Determination the effect of breathing yoga “Bhramary Pranayama” on fatigue and depression in patients with multiple sclerosis
Design
A randomized clinical trial with a parallel group design of 80 patients
Settings and conduct
In this randomized clinical trial, the study population are patients with multiple sclerosis who will referred to M.S association of Rafsanjan. Participants will select by convenience sampling method based on inclusion criteria of the study. Random allocation of the participants will carry out using the minimization method. The intervention group performed Bramari Pranayama yoga and the control group received usual care. Demographic questionnaire and the FSS and Beck depression questionnaires are data collection tool which will completed before the intervention and 28 days after the intervention in both groups.
Participants/Inclusion and exclusion criteria
Having relapsing-remitting MS, EDSS score less than 4, age between 18-60 years old, confirmation of M.S by a neurologist, getting score above 36 from the FSS questionnaire, getting score above 14 from Beck questionnaire and ability to do yoga independently are inclusion criteria.Having other neurological diseases except M.S, suffering from other diseases such as cancer, autoimmune diseases, cognitive problems and use of drugs or alcohol are exclusion criteria.
Intervention groups
Intervention group: For 4 weeks, they will do Bramari Pranayama yoga twice a day (morning and evening) for 20 minutes each time.
Control group: will receive the usual care of the community.
Main outcome variables
Fatigue Depression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150713023190N14
Registration date:2023-07-22, 1402/04/31
Registration timing:retrospective
Last update:2023-07-22, 1402/04/31
Update count:0
Registration date
2023-07-22, 1402/04/31
Registrant information
Name
Tabandeh Sadeghi
Name of organization / entity
Rafsanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3425 5900
Email address
t.sadeghi@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-01, 1402/04/10
Expected recruitment end date
2023-07-03, 1402/04/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the effect of breathing yoga “Bhramary Pranayama” on fatigue and depression in patients with multiple sclerosis
Public title
The effect of breathing yoga “Bhramary Pranayama” on fatigue and depression in patients with multiple sclerosis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having relapsing-remitting M.S
EDSS score less than 4
Age between 18-60 years old
Confirmation of M.S by a neurologist
Getting a score above 36 from the FSS questionnaire
Getting a score above 14 from Beck questionnaire
Ability to do yoga independently
Exclusion criteria:
Having other neurological diseases except M.S
Suffering from other diseases such as cancer, autoimmune diseases and cognitive problems.
Use of drugs or alcohol
Age
From 18 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
Stratified randomization by minimization method: in this method, initially, the patients will categorize based on key variables, such as scores from fatigue severity scale and depression questionnaires. Afterwards, from the
patients who will meet the inclusion criteria, the first participant will place in the intervention or control group by coin flip, and other participants will allocate to the study group with lower total of variables. The variables will stratify according to the following table :
Variables Category Intervention group Control group
Depression
questionnaire
score 14-19
20-28
29-63
Fatigue Severity Scale
(FSS) questionnaire
score 36-49
50-63
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 Rafsanjan University of Medical Sciences
Street address
Imam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Approval date
2023-06-14, 1402/03/24
Ethics committee reference number
IR.RUMS.REC.1402.036
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 the intervention and 28 days after the intervention
Method of measurement
Fatigue Severity Scale
2
Description
Depression
Timepoint
Before the intervention and 28 days after the intervention
Method of measurement
Beck Depression Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For 4 weeks, they will do Bramari Pranayama yoga twice a day (morning and evening) for 20 minutes each time. In the Bramari Pranayama, the participants will sit in a comfortable position with eyes closed and will instructed to close both ears using their index fingers. The subjects will instructed to concentrate on their breathing pattern and maximum inhalation through both the nostrils followed by maximum exhalation. During exhalation, the subject will asked to chant the word “Mmmm” in such a way that the humming bee sound brought vibration in their laryngeal walls.
Category
Treatment - Other
2
Description
Control group: Will receive the usual care (Medical, pharmaceutical and financial support, recreational programs) of the M.S association.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Rafsanjan MS association
Full name of responsible person
Fatemeh Ayoubi
Street address
Shariati Ave
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0001
Email
ayoobi.fatemeh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Reza Vazirinejad
Street address
Imam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0097
Email
vcrt@rums.ac
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Tabandeh Sadeghi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Parastar Ave
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3425 5900
Email
t.b_sadeghi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Tabandeh Sadeghi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Parastar Ave
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
0098 34 342555900
Email
t.b_sadeghi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Tabandeh Sadeghi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Parastar Ave
City
Rafsanjan
Province
Kerman
Postal code
7718796755
Phone
+98 34 3425 5900
Email
t.b_sadeghi@yahoo.com
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