The effect of Benson relaxation technique on fatigue and general health in multiple sclerosis patients admitted to kashan shahid beheshti hospital in 2017
Determining the effect of Benson relaxation technique on fatigue and general health in multiple sclerosis patients
Design
In this randomized clinical trial, patients will be randomly assigned to two groups of 30 people.
Settings and conduct
Benson relaxation technique will be performed in a room at Kashan Shahid Beheshti Hospital for 20 minutes for 4 weeks (daily, twice daily).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with Multiple Sclerosis Relapsing-Remitting؛ Type Age 20-45 years ؛Not having had any attacks in the past three months؛ Having the consent to participate in the study؛ No known psychiatric disorders, dementia and mental retardation.
Exclusion criteria: Use of other Complementary therapies
Intervention groups
In the intervention group, Benson relaxation technique will be performed for 20 minutes during 4weeks (daily, twice daily). The control group will be performed no intervention for 4 weeks.
Main outcome variables
Fatigue and general health
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111210008348N44
Registration date:2020-06-17, 1399/03/28
Registration timing:prospective
Last update:2020-06-17, 1399/03/28
Update count:0
Registration date
2020-06-17, 1399/03/28
Registrant information
Name
Neda Mirbagher
Name of organization / entity
Kashan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 0021
Email address
mirbagher_n@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2020-09-20, 1399/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Benson relaxation technique on fatigue and general health in multiple sclerosis patients admitted to kashan shahid beheshti hospital in 2017
Public title
The effect of Benson relaxation on fatigue and general health in multiple sclerosis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with Multiple Sclerosis Relapsing-Remitting Type
Age 20-45 years
No acute attack of multiple sclerosis in the last three months
Having the consent to participate in the study.
No known psychiatric disorders, dementia and mental retardation
Exclusion criteria:
Use of other Complementary therapies
Age
From 20 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation in two groups of intervention and control will be simple randomization. Randomization is carried out by creating a random sequence of numbers using on an line randomizer tool (https://www.randomizer.org).
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 Kashan University of Medical Sciences
Street address
Ravand Street, Kashan University of Medical Sciences.
City
Kashan
Province
Isfehan
Postal code
8715981151
Approval date
2017-08-16, 1396/05/25
Ethics committee reference number
IR.KAUMS.NUHEPM.REC.1396.31
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
Fatigue
Timepoint
Before and after intervention
Method of measurement
Brief Fatigue Inventory
Secondary outcomes
1
Description
General health
Timepoint
Before and after the intervention
Method of measurement
Goldberg General Health Questionnaire
Intervention groups
1
Description
Intervention group: In addition to routine care (physiotherapy, light exercise, medication), the Bensone relaxation technique will be performed for 4 weeks (every day, twice a day) for 20 minutes. The Benson's relaxation technique includes the following steps: Being comfortable, closing eyes, relaxing all the muscles of the body, breathing slowly.
Category
Treatment - Other
2
Description
Control group: Routine care including joint physiotherapy, light exercise, medication will be performed for patients by health personnel .
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Kashan Shahid Beheshti Hospital
Full name of responsible person
Neda Mirbagher
Street address
Ravand street,Shahid Beheshti Hospital
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Fax
+98 31 5554 6633
Email
mirbagher_n@kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamid Reza Banafsheh
Street address
Ravand Street, Kashan University Medical Sciences
City
kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Fax
+98 31 5554 6633
Email
salam_20012003@yahoo.co.uk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Neda Mirbagher
Position
Associate
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ravand Street, Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Fax
+98 31 5554 6633
Email
salam_20012003@yahoo.co.uk
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Neda Mirbagher
Position
Associate
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ravand street, Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
0098315540021
Email
salam_20012003@yahoo.co.uk
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Neda Mirbagher
Position
Associate
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ravand Street, Kashan University of Medical Sciences
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
salam_20012003@yahoo.co.uk
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available