Practical purposes:
If the effectiveness of yoga exercises in the postpartum period on functional status or reducing anxiety in nulliparous women in the postpartum period can be confirmed:
1- In order to improve the functional situation
2- Reduction of postpartum anxiety
To be used by midwives and relevant experts in intravenous and postpartum care.
Design
Randomized controlled clinical trial without blinding with control and intervention groups
Settings and conduct
This interventional study is a randomized controlled clinical trial in the postpartum period on nulliparous women referred to 2 Qazvin Health Centers affiliated to Qazvin University of Medical Sciences, with the aim of the effect of yoga exercises on functional status and anxiety. Will be done after delivery. The research environment in this study will be health centers in Qazvin. The research community will consist of primiparous women referring to health centers in Qazvin.
Participants/Inclusion and exclusion criteria
Inclusion criteria
Primiparous women
Age 18 to 40 years
Women with uncomplicated natural childbirth
No known mental illness and use of psychiatric drugs
Has a live baby and no abnormalities
Having physical health according to the mother
On the 10th to the 30th day of the mother's postpartum period
Not participating in other sports classes at the same time
Having and being able to use mobile phones and virtual networks to participate in virtual classes
Exclusion criteria
Up to two sessions of non-participation in yoga
Reluctance to continue cooperation in research
Intervention groups
Yoga exercises are taught regularly according to the protocol to the intervention group during 8 to 10 sessions and the control group receives routine care and after the study, they are given brochures and educational videos.
Main outcome variables
Yoga exercises can affect maternal and fetal outcomes.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210907052403N1
Registration date:2022-03-05, 1400/12/14
Registration timing:registered_while_recruiting
Last update:2022-03-05, 1400/12/14
Update count:0
Registration date
2022-03-05, 1400/12/14
Registrant information
Name
Samira Romina
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3289 7461
Email address
s.romina314@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-20, 1400/12/01
Expected recruitment end date
2022-04-25, 1401/02/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
THE EFFECT OF YOGA ON ANXIETY AND FUNCTIONAL STATUS OF NULLIPAROUS WOMEN IN THE POSTPARTUM PERIOD
Public title
The effect of yoga on anxiety and performance of women in the postpartum period
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Primiparous womenAge 18 to 40 years
Women with uncomplicated natural
childbirthNo known mental illness and use of psychiatric drugs
Has a live baby and no abnormalities
Having physical health according to the mother
On the 10th to the 30th day of the mother's postpartum period
Not participating in other sports classes at the same time
Having and being able to use mobile phones and virtual networks to participate in virtual classes
Exclusion criteria:
Up to two sessions of non-participation in yogaReluctance to continue cooperation in research
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Blocking will be used to balance the number of samples assigned to each of the study groups. The samples are divided into two groups of intervention and control by blocking randomization method and from each center, an equal number of people will be randomly divided into individual units in two groups A and B. The size of all blocks is equal and 36 people in the intervention group and 36 people in the control group will be randomly assigned to the random number table. In the randomization table, the samples are coded and the researcher randomly starts from a table point in the direction of the row or column to select the sample people from the table. The selection of the point can be done by closing the eyes and placing a finger or the tip of a pen on the table. Selects the same number of digits in the row or column direction and then controls the path numbers. The researcher will inevitably encounter two types of numbers, one of which is smaller than the number of the study population and the other is larger than the population. Which only considers and selects smaller numbers. The selected number is in fact the individual code of the community that is selected as a sample. This goes on until a small number can be selected based on the number of sample people. After completing the sample size, the sampling work is completed. Also, blinding is not used.
