Evaluation of quality of sleep, quality of life and fatigue of multiple sclerosis patients
Design
Clinical trial with community-based and pragmatic control group, with parallel, one-blinded, randomized, clinical trials, with a sample size of approximately 25
Settings and conduct
The interview , training session and intervention willbe conducted at rehabilitation faculty of Iran university of Medical Sciences.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patient with multiple sclerosis;
Age between 18-50;
EDSS score between 0-6;
Not having associated illness like depression;
Not having sleep medication;
exclusion criteria:
Failure to participate in the final evaluation;
Relapse the sign and symptom;
Intervention groups
intervention: a group of patient who receive special intervention for sleep and routine occupation therapy intervention
control group: Routine occupation therapy intervention
Main outcome variables
sleep quality; fatigue; quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120910010806N6
Registration date:2018-03-10, 1396/12/19
Registration timing:prospective
Last update:2018-03-10, 1396/12/19
Update count:0
Registration date
2018-03-10, 1396/12/19
Registrant information
Name
Malahat Akbarfahimi
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 7124
Email address
akbarfahimi.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-20, 1396/12/01
Expected recruitment end date
2018-06-22, 1397/04/01
Actual recruitment start date
2018-04-07, 1397/01/18
Actual recruitment end date
2018-07-23, 1397/05/01
Trial completion date
empty
Scientific title
The effect of sleep based occupational therapy intervention on quality of sleep, life and fatigue in patients with multiple sclerosis:
Public title
quality of sleep, life and fatigue in patient with multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patient with MS/ age
age between 18-50
EDSS between 0-6
no associated illness like depression
no taking sleep medication
Exclusion criteria:
Not attending the final evaluation session
Relapsing sign and /or symptoms
Age
From 18 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
25
Actual sample size reached:
20
Randomization (investigator's opinion)
Randomized
Randomization description
After review the medical records of patients with multiple sclerosis who refereed to the neurologist clinic in the past six months, patients who meet the inclusion criteria are selected. After obtaining the research criteria, participants are divided into two groups; intervention and control using lottery method of simple random sampling.
Blinding (investigator's opinion)
Single blinded
Blinding description
The evaluation is done by another person
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Mirdamad-Mother Square-Shahid Shah Nazari Avenue-Madadkaran Alley
City
Tehran
Province
Tehran
Postal code
15875-4391
Approval date
2017-01-02, 1395/10/13
Ethics committee reference number
IR.IUMS.REC 1395.9413355002
Health conditions studied
1
Description of health condition studied
Quality of sleep, quality of life and fatigue in multiple sclerosis patients
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
sleep Quality
Timepoint
Before intervention, after intervention
Method of measurement
Sleep quality questionnaire
2
Description
fatigue impact
Timepoint
Before intervention, after intervention
Method of measurement
Fatigue Impact Scale
3
Description
quality of life
Timepoint
Before intervention, after intervention
Method of measurement
Quality of Life Questionnaire SF-36
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: a group of patient who receive special intervention for sleep and routine occupation therapy intervention
Category
Treatment - Other
2
Description
Control group: Routine occupation therapy intervention
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Rehabilitation Sciences and Specialist Clinic
Full name of responsible person
Malahat Akbarfahimi
Street address
Mirdamad-Mother Square-Shahid Shah Nazari Avenue-Madadkaran Alley
City
Tehran
Province
Tehran
Postal code
15875-4391
Phone
+98 21 2222 7124
Fax
Email
akbarfahimi.m@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seid Kazem Malakoti
Street address
Mirdamad-Mother Square-Shahid Shah Nazari Avenue-Madadkaran Alley
City
Tehran
Province
Tehran
Postal code
15875-4391
Phone
+98 21 86701
Email
adminsite@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Malahat Akbarfahimi
Position
assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
Mirdamad-Mother Square-Shahid Shah Nazari Avenue-Madadkaran Alley
City
Tehran
Province
Tehran
Postal code
15875-4391
Phone
+98 21 2222 7124
Email
akbarfahimi.m@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Malahat Akbarfahim
Position
Assisstant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
Mirdamad-Mother Square-Shahid Shah Nazari Avenue-Madadkaran Alley
City
Tehran
Province
Tehran
Postal code
15875-4391
Phone
+98 21 2222 7124
Email
akbarfahimi.m@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Benyamin Kor
Position
MsC student
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
Mirdamad-Mother Square-Shahid Shah Nazari Avenue-madadkaran Alley
City
tehran
Province
Tehran
Postal code
15875-4391
Phone
+98 21 2222 7124
Email
benyamin.kor@gmail.com
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 of unwillingness of patients
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Data is MS patients whose information is not allowed to share
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Researchers working in academia and academia
Under which criteria data/document could be used
There is no permission to use the data for analysis
From where data/document is obtainable
akbarfahimi.m@iums.ac.ir
What processes are involved for a request to access data/document
Will be responded by sending a request by email in the shortest time