Protocol summary

Summary
The aim of this study was to investigate the effect of self care education on the quality of sleep of multiple sclerosis patients. 50 multiple sclerosis patients from shiraz multiple sclerosis society were enrolled to receive eight sessions of self care educational program for three months. Primary outcome was quality of sleep patient's

General information

Acronym
Self care
IRCT registration information
IRCT registration number: IRCT2015060922630N1
Registration date: 2015-07-29, 1394/05/07
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-07-29, 1394/05/07
Registrant information
Name
Esmail Parsayee Manesh
Name of organization / entity
Jahrom University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 715440405
Email address
e.parsaeimanesh@jums.ac.ir
Recruitment status
Recruitment complete
Funding source
Jahrom University of Medical Sciense
Expected recruitment start date
2013-03-20, 1391/12/30
Expected recruitment end date
2013-03-20, 1391/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of self-care education on sleep quality for patients with multiple sclerosis in Jahrom
Public title
The effect of self-care education on sleep quality for patients with multiple sclerosis in Jahrom
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: presence of multiple sclerosis; ability to read and write. Exclusion criteria: presence of other diseases such as mental disorde; cognitive disorde; addiction or other neurologic disordres.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
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
Jahrom University of Medical Sciences
Street address
Jahrom Avenu Motahari
City
Jahrom
Postal code
24777123621
Approval date
2013-09-23, 1392/07/01
Ethics committee reference number
2020

2

Ethics committee
Name of ethics committee
Jahrom University of Medical Sciences
Street address
Jahrom, Motahari st.
City
jahrom
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
0715440405

Health conditions studied

1

Description of health condition studied
Multiple Sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple Sclerosis

Primary outcomes

1

Description
Quality of sleep
Timepoint
Immediately after the intervention
Method of measurement
Pittsburgh questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
In the intervention group, education based on steps of self care will be used for 2 month.
Category
Lifestyle

2

Description
Control group receive no intervention.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Jahrom Multiple Sclerosis Institute
Full name of responsible person
Esmail Parsayee Manesh
Street address
City
Jahrom

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Deputyof Jahrom University of Medical Sciense
Full name of responsible person
Dr Kavos Solh Joo
Street address
Jahrom University of Medical Sciences, Motahari st.
City
Jahrom
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputyof Jahrom University of Medical Sciense
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
Jahrom University of Medical Sciences
Full name of responsible person
Esmail Parsayee Manesh
Position
Faculty member
Other areas of specialty/work
Street address
Jahrom University of Medical Sciences, Motahari st.
City
Jahrom
Postal code
Phone
+98 71 5434 0405
Fax
+98 71 5434 0405
Email
e.parsaeimanesh@jums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Esmail Parsayee Manesh
Position
MSc
Other areas of specialty/work
Street address
Jahrom University of Medical Sciences, Motahari st.
City
Jahrom
Postal code
Phone
+98 71 5434 0405
Fax
+98 71 5434 0405
Email
e.parsaeimanesh@jums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Esmail Parsayee Manesh
Position
MSc
Other areas of specialty/work
Street address
Jahrom University of Medical Sciences , Motahari Street.
City
Jahrom
Postal code
Phone
+98 71 5434 0405
Fax
+98 71 5434 0405
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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