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
Management of Research and Technology of the University of Tehran
Street address
No. 1, Tehran University of Medical Sciences Headquarters Building, 6th Floor, Room 605, University Research and Technology Management, Keshavarz Blvd Intersection and Ghods St.,Tehran.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2022-02-01, 1400/11/12
Ethics committee reference number
IR.TUMS.FNM.REC.1400.189
Health conditions studied
1
Description of health condition studied
Anxiety and functional status by doing postpartum yoga movements
ICD-10 code
Y93.42
ICD-10 code description
Activity, yoga
Primary outcomes
1
Description
Functional status after delivery
Timepoint
Before and 14 days after the intervention
Method of measurement
Functional Status Questionnaire
2
Description
Anxiety
Timepoint
Before and 14 days after the intervention
Method of measurement
Beck Anxiety questionnaire
Secondary outcomes
1
Description
Social Support
Timepoint
Before and 14 days after the intervention
Method of measurement
Perceived Social Support Questionnaire
2
Description
Breastfeeding
Timepoint
Before and 14 days after the intervention
Method of measurement
Breastfeeding self-efficacy questionnaire
Intervention groups
1
Description
Intervention group: 36 people are in the Intervention group. In this study, yoga exercises to strengthen the minds and bodies of participants virtually in the postpartum period for 10 sessions, each session for 30 minutes for 5 weeks and 2 sessions per week by the researcher.In connection with the intervention group of yoga exercises in the form of online training by the researcher who has passed the postpartum yoga training course, will be uploaded on the site at the appointed time and the site link will be provided to the members of the intervention group. These tutorials can be applied online and offline for users. Skype software will be used to check the correct movement and the researcher will perform the movements visually for the mothers. After making sure that the movements are performed by the mother, the next movement will be uploaded at a specific time and the mother will be asked to Perform the movements calmly and accurately at the appointed time, then the researcher will call the mother to make sure that she performs those movements. Yoga exercises will be performed according to the protocol of Jayashari et al.The process of execution and the type of movements in each session are as follows: 1. Move the bridge2. Move the knee towards the chest3. Exercise one leg forward for the transverse abdominal muscles4- Exercise in hugging (working on the muscles of the upper back)5. Lateral extension exercise (longitudinal stretching of the spine muscles)6- Lying down (to strengthen the muscles of the back and shoulders)7. Strength recovery exercises in the legs and lower abdomen8- Exercise the abdominal and pelvic muscles while sitting on a chair9-Exercise the muscles of the upper back while lying down10-Exercise the abdominal and pelvic muscles while sitting on a chair11-Exercise lateral extension of longitudinal stretch of spinal muscles12-Simple screw drill13. Rotation and twisting in the hand14-Sitting deep screw15. Bend forward on the chairThe movements that will be done in each class are such that the beginning of each class is with a breathing meditation and relaxation, then the above exercises are performed, one repetition from each exercise in the first session and 2 repetitions in the second session, 3 repetitions in the third session. The fourth will be 4 repetitions and in sessions 5 to 10 of each movement will be 5 repetitions. At the end of the exercises, relaxation exercises will be performed. The order of these movements is the same in all sessions and the time spent in that movement (the amount of pause in each movement increases the difficulty of movement) gradually increases during the sessions.
Category
Lifestyle
2
Description
Control group: 36 people are in the control group. In the control group, except for routine actions, no intervention will be performed. Also, if you wish, postpartum yoga exercises will be provided to the control group after the intervention.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Bolandian Health Center in Qazvin
Full name of responsible person
Dr. Alireza Mehr Alian
Street address
above the canal, Shahid Babaei Street,Qazvin
City
Qazvin
Province
Qazvin
Postal code
3441633365
Phone
+98 28 3365 5035
Email
infobhc@qums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Afsane Safaii
Street address
School of Nursing and Midwifery, Tohid Square, Dr. Mirkhani St., (Eastern Nosrat ), Tehran.
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 4411
Email
Higher_education@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Zohre Khakbazan
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Tohid Square, Dr. Mirkhani St., (Eastern Nosrat), Tehran.
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4124
Email
khakbaza@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Samira Romina
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No8, saba6, 16th alley, sadoghi Ave.
City
Qazvin
Province
Qazvin
Postal code
3441653363
Phone
+98 28 3289 7461
Email
s.romina314@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Samira Romina
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No8, saba6, 16th alley, sadoghi Ave.
City
Abyek
Province
Qazvin
Postal code
3441653363
Phone
+98 28 3289 7461
Fax
Email
s.romina314@gmail.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