The aim of this study was to investigate the effect of progressive muscle relaxation technique on fatigue and sleep disorders of multiple sclerosis patients. Sixty seven patients with multiple sclerosis from Yavar multiple sclerosis society (Gorgan city) were enrolled to receive educational program for 7 weeks. The study was performed in single group, before and after the intervention. Inclusion criteria: Ability to read and write, living in Gorgan city, membership of the MS Society and exclusion criteria: Presence of other diseases such as mental disorder, or other neurologic disorders, and addiction. Data collection tools were Pittsburgh sleep quality Index and fatigue severity scale questionnaire that were completed by patients before and after intervention. The primary outcome was fatigue severity and secondary outcome was sleep quality of patients with multiple sclerosis.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015081223600N1
Registration date:2015-09-08, 1394/06/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-09-08, 1394/06/17
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
Vice chancellor for research, Islamic Azad university Tehran, medical branch
Expected recruitment start date
2014-09-06, 1393/06/15
Expected recruitment end date
2015-01-05, 1393/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of applying progressive muscle relaxation technique on fatigue and sleep quality of patients with multiple Sclerosis
Public title
Effects of muscle relaxation technique on fatigue and sleep in multiple sclerosis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Ability to read and write, living in Gorgan city, membership of the MS Society
Exclusion criteria: Presence of other diseases such as mental disorder, or other neurologic disorders, addiction
Age
From 79 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
67
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Islamic Azad University Tehran Medical Branch ethics committee
Street address
Khaghani st. Shariati Ave. Tehran Medical Branch, Islamic Azad University, Tehran, Iran
City
Tehran
Postal code
1916893813
Approval date
2015-05-23, 1394/03/02
Ethics committee reference number
1069
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
sleep quality
Timepoint
50 days after Intervention
Method of measurement
Pittsburgh sleep quality Index
2
Description
fatigue severity
Timepoint
50 days after Intervention
Method of measurement
Fatigue severity scale questionnaire
Secondary outcomes
1
Description
demographic factors
Timepoint
50 days after intervention
Method of measurement
demographic factors questionnaire
Intervention groups
1
Description
Applying progressive muscle relaxation technique in 67 patients for 7 weeks in single group.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Yavar MS Society, Gorgan
Full name of responsible person
Vice chancellor for research, islamic azad university Tehran, medical branch
Street address
Khaghani st. Shariati Ave. Tehran Medical Branch, Islamic Azad University, Tehran, Iran
City
Gorgan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University Tehran Medical Branch
Full name of responsible person
Fateme Zargarani
Street address
Khaghani st. Shariati Ave. Tehran Medical Branch, Islamic Azad University, Tehran, Iran.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University Tehran Medical Branch
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
Tehran Medical Branch , Islamic Azad University
Full name of responsible person
Fateme zargarani
Position
Msc Student
Other areas of specialty/work
Street address
Khaghani st. Shariati Ave. Tehran Medical Branch, Islamic Azad University, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2200 6660
Fax
Email
f.zargarani@goums
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran Medical Branch , Islamic Azad University
Full name of responsible person
Fateme Zargarani
Position
Msc student
Other areas of specialty/work
Street address
Khaghani st. Shariati Ave. Tehran Medical Branch, Islamic Azad University, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2200 6660
Fax
Email
f.zargarani@goums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran Medical Branch , Islamic Azad University
Full name of responsible person
Fateme zargarani
Position
MSc student
Other areas of specialty/work
Street address
Khaghani st. Shariati Ave. Tehran Medical Branch, Islamic Azad University, Tehran, Iran
City
Tehran
Postal code
Phone
00
Fax
Email
f.zargarani@goums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)