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Investigating the effect of Implementing a Maternal role development care program based on Mercer's theory on the maternal identity of primiparous mothers: an experimental study

Protocol summary

Study aim
Determining the impact of the maternal role development care program based on Mercer's theory on the maternal identity of primiparous women Determining and comparing the average indicators of baby's physical growth in intervention and control groups
Design
An experimental study, educational intervention, post-test only with a control group. 70 primiparous with the expectation of 25% loss will be entered into the study gradually and using the block randomization method, block size of 4 or 6, they will equally be divided into 2 groups.
Settings and conduct
the study is based in clinic of Al-Zahra Hospital in Rasht. The care sessions will be carried out at 30-34 weeks, 35-40 weeks of pregnancy and after delivery during discharge. The baby's physical growth indicators will be recorded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: willingness to participate, age over 18 years, primiparous, gestational age 30-34 weeks, singleton pregnancy, living with a spouse, at least primary education, access to the Internet and a smartphone. Non-entry criteria: history of infertility, medical problems, severe obstetric problems during pregnancy
Intervention groups
The mothers of the intervention group receive the care program in 3 sessions. The topics include social support, postpartum maternal care, infant care, breastfeeding, warning signs of health disorders in mothers and infants, mother-infant bonding, and maternal self-efficacy. Mothers in the control group receive routine care. The mothers of both groups will be followed up until 2 months after delivery.
Main outcome variables
The demographic variables questionnaire at the entering; Maternal identity questionnaire and the 2nd part of demographic variables through epoll 2 months after delivery; The baby's physical growth indicators through the records and 2 months after delivery through the records of health centers (SIB).

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160102025809N2
Registration date: 2024-06-19, 1403/03/30
Registration timing: prospective

Last update: 2024-06-19, 1403/03/30
Update count: 0
Registration date
2024-06-19, 1403/03/30
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3333 8512
Email address
zahra_taheri@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-21, 1403/04/01
Expected recruitment end date
2024-09-22, 1403/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of Implementing a Maternal role development care program based on Mercer's theory on the maternal identity of primiparous mothers: an experimental study
Public title
Investigating the effect of Implementing a Maternal role development care program based on Mercer's theory on the maternal identity of primiparous mothers: an experimental study
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study age over 18 years primiparity gestational age 30 to 34 weeks singleton pregnancy living with a spouse at least primary literacy access to the Internet and a smartphone
Exclusion criteria:
History of infertility medical problems severe obstetric problems during pregnancy (uncontrolled diabetes, pre-eclampsia, placenta previa, placental abruption, intrauterine growth restriction)
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 25
Randomization (investigator's opinion)
Randomized
Randomization description
All eligible primiparous women will be divided equally (1:1 ratio) into test and control groups using the block randomization method with a block size of 4 or 6. The Sealed Envelope Ltd online randomization service will be used to generate the randomization list. Allocation concealment was implemented by means of a randomization list generated by a third party independent of the research team. This person prepares a list of codes corresponding to block sizes 4 and 6 and puts each code in sealed envelopes. The envelopes are then numbered sequentially and held until allocated to participants. At each stage of participant recruitment, the next envelope is opened and allocation is made based on the information in the envelope. This procedure ensures that neither the researchers nor the participants will be aware of the group allocation ahead of time. They will be informed about this only after allocation.
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
Ethics Committee in Guilan University of Medical Sciences
Street address
Deputy of Research and Technology ,Old Building, School of Health, Shahid Siadati Avenue, Namjoo St.Guilan,Rasht,Iran
City
Rasht
Province
Guilan
Postal code
4144666949
Approval date
2024-05-29, 1403/03/09
Ethics committee reference number
IR.GUMS.REC.1403.093

Health conditions studied

1

Description of health condition studied
pregnancy
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Maternal identity score in maternal identity scale
Timepoint
2 months after delivery
Method of measurement
Maternal identity scale, which consists of 3 fields and 24 statements. The field of attachment to the baby has 6 statements, the field of role adequacy has 8 statements, and the field of satisfaction with the role has 10 statements. This scale is based on a 5-point Likert scale (I completely disagree = 1, I disagree = 2, I have no opinion = 3, I agree = 4, I completely agree = 5). The scoring of this tool ranges from a minimum of 24 to a maximum of 120, and the higher the score, the higher the level of achieving maternal identity.

