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Effect of Effleurage Massage on Sleep Quality and Self-efficacy of Multiple Sclerosis Patients in Shiraz Multiple Sclerosis Community 1391-92

Protocol summary

Summary
This study was performed to investigate the effect of Massage effleurage on Sleep Quality and efficacy in patients with multiple sclerosis a member of MS Shiraz society in 92-1391. The study included 80 patients with MS who were randomly divided into 2 groups Characteristics of patients. Intervention groups participated in 10 sessions, each session lasting 20 minutes and 2 times a weeks. For the control group, no intervention was not performed. Also, in the end of the intervention for patients in the control group was teaching massage. For inclusion of criteria was People (both sexes) aged 20 to 60 years with MS a member of MS Society of Shiraz,Developing MS than 6 months, Lack of stage disease attack, not receiving a massage During the past three months, no other chronic disease, lack of physical damage in the limbs and spine, non-pregnant women. If the patients with increasing severity of the disease that affects sleep quality and self-efficacy and Resulted in the patient being admitted to hospital,No follow-up and massaged by the patient for any reason, acute illness, such as fever, chills, severe pain, are excluded. Before the intervention, 5 and 10 weeks after treatment, sleep quality and self-efficacy in both groups was measured by the Pittsburgh Sleep Quality Questionnaire and general self efficacy.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013121015734N1
Registration date: 2015-05-10, 1394/02/20
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-05-10, 1394/02/20
Registrant information
Name
Mehdi Zarei
Name of organization / entity
Shiraz University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4252
Email address
zarei_mehdi@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shiraz University of Medical Science
Expected recruitment start date
2013-09-23, 1392/07/01
Expected recruitment end date
2013-12-22, 1392/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Effleurage Massage on Sleep Quality and Self-efficacy of Multiple Sclerosis Patients in Shiraz Multiple Sclerosis Community 1391-92
Public title
Effect of Effleurage Massage on Sleep Quality and Self-efficacy of Multiple Sclerosis Patients
Purpose
Supportive
Inclusion/Exclusion criteria
inclusion criteria: People (of both sexes) aged 20 to 60 years with MS in MS Society of Shiraz; Getting MS more than 6 months; Lack of stage of disease attack; Not receiving a massage in the last three months; No other chronic diseases; Lack of physical damage in the limbs and spine; non-pregnant women; No history of allergies; seizures and migraines; Not having any sores or lumps in organs; Not having surgery in the last 6 months. exclusion criteria: Increasing severity of the disease that affects sleep quality and self-efficacy of the patient and cause the patient's stay in hospital; Failure to follow Massage Program by the patient for any reason; Acute illness such as fever, chills, severe pain.
Age
From 20 years old to 60 years old
Gender
Both
Phase
2-3
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
Ethics Committee of Shiraz University of Medical Science
Street address
zand street
City
Shiraz
Postal code
Approval date
2013-09-23, 1392/07/01
Ethics committee reference number
279380

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
Before the intervention, 5 and 10 weeks after intervention
Method of measurement
Self-Efficacy Questionnaire

2

Description
Sleep Quality
Timepoint
Before the intervention, 5 and 10 weeks after intervention
Method of measurement
Pittsburgh Sleep Quality Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Control group: No intervention is not performed.
Category
N/A

2

Description
Experimental group: Effleurage massage 2 days in week for 10 weeks
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
MS Society of Fars
Full name of responsible person
Zeinab Mohebi
Street address
NO 216, Ghasredasht Street
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Shiraz University of Medical Science
Full name of responsible person
Seyed Basir Hashemi
Street address
Zand Street, Beside Red Cross, University Central Building, Shiraz University of Medical Sciences
City
Shiraz
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, Shiraz University of Medical Science
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
Shiraz University of Medical Science
Full name of responsible person
Zeinab Mohebi
Position
Master of Science
Other areas of specialty/work
Street address
Namazi Square, Collage of Nursing and Midwifery
City
Shiraz
Postal code
Phone
+98 71 3647 4251
Fax
Email
Zmohebi@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Science
Full name of responsible person
Zeinab Mohebi
Position
Master of Science
Other areas of specialty/work
Street address
College of Nursing and Midwifery, Namazee Squere
City
Shiraz
Postal code
Phone
+98 71 3647 4251
Fax
Email
Zmohebi@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Science
Full name of responsible person
Zeinab Mohebi
Position
Master of Science
Other areas of specialty/work
Street address
Collage of Nursing and Midwifery, Namazee Square
City
Shiraz
Postal code
Phone
+98 71 3647 4251
Fax
Email
Zmohebi@sums.ac.ir
Web page address

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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