Determine the impact of individual counseling through Fogg model on the intention to choose Vaginal birth after cesarean in pregnant mothers in Mashhad Health Centers
Design
Clinical trials with control group and parallel groups without blindness ; and Randomized.
Settings and conduct
At first, five centers of health centers in Mashhad, Center No 3 and 1 were randomly selected. From each center, 4 bases with random numbers are selected.In order to prevent interaction and dissemination of information in two groups, From any center two bases and totally 4 bases will be allocated to each group randomly assigned. The method of random assignment is that the names of the bases and the names of the groups will be written on separate papers and placed in two separate envelopes. Then the names of two centers and a one group of two envelopes are selected simultaneously. Two bases from each center were assigned to the intervention group and two bases from each center to the control group. Sampling at each center is done in an accessible manner..
Participants/Inclusion and exclusion criteria
1-desire to participate in study 2- Age between 18 and 35 years. 3- Gestational age between 28 weeks and 30 weeks. 4- low-risk singleton pregnancies and is showing head. 5- Having a history of previous cesarean section. 6. Do not have a history of infertility. 7- Not having a medical cause for cesarean section, such as a transverse position, previous uterine surgery, etc. Non-entry terms: indication of cesarean section, medical or obstetric disease, non-transverse cesarean section
Intervention groups
Intervention group: three Individual counseling sessions for 45-60 minutes based on the Fogg model structure. Control group: Routine care of childbirth classes
Main outcome variables
intention to choose Vaginal birth after cesarean
General information
Reason for update
Acronym
VBAC
IRCT registration information
IRCT registration number:IRCT20200105046014N1
Registration date:2020-02-22, 1398/12/03
Registration timing:prospective
Last update:2020-02-22, 1398/12/03
Update count:0
Registration date
2020-02-22, 1398/12/03
Registrant information
Name
Somayeh Attarian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3606 7374
Email address
attarians971@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-01, 1398/12/11
Expected recruitment end date
2020-07-01, 1399/04/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of individual counseling through Fogg model on the intention to choose vaginal birth after cesarean in pregnant mothers
Public title
The effect of individual counseling on the intention to choose
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Iranian and resident of Mashhad
At least have the ability to read and write
Aged 18-35 years old
Single-pregnancy, A live embryo and a cephalic display
Amniotic fluid and placental placement are normal based on pregnancy ultra sonography
The interval between pregnancy and previous delivery is greater than 6 months.
The gestational age based on the LMP or the first trimester ultrasound is of 28-30 weeks.
History of once prior cesarean section
Do not have a history of infertility
Not having a medical cause for cesarean section, such as a transverse position, previous uterine surgery, etc.
Exclusion criteria:
indication of cesarean section.
Have a history of infertility.
Embryo abnormalities are contraindicated in normal delivery.
Have a medical or obstetric illness.
Non-transverse cesarean section.
Have a mental illness.
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Multi-stage sampling will be performed. The sampling frame is Mashhad comprehensive health centers. Initially, 2 comprehensive health centers are randomly selected from Mashhad comprehensive health centers (1,2,3,4, and 5). From each center, 4 covered base are selected according to the number of clients and appropriate locations for consultation. In order to prevent interaction and dissemination of information in two groups, two centers and totally 4 bases with random allocation are assigned to each group. The method of random assignment would be to have the name of the bases and the names of the groups written on separate papers and put in two separate envelopes. Then the names of two centers and one group from two envelopes are selected simultaneously. Sampling will be done at each base in an accessible manner.
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
Mashhad University of Medical Sciences and Health Services
Street address
Khorasan Razavi - Mashhad-Ave. University- Facing Khayyayan University 18- Mashhad University of Medical Sciences- Vice-President of Research and Technology University
City
Mashhad
Province
Razavi Khorasan
Postal code
9188667656
Approval date
2019-12-30, 1398/10/09
Ethics committee reference number
IR.MUMS.NURSE.REC.1398.081
Health conditions studied
1
Description of health condition studied
Vaginal birth after cesarean delivery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The intent to choose Vaginal birth after cesarean
Timepoint
At the beginning of the study and 2 and 4 week after the intervention.
Method of measurement
Intent selection choose the type of delivery checklist
2
Description
Fogg Model Structures (Motivation, Ability, Stimulus)
Timepoint
At the beginning of the study and 2 and 4 week after the intervention.
Method of measurement
Fogg Model Structures (Motivation, Ability, Stimulus) the researcher-made questionnaire
3
Description
Fear of delivery
Timepoint
At the beginning of the study and 2 and 4 week after the intervention.
Method of measurement
Vijma's fear of delivery Questionnaire; Version A
4
Description
Self-efficacy of delivery
Timepoint
At the beginning of the study and 2 and 4 week after the intervention.
Method of measurement
Maternal self-efficacy questionnaire
5
Description
Decision self-efficacy
Timepoint
At the beginning of the study and 2 and 4 week after the intervention.
Method of measurement
Decision self-efficacy questionnaire
6
Description
Decision Conflict
Timepoint
At the beginning of the study and 2 and 4 week after the intervention.
Method of measurement
Decision Conflict Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
intervention group:The 'intervention group" receives three Individual of Fogg model counseling sessions for 45-60 minutes and once every two weeks, based on a structure developed by the researcher and approved by a professor of psychology
Category
Behavior
2
Description
Control group: The "control group" receives routine counseling about vaginal birth after cesarean by midwives at health centers.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Center No. 1 of Mashhad
Full name of responsible person
Naser Amini
Street address
Health center No 1. After Vakilabad 66, Vakilabad Blvd, Mashhad, Razavi Khorasan, Iran