Secondary outcomes

1

Description
baby's height
Timepoint
Immediately after childbirth and 2 months after childbirth
Method of measurement
Immediately after childbirth through the information recorded in the files and 2 months after childbirth through the information recorded in the systems of health centers (SIB system) in centimeters

2

Description
baby's head circumference
Timepoint
Immediately after childbirth and 2 months after childbirth
Method of measurement
Immediately after childbirth through the information recorded in the files and 2 months after childbirth through the information recorded in the systems of health centers (SIB system) in centimeters

3

Description
baby's weight
Timepoint
Immediately after childbirth and 2 months after childbirth
Method of measurement
Immediately after childbirth through the information recorded in the files and 2 months after childbirth through the information recorded in the systems of health centers (SIB system) in grams

Intervention groups

1

Description
Intervention group: Mercer's maternal role development theory has 4 stages. The first stage before childbirth, when a person seeks information from others and imagines herself as a mother. The second stage, which is up to 2 weeks after birth, and the person learns from others and repeats their behavior and acquires competence through practice. The third stage, which is 2 weeks to 4 months after childbirth, and the person structures the role of mother based on past experiences and future goals, and creates her own unique style of motherhood. The fourth stage, which is 4 months after childbirth, integrates motherhood into her system, internalizes the role and sees herself as a worthy mother. At this stage, a person achieves the identity of a mother. In stages 1 and 2 of this theory, the nurse's role is significant, so care interventions will be implemented in these two stages. That is, before delivery and during the first 2 weeks after delivery. According to Mercer, all these stages overlap with each other so that a mother may achieve maternal identity even in 1 month after giving birth. Therefore, we intend to measure the attainment of maternal identity 2 months after delivery. In the test group, mothers' needs are checked first in the anticipatory phase. The care program will be planned in 3 sessions. According to Mercer's theory, the topics of the care program will generally include social support, postpartum maternal care, infant care, breastfeeding, warning signs of health disorders in mothers and infants, mother-infant bonding, and maternal self-efficacy. Mothers learn care in 3 sessions. So that the first session will be held at 30-34 weeks of pregnancy, the second session at 35-40 weeks of pregnancy at Al-Zahra Clinic, and the third session will be held at the hospital after delivery. Care content is provided to mothers using educational booklets. Also, the educational content file will be placed on the mother's smartphone by the researcher in the first session and the researcher will ensure that the file is applicable for all people. Also, a log book is considered to record the activities of using care, content and training for each person, in which the researcher records this information in each session. The researcher is informed about the date of birth of the mothers by phone call. and answers their questions using periodic phone calls. The third meeting is held in the hospital and before discharge, where they receive the care plan in the form of a demonstration and lecture. In the show, babies are used to implement the trainings and mothers are asked to carry out the trainings on their babies and the researcher supervises them. Mothers will be followed up with regular phone calls up to 2 months after delivery, and if needed, they can contact the researcher to answer their questions.
Category
N/A

2

Description
Control group: In this group, the participants receive routine pregnancy care that is implemented in Al-Zahra educational-therapeutic center. Routine care includes 8 sessions class on childbirth preparation, meditation and breastfeeding, which are optional and not all mothers participate in these classes. Also, the nurse responsible for breastfeeding is present in the hospital and helps mothers to breastfeed if needed. The researcher will be informed about the date of birth of the mothers of the control group by phone. The phone number of the researcher will be provided to the mothers to answer their questions and any problems. In order to comply with the ethical principles, at the end of the intervention, all educational content will be available to all people in the control group.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Al-Zahra Medical-Educational Center
Full name of responsible person
Fatemeh Hosseinzadeh
Street address
Al-Zahra Medical Educational Center, Namjoo St.
City
Rasht
Province
Guilan
Postal code
41446-54829
Phone
+98 13 3336 9324
Email
azzahra@gums.ac.ir
Web page address
https://azzahra.gums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Ramiar Farzan
Street address
In front of 17 Shahrivar Hospital, Siadati St., Namjoo St.
City
Rasht
Province
Guilan
Postal code
41446-66949
Phone
+98 13 3333 5821
Email
research@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht University of Medical Sciences
Proportion provided by this source
50
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
Rasht University of Medical Sciences
Full name of responsible person
zahra taheri ezbarami
Position
faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery School of Shahid Dr. Beheshti, Hamidyan Shahrak, Shahid Dr. Beheshti Ave., Rasht, Guilan, IRAN
City
Rasht
Province
Guilan
Postal code
41469-39841
Phone
+98 13 3355 5058
Fax
+98 13 3355 0097
Email
zahra_taheri@gums.ac.ir
Web page address
http://www.gums.ac.ir/nmr

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
zahra taheri ezbarami
Position
faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery School of Shahid Dr. Beheshti, Hamidyan Shahrak, Shahid Dr. Beheshti Ave., Rasht, Guilan, IRAN
City
Rasht
Province
Guilan
Postal code
41469-39841
Phone
+98 13 3355 5058
Fax
+98 13 3355 0097
Email
zahra_taheri@gums.ac.ir
Web page address
http://www.gums.ac.ir/nmr

Person responsible for updating data

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
zahra taheri ezbarami
Position
faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery School of Shahid Dr. Beheshti, Hamidyan Shahrak, Shahid Dr. Beheshti Ave., Rasht, Guilan, IRAN
City
Rasht
Province
Guilan
Postal code
41469-39841
Phone
+98 13 3355 5058
Fax
+98 13 3355 0097
Email
zahra_taheri@gums.ac.ir
Web page address
http://www.gums.ac.ir/nmr

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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
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