Multiple sclerosis (MS) is a chronic disease and a major source of disability across the world. Orem’s theory emphasizes an individual’s ability to self-care. Thus, the aim of the study was to examine the effects of an educational program based on Orem’s Self-care Theory on sleep quality and Some indicators of mental in patients with Multiple sclerosis.
The current clinical trial included 78 MS patients during 2014-15. The population included all MS patients registered at the MS Association of Zahedan who were invited to participate in the study through a public call. The objectives of the study were explained, and the ones willing and qualified according to inclusion criteria were registered. They were randomly allocated to a control and case group (n=39 in each group). The tools included a demographics form, Pittsburgh Sleep Quality Index Snyder’s Hope Scale,DASS21 and Patient Needs Assessment Form who were completed by the patients before and three months after the educational intervention. The intervention involved nine educational sessions based on Orem’s theory. Application of the program materials during the three months of education by patients was followed through self-report forms. Both needs assessment and self-report forms were researcher-made.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015050522100N1
Registration date:2015-08-21, 1394/05/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-08-21, 1394/05/30
Registrant information
Name
Hanie Dahmardeh
Name of organization / entity
Birjand University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 915 014 2934
Email address
mkhodabakhshi@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Birjand University of Medical Sciences and Health Services
Expected recruitment start date
2015-02-19, 1393/11/30
Expected recruitment end date
2015-03-21, 1394/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of self care program based on Orem's theory on the quality of sleep and psychological indices in patients with multiple sclerosis
Public title
The effect of self-care program on quality of sleep and Some indicators of mental in patients with multiple sclerosis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:age between 20-50; Literacy; lack of continuous use of sleep medication; sleep quality score of five or higher devices; independent of the wheelchair; not in the acute phase of the disease; the lack of other acute disorders or chronic physical and mental or psychological such as depression; impaired speech or hearing.
Exclusion criteria: lack of willingness to continue participation in the trial for any reason; patients who have complications during the intervention; physical-mental disorders and diseases are serious.
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Not 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
Birjand University Of Medical Sciences and Health Services
Street address
Ghaffari Street, Birjand
City
Birjand
Postal code
Approval date
2015-04-06, 1394/01/17
Ethics committee reference number
IR.BUMS.1394.1
Health conditions studied
1
Description of health condition studied
multiple scelerosis
ICD-10 code
G35
ICD-10 code description
multiple scelerosis
Primary outcomes
1
Description
Quality of sleep
Timepoint
Early intervention and 3 months
Method of measurement
Pittsburgh Sleep Quality Index...
2
Description
Hope
Timepoint
3 months
Method of measurement
Schneider hopes questionnaire
Secondary outcomes
1
Description
Some mental health indicators
Timepoint
Early intervention and 3 months
Method of measurement
Schneider hopes questionnaireDASS21،
Intervention groups
1
Description
Intervention group: Patients in the intervention group completed the questionnaire and 45-minute sessions over a two-week training program in 9th place, with medical supervision neurologist offered to them.
In the meetings, after additional details about the research and its objectives in the form of self reported by patients and care program on how to register will be explained to them in this form. Then the content of the curriculum as defined by the disease, its causes and symptoms, methods of diagnosis and treatment and self-care skills related to physical problems and muscle weakness, fatigue and how to relieve muscle spasms, gait disorders, urination and defecation disorders, disorder physical and cognitive performance and mental disorders will be presented.
The program will be presentations and displays images of patients are taught and trained for the review of cases will be considered for the patient questions to be answered. Patients were followed for 3 months after intervention and support researcher training program to run daily on Czech daily list of self-reported home pay and complete the. Researcher on a specific day in the community and patients will be able to attend your questions and problems to ask her in person or by phone. After three months, people will be invited to attend the forum. Then the questionnaires completed by the participants
Category
Rehabilitation
2
Description
Control group:
Patients in the control group completed questionnaires at baseline and these patients will not be any interference. After three months, the control group will be invited to attend forums and questionnaires completed by patients.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
MS Society Of Zahedan
Full name of responsible person
Mr. Dorrani
Street address
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences and Health Services
Full name of responsible person
Mr. Afkar
Street address
Ghaffari Street- Birjand
City
Birjand
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 and Health Services
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
Birjand University Of Medical Sciences
Full name of responsible person
Hanie Dahmardeh
Position
Graduate Student
Other areas of specialty/work
Street address
Alborz, Zibashahr, Zahedan.
City
Zahedan
Postal code
9817964884
Phone
+54 33281359
Fax
Email
www.Haniedahmardeh@gmail
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University Of Medical Sciences.
Full name of responsible person
Seyyed Abolfazl Vagharseyyedin
Position
Assistant Professor
Other areas of specialty/work
Street address
Ghafari street, Birjand
City
Birjand
Postal code
Phone
+98 915 362 4605
Fax
Email
vaghars@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Hanie Dahmardeh
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)