Determining the effect of hatha yoga on hope and fatigue of dialysis patients referring to Bou Ali Dialysis Center in Qazvin city
Design
Clinical trial with control group, simple randomization, sample size 62 people
Settings and conduct
The present study will be conducted as a clinical trial with a pre-test/post-test design with a control group. All the hemodialysis patients of Bu Ali sina Hospital Qazvin form the statistical population of the research. Sampling will be done in a simple random way.The names of the patients will be sent to the respected nephrology doctor to confirm their readiness to participate in yoga classes.
Participants/Inclusion and exclusion criteria
Inclusion criteria
At least six months have passed since their first hemodialysis appointment
Not participating in yoga classes since 6 months ago
Absence of medical prohibition of sports
Exclusion criteria
Any change in the general state of the patient's body during exercise so that he is not able to exercise.
Intervention groups
The course of the program is conducted by a specialist yoga trainer who has training experience in a specialized yoga club. The intervention program includes physical movements (50 minutes), meditation (15 minutes) and breathing and relaxation exercises (10 minutes). the participants in this group, 10 weeks of yoga, two sessions a week, where the beginning of the yoga intervention is 15 minutes per session and at the end of the study, it increases to 30 minutes per session.
Main outcome variables
Observing the significant effectiveness of yoga in improving the hopelessness of dialysis patients
Observing the significant effect of yoga on the fatigue of dialysis patients
In case of significant effectiveness, this method can be used as a complementary treatment for dialysis patients.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230926059516N1
Registration date:2024-02-16, 1402/11/27
Registration timing:retrospective
Last update:2024-02-16, 1402/11/27
Update count:0
Registration date
2024-02-16, 1402/11/27
Registrant information
Name
fatemeh Aghakhanbeigi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2212 5454
Email address
f.aghakhanbeigi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-23, 1402/08/01
Expected recruitment end date
2023-12-22, 1402/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Hatta yoga on hope and fatigue of hemodialysis patients referred to dialysis center
Public title
The effect of Hatta yoga on hope and fatigue of hemodialysis patients referred to dialysis center
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
At least six months have passed since their first hemodialysis appointment
Not participating in yoga classes since 6 months ago
To have the ability to train and perform Hatha Yoga exercises
Be able to do exercises
Absence of diagnosed cognitive and movement disorders
Absence of medical prohibition of sports
Exclusion criteria:
Any change in the general state of the patient's body during exercise (occurrence of acute problems) so that he is not able to exercise.
Withdrawal or unwillingness to do continuous exercises during the study.
Age
From 18 years old to 55 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization according to entry and exit criteria
Selection of the intervention and control group using a lottery, "yoga" and "non-yoga" were written on the paper and poured into a bag with the number of samples, then according to the list, the people of the group identify themselves.
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 Qazvin University of Medical Sciences
Street address
Qazvin univerdity medical of sience , Bahonar Blvd ,Qazvin
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Approval date
2023-05-08, 1402/02/18
Ethics committee reference number
IR.QUMS.REC.1402.028
Health conditions studied
1
Description of health condition studied
Hemodialysis patients
ICD-10 code
Z49.0
ICD-10 code description
Preparatory care for dialysis
Primary outcomes
1
Description
Hope rate in dialysis patients
Timepoint
Since starting hemodialysis
Method of measurement
Schneider hope questionnaire
2
Description
Fatigue in hemodialysis patients
Timepoint
Since starting hemodialysis
Method of measurement
Multidimensional Fatigue Inventory questionnaire
Secondary outcomes
1
Description
Hope rate after Hatha Yoga intervention
Timepoint
After 10 weeks
Method of measurement
Schneider hope questionnaire
2
Description
Fatigue rate after Hatha Yoga intervention
Timepoint
After 10 weeks
Method of measurement
Multidimensional Fatigue Inventory questionnaire
Intervention groups
1
Description
Intervention group: The intended intervention in this research includes the implementation of a type of Hatha Yoga program. The course of the program is conducted by a specialist yoga instructor who has training experience in a specialized yoga club. The intervention program includes physical movements (50 minutes), meditation (15 minutes) and breathing and relaxation exercises (10 minutes), which have been selected based on several studies that have used this type of yoga. Also, the participants in this group, 10 weeks of yoga, two sessions per week, the beginning of the yoga intervention is 15 minutes per session and at the end of the study, it increases to 30 minutes per session. Patients with vascular access in 1 arm only perform unilateral arm movements in the free arm and legs. Patients with vascular access in the chest move both arms and legs. The yoga intervention will consist of slow coordinated body movements with breathing within the patient's comfortable range of motion
Category
Lifestyle
2
Description
Control group: In the control group, the usual care of dialysis patients that all patients receive will be provided.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Boo Ali Dialysis Center
Full name of responsible person
Fatemeh Aghakhanbeigi
Street address
qazvin university medical of science School of Nursing and Midwifery, Blv Bahonar , Qazvin
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3333 6001
Email
f.aghakhanbeigi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Fatemeh Aghakhanbeigi
Street address
qazvin university medical of science, Bahonar Blv , Qazvin city
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3333 6001
Email
f.aghakhanbeigi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Fatemeh Aghakhanbeigi
Position
nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
qazvin university medical of science , Bahonar Blv , Qazvin city
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3333 6001
Email
f.aghakhanbeigi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Fatemeh Aghakhanbeigi
Position
nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Qazvin university medical of science, Bahonar blvd
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3333 6001
Email
f.aghakhanbeigi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Fatemeh Aghakhanbeigi
Position
nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Qazvin university medical of science , Bahonar blvd,
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3333 6001
Email
f.aghakhanbeigi@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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals
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 and people who are also engaged in the industry
Under which criteria data/document could be used
Researchers working in academic and scientific institutions
People who are also engaged in industry
In order to provide better services and care to dialysis patients
From where data/document is obtainable
f.aghakhanbeigi@gmail.com
What processes are involved for a request to access data/document
Send your request to email
State your resume and job status
Also state your purpose for using the data