Determining the effectiveness of a course of yoga exercises on depression and anxiety, balance and attention in patients with MS.
Design
This research has followed the Small Sample method and the study has been implemented in ABAB phases. So that phase A represents the baseline condition, and phase B represents the intervention status. The test has been conducted on 4 examinees, and during the research period, relevant tests are administered and recorded every 4 days to finally check the effectiveness of yoga exercises in the baseline and intervention phases.
Settings and conduct
In the baseline phase, the examinees are recording the desired tests every 4 days for a duration of 16 days without receiving any yoga exercises. In the intervention phase, for 24 days, the examinees are participating in 10 yoga training sessions, and the tests are being administered and recorded every 4 days.
This process will be repeated two consecutive times.
Participants/Inclusion and exclusion criteria
Inclusion criteria: not having the experience of practicing yoga or at least 6 months passed since last yoga course;
having the possibility to attend yoga classes.
Non-inclusion criteria: Inability to Participate in Face-to-Face Yoga Classes
Intervention groups
In this research, the effectiveness of a course of yoga exercises on depression and anxiety, balance and attention of patients with MS is being investigated. According to the ABAB plan, in each phase B or intervention, 10 sessions, examinees are being provided with 10 sessions of 90 minutes yoga exercises.
Main outcome variables
Depression; Anxiety; Balance; Attention
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230508058119N1
Registration date:2023-07-12, 1402/04/21
Registration timing:retrospective
Last update:2023-07-12, 1402/04/21
Update count:0
Registration date
2023-07-12, 1402/04/21
Registrant information
Name
Faezeh AliBakhshi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 4244 4225
Email address
faezehalibakhshi97@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-20, 1401/12/01
Expected recruitment end date
2023-03-14, 1401/12/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the Effectiveness of a Course of Yoga Exercises on Depression and Anxiety, Balance and Attention in Patients with MS.
Public title
The Effect of Yoga on the Complications of MS.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The examinee does not have the experience of practicing yoga or at least 6 months have passed since her last yoga course
The examinee has the possibility to attend yoga classes
Exclusion criteria:
Inability to Participate in Face-to-Face Yoga Classes
Age
From 30 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
4
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
Ethics committee of Islamic Azad University of Borujerd
Street address
No. 36, Pirasteh Alley, North Modares St , Nakhi Crossroad
City
Borujerd
Province
Lorestan
Postal code
6919753935
Approval date
2023-05-01, 1402/02/11
Ethics committee reference number
IR.IAU.B.REC.1402.030
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
d2 test score to measure the level of attention
Timepoint
Every 4 days since the beginning of the research
Method of measurement
d2 Attention test
2
Description
Berg and Bess test score to measure balance
Timepoint
Every 4 days since the beginning of the research
Method of measurement
Berg and Bess balance test
3
Description
GHQ mental health test score to measure the level of depression and anxiety
Timepoint
Every 4 days since the beginning of the research
Method of measurement
GHQ mental health test
Secondary outcomes
empty
Intervention groups
1
Description
In the present study, the Small Sample method is used for community experimentation. In this method, each participant acts as a unit of analysis and serves as their own control group. The method involves serial observations of the sample population, both individually and in groups, before, during, and after the intervention period. The basic design of this classification is based on the ABAB structure, where "A" refers to the baseline phase and "B" indicates the intervention phase.In the first baseline phase (A), participants do not receive any yoga exercises for a duration of 18 days. On the first, fourth, eighth, twelfth, and sixteenth days, predetermined tests are conducted and recorded. Generally, these tests are repeated five times during this phase.In the first intervention phase (B), participants engage in 10 yoga training sessions over a period of 24 days, with each session lasting 90 minutes. Tests are administered and recorded every four days. Typically, these tests are repeated six times during this phase.In the second baseline phase (A), participants do not receive any yoga exercises for a duration of 18 days. Tests are conducted and recorded every four days. Generally, these tests are repeated four times during this phase.In the second intervention phase (B), participants participate in 10 yoga training sessions over a period of 24 days, with each session lasting 90 minutes. Tests are administered and recorded every four days. Typically, these tests are repeated six times during this phase.Throughout all stages (a total of 21 tests), measurements are repeatedly taken and recorded. The data obtained from the conducted tests are transformed into graphical representations, and visual analysis is employed to examine the data within and between phases.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Association of Special Diseases of Borujerd
Full name of responsible person
Fatemeh Yarahmadi
Street address
Islamic Azad Univercity of Borujerd, Standard St, Andishe 8th phase
City
Borujerd
Province
Lorestan
Postal code
0000000000
Phone
+98 66 0000 0000
Email
name@domain.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ali Ariapour
Street address
Imam Khomeini University Complex; Yadgar Imam St; Nawab Sq
City
Borujerd
Province
Lorestan
Postal code
6915136111
Phone
+98 66 4251 8000
Email
name@domain.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
The financial resources of the research were provided privately.
Proportion provided by this source
100
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Faezeh AliBakhshi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Sport Medicine
Street address
No. 36, Pirasteh Alley, North Modares St , Nakhi Crossroad
City
Borujerd
Province
Lorestan
Postal code
6919753935
Phone
+98 66 4244 4225
Fax
Email
faezehalibakhshi97@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Faezeh Alibakhshi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Sport Medicine
Street address
No. 36, Pirasteh Alley, North Modares St , Nakhi Crossroad
City
Borujerd
Province
Lorestan
Postal code
6919753935
Phone
+98 66 4244 4225
Email
faezehalibakhshi97@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Faezeh Alibakhshi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Sport Medicine
Street address
No. 36, Pirasteh Alley, North Modares St , Nakhi Crossroad
City
Borujerd
Province
Lorestan
Postal code
6919753935
Phone
+98 66 4244 4225
Email
faezehalibakhshi97@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
After removing confidential information, participants' data files can be made available to future researchers.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Researchers of scientific and academic institutions and related students
Under which criteria data/document could be used
Currently, no specific conditions have been determined.
From where data/document is obtainable
To access the data, refer to the email address below.
faezehalibakhshi97@gmail.com
What processes are involved for a request to access data/document
Currently, no specific conditions have been determined.If necessary, the researcher can contact the email address provided and the details of her/ him service will be provided