
2011-06-21, 1390/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Appling Peer Group Designed Education Plan on Stress, Anxiety and Depression of Multiple Sclerosis Patient
Public title
The effects peer group education on psychological symptoms in multiple sclerosis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: 1. Based on clinical findings, laboratory studies with MS are diagnosed by specialists. 2. Age is 20 to 45 years. 3. Expanded disability status scale score of the patient through the case study (EDSS) samples of 5 / 5-0 (a state of mild and moderate disability, illness) 4. Are literate. 5. At least 6 months have the disease. Exclusion criteria: 1. Patients with specific training in relation to other lifestyles, ways of coping with stress, anxiety and depression, spend, 2. To be suffering from other chronic disorders. 3. Certain changes in the lives of patients during the intervention or treatment process may have 4. Patients do not complete during the entire follow up period.
Age
From 20 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 110
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
tarbiat modares university
Street address
tarbiat modares university, jalal al ahmad, tehran
City
tehran
Postal code
1411845561
Approval date
2010-10-09, 1389/07/17
Ethics committee reference number
52/59729

Health conditions studied

1

Description of health condition studied
multiple sclerosis
ICD-10 code
G30 - G32
ICD-10 code description
Other degenerative diseases of the nervous system

Primary outcomes

1

Description
Anaxeity
Timepoint
before internention and after 4 months intervention
Method of measurement
questionnaire DASS21

2

Description
Depression
Timepoint
before internention and after 4 months intervention
Method of measurement
questionnaire DASS21

3

Description
Stress
Timepoint
before internention and after 4 months intervention
Method of measurement
questionnaire DASS21

Secondary outcomes

1

Description
Physical illness problems
Timepoint
Before intervention and 4 months after intervention
Method of measurement
Self - administraded questionnaire

Intervention groups

1

Description
The intervention used in this study were trained by the peer group that After preparing the peer group, six training sessions by peer group for test group was held during two months
Category
Behavior

2

Description
For the control group received no intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Center for Iranian MS Society
Full name of responsible person
multiple sclerosis patients
Street address
Center for Iranian MS Society, tehran
City
tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Mohammad Mosavi
Street address
Research assistance, Building No. 1, School of Medicine, tarbiat modares university, jalal al ahmad street, tehran (mr.mosavi)
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tarbiat Modares University
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
tarbiat modares university
Full name of responsible person
dr.robabeh memarian
Position
phd in nursing
Other areas of specialty/work
Street address
tarbiat modares university, jalal al ahmad street, tehran
City
tehran
Postal code
1411845561
Phone
+98 79 1334 1501
Fax
Email
memarian_r@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
tarbiat modares university
Full name of responsible person
dr simamohammad khan kermanshahi
Position
assisstant professor
Other areas of specialty/work
Street address
tarbiat modares university, jalal al ahmad street, tehran
City
tehran
Postal code
Phone
+98 2109125005629
Fax
Email
kerman_s@modares.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
tarbiat modares university
Full name of responsible person
ali dehghani
Position
msc in nursing
Other areas of specialty/work
Street address
tarbiat modares university, jalal al ahmad street, tehran
City
tehran
Postal code
Phone
+98 2109171238508
Fax
Email
ali_dehghani1388@yahoo.com
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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