The aim of this study is to examine the effect of life skills training on self-management and coping with MS. The sample size would be 80. The study involved two groups: experimental and control and The study not blinded. The samples will be recruited by convenience sampling and and allocated to each groups by block randomization. Data collection tools include three questionnaires: (Personal and medical information questionnaire and coping and self-management questionnaires) will be completed by subjects before intervention. Coping and self-management questionnaires will be again completed, eighth weeks after intervention. Intervention includes a 4 teaching sessions over 4 weeks (1 session per week) with each session lasting 30 minutes and number of sessions may be increased if necessary. At the same time, the booklet and CD will be given to experimental group. During the study, the sample will be excluded if doesn’t attend at least one teaching sessions.In cases of acute illness or inability to attend training sessions, the potential participants would be excluded. The subjects in control group will receive usual care. primary outcome 1&2 involved :Coping and self-management.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016022326726N1
Registration date:2016-10-31, 1395/08/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-10-31, 1395/08/10
Registrant information
Name
Mahnaz Seyedoshohadaee
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4365 1000
Email address
seyedoshohadaee.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research Iran University of Medical Sciences
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2016-07-22, 1395/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of life skills training on self - management and coping of patients with Multiple sclerosis
Public title
The effect of life skills training on self - management and coping of patients with Multiple sclerosis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: a definite diagnosis of MS by a neurologist ability to read and write; ability to participate in training sessions; negative history of any exacerbation of the disease over the past three months; not being pregnant; not changing the dose of drugs in use; the absence of chronic cardiopulmonary diseases and psychological disorders .
Exclusion criteria: admission to hospital or recurrence of the disease; not attending at least one teaching session; developing a progressive type of MS; having excessive fatigue that makes the patient unable to receive the training; serious medical conditions.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Iran University of Medical Sciences
Street address
Besides Milad Tower, Hemmat Highway, Tehran
City
Tehran
Postal code
Approval date
2016-04-20, 1395/02/01
Ethics committee reference number
ir.iums.rec.1394.9311686009
Health conditions studied
1
Description of health condition studied
G35
ICD-10 code
G35
ICD-10 code description
Demyelinating diseases of the central nervous system
Primary outcomes
1
Description
Coping
Timepoint
The first day and a month after the last training session
Method of measurement
questionnaire
2
Description
self management
Timepoint
The first day and a month after the last training session
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Group test: 4 sessions over 4 weeks (1 session per week) with each session lasting 30 minutes for patients in the intervention group (the number of sessions may be added if necessary). The booklet and CD will be given to experimental group. Teaching manual has been prepared based on scientific content as follows: Session I: Multiple sclerosis, and its nature, life skills training concept and its applications, self-awareness skill, session II: Teaching empathy, interpersonal relationships and effective communication, session III: Reminders of previous content and skill training of coping with stress, emotion management, problem solving, session IV: browsing, teaching decision-making skills, creative thinking and critical thinking. In the session IV: Reminders of previous content and teaching decision making, innovative thinking and critical thinking skills. Teaching would be provided by the main researcher in the form of lecture, discussion and Q & A.
Category
Behavior
2
Description
The control group: received usual care and research tools will be given to them.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
MS Society in Tehran
Full name of responsible person
Head of the Center
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research Iran University of Medical Sciences
Full name of responsible person
Vice chancellor for Research Iran University of Medical Sciences
Street address
Besides Milad Tower, Hemmat Highway, Tehran
City
Tehran
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 Iran University of Medical Sciences
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
Iran University of Medical Sciences
Full name of responsible person
Shima Parnian
Position
Masters Student
Other areas of specialty/work
Street address
School of Nursing and Midwifery in Iran, Yassami Rasheed Street, higher than Damad, Vali Asr Ave.