Design, implementation, and evaluation of a program to improve adolescent pregnancy health literacy through a social messenger and investigating its impact on self-care, maternal infant attachment and some pregnancy outcome.
Designing, implementing and evaluating the program to promote pregnancy health literacy in pregnant teenagers using a social messenger (ITA messenger) and investigating its effect on self-care, mother-baby attachment and some pregnancy outcomes.
Design
The study is a randomized controlled trial without blinding, with random allocation of 55 people in the intervention group and 55 people in the control group. The six-block method will be used for random allocation.
Settings and conduct
The present study will be conducted on the comprehensive health service center number four west of Ahvaz and the comprehensive health service center number one east of Ahvaz in the city of Ahvaz as a randomized clinical trial. After the samples are selected, the intervention group will receive the adolescent pregnancy health literacy promotion program obtained from the previous stages of the study in addition to routine prenatal care. and the control group will receive routine prenatal care.
Participants/Inclusion and exclusion criteria
Inclusion criteria
1) Ability to read and write in Farsi
2) Mothers under 19 years old
3) Being in the gestational age of 6 to 30 weeks of pregnancy
4) Access to the Internet and internal messengers
Non-entry criteria
1) Medical and background problems such as major or life-threatening disabilities
Intervention groups
The intervention group consists of teenage pregnant mothers who, in addition to receiving routine prenatal care, will receive the adolescent pregnancy health literacy promotion program based on internal messenger (ITA).
The control group received usual prenatal care.
Main outcome variables
maternal health literacy; maternal infant attachment; breastfeeding self-efficacy; Postpartum self-care
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230912059412N1
Registration date:2023-10-14, 1402/07/22
Registration timing:registered_while_recruiting
Last update:2023-10-14, 1402/07/22
Update count:0
Registration date
2023-10-14, 1402/07/22
Registrant information
Name
Mahsa Mirzababaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2227 7218
Email address
mirzababae.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-07, 1402/07/15
Expected recruitment end date
2024-10-06, 1403/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Design, implementation, and evaluation of a program to improve adolescent pregnancy health literacy through a social messenger and investigating its impact on self-care, maternal infant attachment and some pregnancy outcome.
Public title
Examining the impact of a program that promotes pregnancy health literacy on self-care, maternal infant attachment, and some pregnancy outcomes in pregnant teenagers.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
1) Ability to read and write in Farsi
2) Mothers under 19 years old
3) Being in the gestational age of 6 to 30 weeks of pregnancy
4) Access to the Internet and internal messengers
Exclusion criteria:
1) Medical and background problems such as major or life-threatening disabilities
Age
To 19 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
Six block method will be used for random allocation. For this purpose, all possible modes of placement of letters A (intervention) and B (non-intervention) will be considered in blocks of 6 with an allocation ratio of 1:1, and the number of required blocks will be determined based on the number of studied samples. Then, according to the number of required blocks and based on the table of random numbers, the blocks corresponding to each table number will be listed in order. Finally, when the samples are entered into the study, each person will acquire a certain letter according to the obtained order. are written, they are allocated in closed and non-transparent envelopes by a person outside the study who has no knowledge of the research objectives, and when choosing the envelopes, a person who has no knowledge of the research objectives is asked to choose an envelope slow After obtaining informed consent and randomly assigning people in each group, the educational program will be implemented by the researcher.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
By being present in the research environment and providing information about the pregnancy health literacy promotion program, the researcher invites pregnant adolescents who are willing to participate in the program and meet the criteria for entering the study, and by randomly assigning people to the intervention and non-intervention groups. intervention are divided. (There are 55 people in each group). For random allocation, the six block method will be used. For this purpose, all possible modes of placement of letters A (intervention) and B (non-intervention) will be considered in blocks of 6 with an allocation ratio of 1:1. It is a sequential stage. In the first stage, the researcher examines the health literacy needs of pregnant adolescents from the perspective of pregnant adolescents and key informants with a qualitative approach. In the second stage of the study, the researcher determines the priority needs of the adolescent pregnancy health literacy promotion program by using the nominal group technique and based on the opinions of key people, then in the third stage of the study of the promotion program Pregnancy health literacy will be designed using the ADDIE educational model. In the fourth stage, the researcher, by being present in the research environment and providing information about the educational program, invites pregnant teenagers who wish to participate in the program, and after obtaining written consent, the intervention group, which includes a total of 55 people, It divides 5 groups consisting of eleven pregnant teenagers and distributes the educational content through the internal messenger of ITA in an easy and understandable media format (Powerpoint with sound, video, poster, booklet, audio file) on a weekly basis within each group. In addition, the researcher will be responsible for supporting and answering possible questions. The non-intervention group also receives the usual pregnancy care and education. Then, in the fourth stage, the evaluation of pregnancy outcomes in the postpartum period (between 6 and 8 weeks after delivery) will be done in two intervention groups and non-intervention groups that received routine care and training.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
No 20, Gouy ababi Street, Zafar Ave
City
Tehran
Province
Tehran
Postal code
1916736513
Approval date
2023-08-22, 1402/05/31
Ethics committee reference number
IR.AJUMS.REC.1402.294
Health conditions studied
1
Description of health condition studied
Pregnancy health literacy in adolescent pregnancy
ICD-10 code
Z35.6
ICD-10 code description
Supervision of very young primigravida
Primary outcomes
1
Description
to improve adolescent pregnancy health literacy
Timepoint
Evaluation of maternal health literacy outcomes in the postpartum period (between 6 and 8 weeks after delivery) in intervention and non-intervention groups.
