50 patients with MS were randomly divided into two groups (intervention= 25) and (control= 25). For the intervention group, teaching relaxation techniques will be done as a team work for 4 days.Then this technique will be practice at home by the patients ,30 to 45 minutes , for two months. In the control group there was no intervention. After the necessary training and creating relaxation in the intervention groups, the quality of sleep and fatigue will be assessed before and after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015112923600N2
Registration date:2016-03-15, 1394/12/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-03-15, 1394/12/25
Registrant information
Name
Fateme Zargarani
Name of organization / entity
Tehran Medical Branch , Islamic Azad University
Country
Iran (Islamic Republic of)
Phone
+98 17 3254 4924
Email address
f.zargarani@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of research and technology, Golestan University of Medical Science
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-06-21, 1395/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Progressive Muscle Relaxation Technique on the quality of sleep and fatigue in patients with multiple Sclerosis
Public title
The Effect of Progressive Muscle Relaxation Technique on the quality of sleep and fatigue
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Having age between 15 to 60 years, Ability to read and write, Not in the acute phase, Living in Gorgan, EDSS desired Expanded Disability Status (Score between 0 and 5.5)
Exclusion criteria: Drug addiction, Relapse in three months, Not participating in meetings, Withdrawal from continuing to work for any reason, History of relaxation techniques, The risk of other serious health disorders, Serious psychiatric disorder, Sedating medications
Age
From 15 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Ethics Committee of the Golestan University of Medical Sciences
Street address
Golestan university of Medical Scinece, Deputy of research and technology
City
Gorgan
Postal code
Approval date
2015-11-22, 1394/09/01
Ethics committee reference number
IR.GOUMS.REC.1394.198
Health conditions studied
1
Description of health condition studied
quality of sleep and fatigue
ICD-10 code
F10-F19
ICD-10 code description
Mental and behavioural disorders
Primary outcomes
1
Description
sleep quality
Timepoint
Before and after intervention
Method of measurement
Pittsburgh Sleep Quality Index
2
Description
Fatigue
Timepoint
Before and after intervention
Method of measurement
Fatigue severity scale index
Secondary outcomes
1
Description
The recurrence rate in the last year
Timepoint
At the beginning of the study
Method of measurement
According to the person
Intervention groups
1
Description
Intervention Group have 25 patient with MS. For the intervention group, learning relaxation techniques can be done as a group for 4 days.Techniques for homework at home by the patient for 30 to 45 minutes runs for two months
Category
Other
2
Description
In the control group there was no intervention
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
MS Society of Gorgan
Full name of responsible person
Fatemeh Zargarani
Street address
5 Azar Hospital
City
Gorgan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research and Technology- Golestan University of Medical Sciences
Full name of responsible person
Fatemeh Zargarani
Street address
Deputy of Research and Technology, Golestan University of Medical Sciences
City
Gorgan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research and Technology- Golestan 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
Deputy of Research and Technology- Golestan Reaserch Center of Psychiatry
Full name of responsible person
Fatemeh Zargarani
Position
Master of Science in Psychiatric Nursing
Other areas of specialty/work
Street address
5 Azar Hospital
City
Gorgan
Postal code
Phone
00981732220561- 00981732421660
Fax
Email
zargaranif@gmail.com ; zargaranif@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Deputy of Research and Technology- Golestan Research Center of Psychiatry
Full name of responsible person
Fatemeh Zargarani
Position
Master of Science in Psychiatric Nursing
Other areas of specialty/work
Street address
5 Azar Hospital
City
Gorgan
Postal code
Phone
+98 17 3222 0561
Fax
Email
zargaranif@gmail.com ; zargaranif@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Deputy of Research and Technology- Golestan University of Medical Sciences
Full name of responsible person
Fatemeh Zargarani
Position
Master of Science in Psychiatric Nursing
Other areas of specialty/work
Street address
5 Azar Hospital
City
Gorgan
Postal code
Phone
+98 17 3222 0561
Fax
Email
zargaranif@gmail.com ; zargaranif@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)