Protocol summary

Study aim
Determining the effect of online yoga on anxiety, stress and quality of life of patients after coronary artery transplant surgery.
Design
Selection of people available and then by simple randomization in two control and intervention groups, two groups are matched in terms of age, gender and number of grafts, one strain is blind.
Settings and conduct
Yoga is online. The beginning of each session is related to good human qualities such as kindness and we want until the next session to avoid the trait of anger and so that they can give kindness and smile to themselves and those around them. They will be relaxed and then they will perform abdominal and chest breathing exercises and then three sitting asana movements including Paschi Motan Asana, Bhojanga Asana, Navasana and two standing asana movements including Otan Asana and Ardhachandrasan will be performed in patients. Relaxation in soft light for 15 minutes will be the good end of the session.
Participants/Inclusion and exclusion criteria
Entry criteria: less than 75 years old, ability to communicate in Farsi, ability to read and write, patient with a smartphone and the ability to use social networks, permission to participate in an online yoga class according to the opinion of a cardiologist, ability to do yoga Exit criteria: if the person is not able to do yoga for any reason, not filling out the questionnaire completely (10%), not attending more than 3 sessions
Intervention groups
People in the control group receive routine rehabilitation interventions, but in the intervention group, in addition to that, yoga exercises under the supervision of a yoga specialist and a cardiologist, twice a week and each time for one hour during two months, online in the networks will be held virtually.
Main outcome variables
Effects on anxiety and stress and quality of life of patients after coronary artery transplant surgery

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180913041030N2
Registration date: 2022-11-22, 1401/09/01
Registration timing: prospective

Last update: 2022-11-22, 1401/09/01
Update count: 0
Registration date
2022-11-22, 1401/09/01
Registrant information
Name
Roghayeh Mehdipour Rabori
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5220
Email address
r_mehdipour@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-20, 1401/09/29
Expected recruitment end date
2023-04-18, 1402/01/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of online yoga on anxiety, stress, and quality of life of patients after coronary artery bypass graft surgery
Public title
The effect of online yoga on anxiety, stress, and quality of life of patients after coronary artery bypass graft surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
less than 75 years old Establish communication in persian language Ability to read and write The patient has a smartphone and has the ability to use social networks. She/he is allowed to participate in the online yoga class according to the cardiologist's opinion. Have the ability to do yoga.
Exclusion criteria:
If a person is not able to do yoga for any reason (such as musculoskeletal disease, history of mental illness, personal problems, severe chest pain during yoga exercises, new cardiac arrhythmia). incomplete filling of the questionnaire (10%) Not attending more than 3 online yoga sessions
Age
To 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 82
Randomization (investigator's opinion)
Randomized
Randomization description
The samples will be selected between the patients according to the study entry criteria, then they will be placed in two equal groups (Control and intervention) by simple random. In fact, the names of the patients already exist, and the researchers put the names in a container and draw one among them by chance, and one is placed in the control group and the other in the intervention group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The analyst does not know who is in the control group and who is in the intervention group.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Kerman University of Medical Sciences
Street address
کرمان, ابتدای محور هفت باغ علوی, پردیس دانشگاه علوم پزشکی کرمان
City
کرمان
Province
Kerman
Postal code
7616913555
Approval date
2022-11-07, 1401/08/16
Ethics committee reference number
IR.KMU.REC.1401.317

Health conditions studied

1

Description of health condition studied
Patients after coronary artery bypass surgery
ICD-10 code
Z50.0
ICD-10 code description
Z50.0

Primary outcomes

1

Description
Anxiety score in DASS21 questionnaire
Timepoint
The beginning of the study (before the start of the intervention) and two months after the start of yoga
Method of measurement
Anxiety, stress and depression questionnaire DASS21

2

Description
Stress score in DASS 21 questionnaire
Timepoint
At the beginning of the study (before the start of the intervention) and two months after the start of the intervention (yoga)
Method of measurement
Anxiety, stress and depression questionnaire DASS21

3

Description
Quality of life score in MacNew questionnaire
Timepoint
At the beginning of the study (before the start of the intervention) and two months after the start of the intervention (yoga)
Method of measurement
MacNew Quality of Life Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients for whom yoga intervention is performed after coronary artery bypass surgery. Yoga under the supervision of a yoga specialist and the supervision and approval of a cardiologist, twice a week and each time for one hour during two months, will be held online on virtual networks (the first session in person)
Category
Rehabilitation

2

Description
Control group: Patients for whom yoga intervention is not performed after coronary artery transplant surgery. People in the control group receive routine interventions.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
shafa hospital
Full name of responsible person
Roghayeh Mehdipour Rabori
Street address
Kerman medical university
City
kerman
Province
Kerman
Postal code
7616913555
Phone
+98 913 143 3430
Email
rm41321@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mohamad shabani
Street address
Haftbagh Alavi
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3226 3815
Email
shabani@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
personal
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
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Roghayeh Mehdipour Rabori
Position
Associated professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5000
Email
rm41321@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Roghayeh Mehdipour Rabori
Position
Associated professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kerman Medical University, Haft bagh Alavi
City
Kerman
Province
Kerman
Postal code
761691355
Phone
+98 34 3132 5000
Email
rm41321@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Roghayeh Mehdipour Rabori
Position
Associated professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kerman Medical University, Haft bagh Alavi
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5000
Email
rm41321@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Relied on secrecy
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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