Investigating the effect of pregnancy yoga Exercises on breastfeeding self-efficacy in primiparous mothers referring to selected comprehensive health centers
Comparison of the mean score of breastfeeding self-efficacy on the first day and after the intervention of one, two and four, 8 weeks and 6 months after delivery
Design
The clinical trial has a control group which is initially stratified according to the available method and then randomly stratified according to the education level of the mothers in two groups. The number of samples in each group is 45. The sealed envelope technique is used for randomization.
Settings and conduct
The environment is selected comprehensive health centers
in the Isfahan. This study was not blinded. The researcher will do yoga exercises in groups in 12 sessions in these centers and the questionnaires in six stages after delivery (the first week after delivery and 2 ,4 ,8 weeks and six months after delivery) will be completed.
Participants/Inclusion and exclusion criteria
Mothers who are literate.
Mothers who had a normal body mass index at the beginning of pregnancy.
Mothers who do not have a history of systemic diseases (diabetes/hypertensive/intrauterine death/multiples) etc. during their pregnancy.
Mothers who do not have medical contraindications to exercise and perform yoga stretching exercises
Mother's willingness to breastfeed after delivery
Mothers who do not have breast diseases and anomalies
Mothers who have not been subjected to domestic violence
Mothers who have participated in childbirth preparation classes.
Mothers who have no history of participating in yoga classes and professional sports (regular daily walking, swimming, etc.)
Intervention groups
Yoga sessions will be held as a group at the venue of birth preparation classes in selected centers, twice a week and for one hour each time from the 34th week of pregnancy to 8 weeks after delivery (12 sessions).
Investigating the effect of pregnancy yoga Exercises on breastfeeding self-efficacy in primiparous mothers referring to selected comprehensive health centers
Public title
pregnancy yoga Exercises and breastfeeding self-efficacy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Mothers who sign the informed consent form.
Mothers who are literate.
Mothers who had a normal body mass index at the beginning of pregnancy.
Mother's willingness to breastfeed after delivery
Mothers who have no history of systemic diseases during their pregnancy (diabetes/hypertensive/intrauterine death/multiples) etc.
Mothers who do not have medical contraindications to exercise and do yoga stretches.
Mothers who do not have Breast anomalies.
Mothers who have no history of infertility (primary, secondary).
Mothers who have not been subjected to domestic violence
Mothers who have participated in childbirth preparation classes.
Mothers who have no history of participating in yoga classes and professional sports (regular daily walking, swimming, etc.)
Exclusion criteria:
The impossibility of natural childbirth
Mother's physical inability to do exercises
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Stratified random assignment based on education level into two groups
The selection of samples will be based on the available method at first, and then they will be randomly divided into intervention and control groups and matched according to their education level.
In order to assign samples in each group, they were asked to choose one of the sealed envelopes. Envelope number one is assigned to the control group and number 2 to the intervention group. Then, based on the education level of the mothers, sampling will continue until the level of education in the two groups is equal.
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
Nursing, Rehabilitation and Management schools- Isfahan University of medical Sciences
Street address
Hezar JeribAve, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2023-12-19, 1402/09/28
Ethics committee reference number
IR.MUI.NUREMA.REC.1402.151
Health conditions studied
1
Description of health condition studied
breastfeeding self-efficacy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
breastfeeding self-efficacy score
Timepoint
The first day after delivery, week 1, 2, 4, 8, the sixth month after the intervention
Method of measurement
Dennis and Fox BSES breastfeeding self-efficacy questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Yoga sessions will be held in groups in selected centers, twice a week and for one hour each time from the 34th week of pregnancy to 8 weeks after delivery (12 sessions).
Category
Behavior
2
Description
Control group: Samples in this group only receive routine pregnancy care in comprehensive health centers
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Hamzeh Comprehensive Health Center
Full name of responsible person
Pirhadi Masoume
Street address
6th Ave, Amirieh town
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7592
Email
pirhadi@nm.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Pirhadi Masoume
Street address
Faculty of Nursing and Midwifery - Isfahan University of Medical Sciences - Hazar Jerib St
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7592
Email
pirhadi@nm.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
1
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
Esfahan University of Medical Sciences
Full name of responsible person
Pirhadi Masoume
Position
Academic member, Instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery - Isfahan University of Medical Sciences - Hazar Jarib St
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7592
Email
pirhadi@nm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Pirhadi Masoume
Position
Academic member, Instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery - Isfahan University of Medical Sciences - Hazar Jarib St
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7592
Email
pirhadi@nm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Pirhadi Masoume
Position
Academic member, Instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery - Isfahan University of Medical Sciences - Hazar Jarib St
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7592
Email
pirhadi@nm.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available