the training program on the mother and spouse and a keysupporter in the postpartum period
Design
The study is quasi-experimental00 mothers, spouses, and keysupport in the intervention group received training, and 100 in the control group received only postpartum outcome questionnaires.Health centers were randomly divided into intervention and control groups
Settings and conduct
The intervention was performed in Bojnourd Health Center and Hospital and included four training sessions for mothers, wives and key sponsors. The first session was held virtually during pregnancy and the third and fourth sessions were postpartum, but the second session was held in the hospital on the first day after delivery. A WhatsApp group in which all research units were members also answered the questions of the research samples 24 hours a day.
Participants/Inclusion and exclusion criteria
residents of Bojnourd and having literacy and first pregnancy. And any of the research units that wanted to leave the research during the study could be excluded from the study.
Intervention groups
The intervention group included education of mothers and wives and keysupporters who entered the study from the third trimester of pregnancy. The control group also completed only the questionnaires
Main outcome variables
The results of the study were Awareness in the third trimester and eight weeks after delivery the rate of breastfeeding in the first and second months after delivery and the level of satisfaction with postpartum care in the eighth week after delivery and the quality of life, postpartum depression and social support and the mother's performance in caring for herself and her baby. .
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180715040477N1
Registration date:2021-01-10, 1399/10/21
Registration timing:registered_while_recruiting
Last update:2021-01-10, 1399/10/21
Update count:0
Registration date
2021-01-10, 1399/10/21
Registrant information
Name
Sakineh Nazari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8865 5376
Email address
s4.nazari@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2021-01-20, 1399/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing Postpartum Care Needs: Designing, Implementing, and Evaluating a Need-Based Program in Bojnourd
Public title
Postpartum Care
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Be a resident of Bojnourd
Have the ability to read and write Persian
Be the first pregnancy.
Have no history of physical or mental illness
Mothers are 18 to 45 years old
Exclusion criteria:
Not wanting to continue research
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was done in such a way that health centers in Bojnourd city were first classified into two classes with economic benefits and low economic benefits, and then from each floor by drawing a health center as an intervention group and a health center to The title of the control group was selected
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
School of Pharmacy and Nursing & Midwifery- Shahid Beheshti University of Medical Sciences
Street address
Department of Reproductive Health and Midwifery (2th floor), School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Cross of Vali-Asr and Neiaiesh Highway, Opposite to Rajaee Heart Hospital, Tehran, Iran
City
tehran
Province
Tehran
Postal code
1996835119
Approval date
2019-06-10, 1398/03/20
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1398.089
Health conditions studied
1
Description of health condition studied
Postpartum care and examination
ICD-10 code
Z39
ICD-10 code description
Encounter for maternal postpartum care and examination
Primary outcomes
1
Description
Breastfeeding
Timepoint
The first and second after delivery
Method of measurement
Self made Questionnaire and checklist
2
Description
Postpartum satisfaction
Timepoint
Eight weeks after delivery
Method of measurement
Self made Questionnaire
3
Description
social support
Timepoint
two and Eight weeks after delivery
Method of measurement
Hapkinz Social Support questionnaire
4
Description
Quality of Life
Timepoint
two and Eight weeks after delivery
Method of measurement
Postpartum Quality of life questionnaire
5
Description
postpartum depretion
Timepoint
two and Eight weeks after delivery
Method of measurement
Edinburgh Postnatal Depression
6
Description
Function The mother takes care of the baby and herself
Timepoint
two and Eight weeks after delivery
Method of measurement
Self made Questionnaire
7
Description
Awareness of postpartum care
Timepoint
Third trimester in pregnancy and eight weeks after delivery
Method of measurement
Self made Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Considering that in the first phase of research in the fan panel of the nominal group of social support strategy for the able Motherhood in the postpartum period in the city of Bojnourd gained the most points. We considered the simultaneous education of mother and wife and a key supporter. Mothers were selected in the third trimester after delivery and an online training session was held for the mother and spouse and a key sponsor about the postpartum period. On the first day after delivery, a training session was held for the mother and wife and a key supporter in the hospital in person on maternal and infant care and breastfeeding. And two more virtual sessions for participants in the second week and the first month after delivery with a focus on mental health and physical activity of the mother and care of the baby. All research units in the WhatsApp Q&A group were also present to answer their questionsh
Category
Prevention
2
Description
Control group: 100 mothers, spouses and key sponsors whoWho do not receive any training completed the questionnaires in the third trimester of pregnancy, two weeks after delivery and eight weeks after delivery.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Bint Al-Huda Hospital in Bojnourd
Full name of responsible person
Sakineh Nazari
Street address
Department of Reproductive Health and Midwifery (2th floor), School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Cross of Vali-Asr and Neiaiesh Highway, Opposite to Rajaee Heart Hospital, Tehran, Iran
City
tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8865 5376
Email
s4.nazari@gmail.com
2
Recruitment center
Name of recruitment center
Bojnourd city health centers
Full name of responsible person
Sakineh Nazari
Street address
Department of Reproductive Health and Midwifery (2th floor), School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Cross of Vali-Asr and Neiaiesh Highway, Opposite to Rajaee Heart Hospital, Tehran, Iran
City
tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8865 5376
Email
s4.nazari@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Syed Ali Ziae
Street address
Department of Reproductive Health and Midwifery (2th floor), School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Cross of Vali-Asr and Neiaiesh Highway, Opposite to Rajaee Heart Hospital, Tehran, Iran
City
tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8865 5376
Email
s4.nazari@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sakineh Nazari
Position
Reproductive Health PhD Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Department of Reproductive Health and Midwifery (2th floor), School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Cross of Vali-Asr and Neiaiesh Highway, Opposite to Rajaee Heart Hospital, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8865 5376
Email
s4.nazari@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sakineh Nazari
Position
Reproductive Health PhD Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Department of Reproductive Health and Midwifery (2th floor), School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Cross of Vali-Asr and Neiaiesh Highway, Opposite to Rajaee Heart Hospital, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8865 5376
Email
s4.nazari@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sakineh Nazari
Position
Reproductive Health PhD Student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Department of Reproductive Health and Midwifery (2th floor), School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Cross of Vali-Asr and Neiaiesh Highway, Opposite to Rajaee Heart Hospital, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8865 5376
Email
s4.nazari@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
After the study, the main results of the research can be shared without mentioning the names of the research samples
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
The data will be available to researchers working in medical universities
Under which criteria data/document could be used
If data are used, the names of the authors of this research should also be mentioned
From where data/document is obtainable
Applicants can refer to the Vice Chancellor for Research of Shahid Beheshti University of Medical Sciences or send an email to s4.nazari@gmail.com.
What processes are involved for a request to access data/document
Applicants can request documents by writing to the Vice Chancellor for Research of Shahid Beheshti University of Medical Sciences or emailing s4.nazari@gmail.com six months after the publication of the articles