Method of measurement
Specific questionnaire for measuring maternal health literacy
Secondary outcomes
1
Description
maternal- infant attachment
Timepoint
Measurement of mother-infant attachment in the postpartum period (between 6 and 8 weeks after delivery) in two interventions and non-intervention groups.
Method of measurement
Condon and corkindale's postnatal attachment questionnaire
2
Description
Postpartum self-care
Timepoint
Measuring the performance of women in the field of postpartum self-care in the postpartum period (between 6 and 8 weeks after delivery) in two interventions and non-intervention groups.
Method of measurement
Questionnaire on women's performance in the field of self-care after childbirth
3
Description
Breastfeeding self-efficacy
Timepoint
Measurement of breastfeeding self-efficacy in the postpartum period (between 6 and 8 weeks after delivery) in two interventions and non-intervention groups.
Method of measurement
Dennis Short Breastfeeding Self-Efficacy Questionnaire (2003)
Intervention groups
1
Description
The intervention group is pregnant teenagers who meet the inclusion criteria. They will receive routine pregnancy care according to Iran's national guidelines. In addition, they will receive health literacy promotion program based on ITA's internal messenger in the manner described below. The educational content of the adolescent pregnancy health literacy promotion program will be designed based on first and second stages of the study. The researcher puts the educational content in an Comprehensible and easy way in the form of media (power point with sound, video, poster, booklet, audio file) through the internal messenger of ITA every week inside intervention group. Due to the unknown content of the program, the number of times and weeks that the program is uploaded in the internal messenger group is not known, It should be noted that the pregnancy health literacy promotion program for adolescents will be designed based on the needs of pregnant adolescents that identified through the first and second stages of the study.
Category
Behavior
2
Description
The control group is pregnant adolescents who meet the inclusion criteria. They will receive routine pregnancy care and training according to Iran's national guidelines.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive Health service center No 4. west of Ahvaz
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Mahsa Mirzababaei
Position
phD student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
No 20, Gouy abadi Street, Zafar Ave
City
Tehran
Province
Tehran
Postal code
1916736613
Phone
+98 21 2227 7218
Email
mirzababaei.m@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mojgan Javadnoori
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and Midwifery, Ahvaz University of Medical Sciences, Golestan Blvd, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135733337
Phone
+98 61 3373 8331
Fax
+98 61 3373 8333
Email
mojganjadnoori@gmail.com
Web page address
https://fnursing.ajums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mahsa Mirzababaei
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
No 20, Gouy Abadi St, Zafar Ave, Tehran
City
Tehran
Province
Tehran
Postal code
1916736513
Phone
+98 21 2227 7218
Email
mahsa.mirzababaei@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
All completed data and questionnaires will be provided to the Ahvaz University of Medical Sciences
When the data will become available and for how long
It will be possible to access the research documents six months after the statistical analysis and at the end of the fourth phase of the study
To whom data/document is available
The data will be available only for the use of researchers in academic institutions.
Under which criteria data/document could be used
This research will be done with the aim of improving pregnancy health literacy in pregnant teenagers, and the use of its documents is allowed only in this direction with the knowledge and permission of the responsible author.
From where data/document is obtainable
In order to receive the data, people can refer to the main execution of the project, Dr. Mojgan Javad Nouri, a member of the academic staff of Jundishapur University of Medical Sciences, Ahvaz.
What processes are involved for a request to access data/document
The applicant obtaining the necessary permission from the Jundishapur University of Medical Sciences and Vice The research and technology of this university can take action to receive documents.