Comparison between the effect of Doing Yoga exercises and Mindfulness-Based Stress Reduction (MBSR) counseling on the Index and consequences of pregnancy in pregnant women after the twentieth week
- Comparison of Demographic variables in three groups of Yoga, Mindfulness-based stress reduction counseling and Control group before the intervention
- Comparison of the mean score of pregnancy outcomes in three groups of Yoga, Mindfulness-based stress reduction counseling and Control group before the intervention
- Comparison of the mean score of pregnancy outcomes in three groups of Yoga, Mindfulness-based stress reduction counseling and Control group after the intervention
- Comparison of the mean score of pregnancy outcomes in the Yoga group before and after the intervention
- Comparison of the mean score of pregnancy outcomes in Mindfulness-based stress reduction counseling group before and after the intervention
Design
Clinical trial will be with three groups (Two intervention groups and one control group).150 pregnant women, will be selected by block randomization and 50 people will be placed in each group.
Settings and conduct
The randomized clinical trial will be performed on 150 pregnant women referring to health centers in Kerman in 2022. They will be divided into 3 groups of 50 people.( Yoga, Mindfulness-based stress reduction counseling, Control). Data will be collected before the intervention, after the intervention and two weeks after the intervention, and after delivery through the pregnancy outcomes questionnaire.
Participants/Inclusion and exclusion criteria
Pregnant women after the twentieth week referred to Kerman health centers,2022
Intervention groups
In the yoga intervention group, Yoga exercises will be performed virtually for three weeks.(Three sessions per week).
In the Mindfulness-based stress reduction counseling intervention group, the counseling will be performed virtually for three weeks.(Two sessions per week)
In the control group, they will receive routine care.
Main outcome variables
Consequences of pregnancy such as Preeclampsia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170504033812N3
Registration date:2021-12-26, 1400/10/05
Registration timing:prospective
Last update:2021-12-26, 1400/10/05
Update count:0
Registration date
2021-12-26, 1400/10/05
Registrant information
Name
Shahrzad Zolala
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 23871
Email address
zolala@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-01, 1400/10/11
Expected recruitment end date
2023-01-01, 1401/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between the effect of Doing Yoga exercises and Mindfulness-Based Stress Reduction (MBSR) counseling on the Index and consequences of pregnancy in pregnant women after the twentieth week
Public title
Comparison between the effect of Doing Yoga exercises and Mindfulness-Based Stress Reduction (MBSR) counseling on the Index and consequences of pregnancy
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Being pregnant
Having complete physical and mental health (absence of gastrointestinal, heart or other underlying diseases)
Literacy to the extent of reading and writing
Having a single, normal, live, uncomplicated pregnancy and maintaining it until the end of the study
Women in the age range of 18 to 35 years
Willingness to participate in the study
Exclusion criteria:
Loss of pregnancy
Reluctance to continue participating in the study
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
150 pregnant women will be selected by Permuted block randomization. There will be 50 woman in each group. Eventually, there will be 45 pregnant women in each group considering the probability of a sample loss.
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
ethical committee of Kerman University of Medical Sciences
Before the intervention, immediately after the intervention, two weeks after the intervention and after delivery
Method of measurement
Pregnancy Outcome Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Women will do yoga exercises including movements such as preliminary relaxation of the body and breathing techniques, safe asana in the supine position, deep relaxation with guided imagery, pranayama and meditation using mental imagery and gentle song for three weeks (three sessions per week). Yoga exercises will be done virtually by presenting a video by the specialist ( having a valid certificate).
Category
Prevention
2
Description
Intervention group: Counseling with a mindfulness-based stress reduction approach in women will be conducted for three weeks (two sessions per week) in the form of six virtual two-hour sessions. Mindfulness exercises will be performed virtually by a trained and certified person.
Category
Prevention
3
Description
Control group: Routine interventions
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipour hospital
Full name of responsible person
Haniye Soltaninegad
Street address
Afzalipour Educational and Medical Center,Imam Khomeini Highway, next to Shahid Bahonar University
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 3132 8000
Email
afzalipour@kmu.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Kerman University of Medical Sciences, Deputy of research and technology
Street address
Ebn-e-Sina St.,Jahad Blvd., Kernan,Iran
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3855
Email
induniv@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Shahrzad Zolala
Position
aStudent Research Committee, Razi faculty of Nursing and Midwifery, Kerman University of Medical Sci
Latest degree
Master
Other areas of specialty/work
Midwifery
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 5219
Email
zolala@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Shahrzad Zolala
Position
Student Research Committee, Razi faculty of Nursing and Midwifery, Kerman University of Medical Scie
Latest degree
Master
Other areas of specialty/work
Midwifery
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 5219
Email
shahrzad.zolala@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Shahrzad Zolala
Position
Student Research Committee, Razi faculty of Nursing and Midwifery, Kerman University of Medical Scie
Latest degree
Master
Other areas of specialty/work
Midwifery
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 5219
Email
zolala@sbmu.ac.ir
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
Undecided - It is not yet known if there will be 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
Part of the data, such as information about the main outcome can be shared.
When the data will become available and for how long
Start the access period at 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
In case of citation to the article
From where data/document is obtainable
shahrzad.zolala@gmail.com
What processes are involved for a request to access data/document
The files will be sent within one month after reading the email.
Email: shahrzad,zolala@gmail.com