Protocol summary

Summary
The present study has been done to determine the effectiveness of Progressive Muscle Relaxation on self efficacy and quality of life of family caregivers of patients with multiple sclerosis. Intervention under study was doing 90 sessions progressive muscle relaxation for three months and the primary outcome was self efficacy and secondary outcome was quality of life of caregivers.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138903042861N6
Registration date: 2010-07-01, 1389/04/10
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-07-01, 1389/04/10
Registrant information
Name
Reza Masoodi
Name of organization / entity
Nursing department, Shahrekord University of Medical Science,
Country
Iran (Islamic Republic of)
Phone
+98 38 1333 5654
Email address
masoodi@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahrekord University of Medical Sciences and Health Services
Expected recruitment start date
2009-06-05, 1388/03/15
Expected recruitment end date
2009-07-09, 1388/04/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of progressive Muscle Relaxation program on self efficacy and Quality of life in caregivers of patients with multiple sclerosis
Public title
The effect of progressive Muscle Relaxation program on self efficacy and Quality of life in caregivers of patients with multiple sclerosis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: living with patient, having a merit of decision for patients, having a responsibility of patients care Exclusion criteria: Presence of other diseases such as mental disorder, cognitive disorder, addiction, or other neurologic disorder
Age
From 20 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
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
Shahrekord University of Medical Sciences and Health Services
Street address
Shahrekord University of Medical Sciences and Health Services, Rahmatie, Shahrekord
City
Shahrekord
Postal code
8813833435
Approval date
2008-12-11, 1387/09/21
Ethics committee reference number
21/آپ

Health conditions studied

1

Description of health condition studied
Multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Demyelinating diseases of the central nervous system

Primary outcomes

1

Description
Self efficacy
Timepoint
Baseline and 3 months after intervention
Method of measurement
Questionnair

Secondary outcomes

1

Description
Quality of life
Timepoint
Baseline and 3 months after intervention
Method of measurement
Questionnaire

Intervention groups

1

Description
progressive Muscle Relaxation: 90 sessions each 45 minutes, for three months
Category
Rehabilitation

2

Description
No intervention in Control Group
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Kashani Hospital Clinic
Full name of responsible person
Reza Masoodi
Street address
Kashani Hospital, Parastar Street, Shahrekord
City
Shahrekord

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahrekord University of Medical Sciences and Health Services
Full name of responsible person
Reza Masoodi
Street address
Nursing department, Shahrekord University of Medical Sciences, Rahmatie
City
Shahrekord
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahrekord 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

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahrekord University of Medical Sciences and Health Services
Full name of responsible person
Reza Rasoodi
Position
Member of Faculty and PH.D Student in Nursing
Other areas of specialty/work
Street address
Nursing department, Shahrekord University of Medical Sciences, Rahmatie
City
Shahrekord
Postal code
8813833435
Phone
+98 38 1333 5653
Fax
+98 38 1334 6714
Email
masoodi@skums.ac.ir-masoodi1383@yahoo.com
Web page address
www.skums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahrekord University of Medical Sciences and Health Services
Full name of responsible person
Reza Masoodi
Position
Ph.D student of Nursing and Member of Faculty of Shahrekord University
Other areas of specialty/work
Street address
Nursing department, Shahrekord University of Medical Sciences, Rahmatie
City
Shahrekord
Postal code
8813833435
Phone
+98 38 1333 5653
Fax
+98 38 1334 6714
Email
masoodi@skums.ac.ir-masoodi1383@yahoo.com
Web page address
www.skums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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