Determining the effectiveness of virtual group counseling based on health literacy on the empowerment and self-care of pregnant women
Design
The current study will be a controlled clinical trial on 84 pregnant women (42 women in each intervention and control groups). Eligible samples will be allocated to two intervention and control groups by random block method.
Settings and conduct
The research setting will include 6 comprehensive centers of urban-rural health services in Langrud city. At first, the researcher will refer to these centers and check all pregnant women according to the criteria for entering the study using the convenience sampling method. If eligible, the adult health literacy questionnaire will be completed after explaining the objectives and importance of the research and obtaining written informed consent from the samples. Women will be included in the study if they have a score of less than 66, and demographic-obstetrical, empowerment and self-care questionnaires will be completed by the participants.
Participants/Inclusion and exclusion criteria
woman with a low-risk pregnancy and a health literacy level score below 66
Intervention groups
The intervention group will received the virtual group counseling based on health literacy in general dimensions and a multi-dimensional strategy with the content of empowerment and self-care on the internet and using an audio-video platform during five regular 30-40 minute weekly sessions.
The control group will receive routine pregnancy care.
Main outcome variables
Empowerment and self-care of pregnant women
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221109056451N1
Registration date:2024-04-14, 1403/01/26
Registration timing:prospective
Last update:2024-04-14, 1403/01/26
Update count:0
Registration date
2024-04-14, 1403/01/26
Registrant information
Name
Fatemeh Bakouei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3232 2589
Email address
bakouei2004@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-20, 1403/02/01
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
Assessment the effectiveness of the virtual group counseling based on health literacy on empowerment and self-care of pregnant women
Public title
Investigating the effect of group counseling on empowerment and self-care of pregnant women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age 14-20 weeks
Willingness to participate in the study
Having a health literacy score of less than 66
Having at least middle school literacy
Having a smart mobile phone and the ability to communicate with social messengers and the Internet
Understanding and ability to speak Persian
Exclusion criteria:
Exposed to high-risk pregnancy conditions
Having a known chronic disease
Receiving formal empowerment and self-care training before entering the study
Mothers who educated in medical and paramedical fields
Dependence on substances according to the person's own statements
Having mental illnesses according to the person's own statements
Age
From 18 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible women will be allocated to one of the control and intervention groups using a random method with blocks of four in a one-to-one ratio, so that the researcher cannot predict which group the next person will be in. The random list will be prepared using Random Allocation Software.
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
Research Ethics Committees of Health Research Institute - Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Ganj Afroz Ave, Babol
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶۴۷۷۴۵
Approval date
2024-03-16, 1402/12/26
Ethics committee reference number
IR.MUBABOL.HRI.REC.1402.202
Health conditions studied
1
Description of health condition studied
Empowerment and self-care of pregnant women
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Empowerment
Timepoint
Before and one month after the intervention
Method of measurement
Pregnant women empowerment questionnaire
2
Description
Self care
Timepoint
Before and one month after the intervention
Method of measurement
Pregnancy self-care questionnaire
Secondary outcomes
1
Description
Health literacy
Timepoint
Before and one month after the intervention
Method of measurement
Adult Health Literacy Standard Questionnaire HELIA-33
Intervention groups
1
Description
Intervention group: empowerment and self-care counseling based on health literacy: the content of empowerment and self-care counseling based on health literacy will be prepared based on authentic scientic texts and related articles based on the research objectives, and content validity will be approved by the professors of the research team as well as 3-5 colleagues outside the research team. Eligible pregnant women of 20-14 weeks will be included in the study. The first session for all pregnant women will start from 20-22 weeks and after that regular and weekly counseling sessions for 5 weeks online for 30-40 minutes a day and at a certain time in the form of groups (5-8 ) will be done. Group counseling will be done over the Internet and through a platform that can be easily installed on smartphones. Through the group created by the researcher in the Ita social messenger, the participants will receive the link to enter the meeting before the start of the meeting, and they will enter the meeting simply by clicking on the link sent and having access to the Internet. Audio and video group members will interact with each other and with the researcher (student).
Category
Behavior
2
Description
Control group: Routine pregnancy care: They will receive the usual trainings during pregnancy (trainings that are given face-to-face by health care providers during pregnancy care to mothers).
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive urban-rural health service centers of Langrod city
Full name of responsible person
Fatemeh Bakouei
Street address
Ganj Afrooz
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 911 315 8440
Email
bakouei2004@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Vice President of Research and Technology: Dr. Mehdi Rajab Nia
Street address
Ganj Afrooz
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 911 315 8440
Email
bakouei2004@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Fatemeh Bakouei
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Ganj Afrooz
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶۴۷۷۴۵
Phone
+98 11 3232 2589
Email
bakouei2004@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Fatemeh Bakouei
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Ganj Afrooz
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶۴۷۷۴۵
Phone
+98 11 3232 2589
Email
bakouei2004@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Fatemeh Bakouei
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Babol University of Medical Sciences, Ganj Afrooz St., Babol, Mazandaran
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶۴۷۷۴۵
Phone
+98 11 3232 2589
Email
bakouei2004@yahoo.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
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
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available