Determine the impact of supportive counseling on decision self-efficacy and intention to Vaginal Birth after Caesarean in prior cesarean section mothers
Design
Clinical trials with control group and parallel groups without blindness ; and Randomized.
Settings and conduct
Initially, 2 comprehensive health centers are randomly selected from Mashhad comprehensive health centers (1,2,3,4, and 5). From each center, 2covered base are selected.then, one 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 one centers and one group from one envelopes are selected simultaneously. Sampling will be done at each base in an accessible manner.
Participants/Inclusion and exclusion criteria
1-desire to participate in study 2-.Low birth fear score less than 85 from Vijima questionnaire version A, which indicates no clinical fear 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 . Non-entry terms: indication of cesarean section, medical or obstetric disease, non-transverse cesarean section,Failure to attend at least one counseling session, failure to take the test after research,Failure to receive channel content and pamphlets.
Intervention groups
'intervention group" receives two Individual of supportive counseling sessions for 45 minutes and resive the pamphlet and the link of the messenger channel . Control group: receives routine counseling about vaginal birth after cesarean by midwives at health centers.
Main outcome variables
Decision self-efficacy and intention to Vaginal birth after cesarean
General information
Reason for update
Acronym
VBAC
IRCT registration information
IRCT registration number:IRCT20200614047768N1
Registration date:2020-06-21, 1399/04/01
Registration timing:prospective
Last update:2020-06-21, 1399/04/01
Update count:0
Registration date
2020-06-21, 1399/04/01
Registrant information
Name
Roghayeh Pakdaman
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 1511
Email address
pakdamanr971@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-20, 1399/04/30
Expected recruitment end date
2020-11-20, 1399/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of supportive counseling on decision self-efficacy and intention to Vaginal Birth after Caesarean in prior cesarean section mothers
Public title
The impact of counseling on decision self-efficacy and intention
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Iranian and resident of Mashhad
At least have the ability to read and write
The interval between pregnancy and previous delivery is greater than 6 months
Childbirth fear score less than 85 from Vijima questionnaire version A, which indicates no clinical fearand Single-pregnancy
A live embryo and a cephalic display Amniotic fluid and placental placement are normal based on pregnancy ultra sonography in trimester 2
. The gestational age based on the LMP or the first trimester ultrasound is of 28-30 weeks
BMI 19/8-29/9
History of once prior cesarean section
Do not have a history of infertility
Do not have a history of mental and medical illness
No complication of midwifery(Preeclampsia, diabetes, etc)
Not having a medical cause for cesarean section
No history of any surgery on the uterus other than a transverse incision below the previous cesarean section
Exclusion criteria:
Not participating to attend at least one counseling session
Not participating to take the test after research
Indication of pregnancy termination before the end of the research period
Failure to receive channel content and pamphlets
Occurrence of medical disease and obstetric complication during research
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation of groups will be such that the names of the databases that are randomly selected and the names of the groups are written on separate papers and placed in two separate envelopes.Then the name of a database and a group of direct envelopes are selected simultaneously. Thus, one base from the center will be allocated to the intervention group and one base from each center will be allocated to the control group, and a total of two bases will be allocated to the control group and two bases to the intervention group. Then, sampling will be done inside each center.
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
2020-06-15, 1399/03/26
Ethics committee reference number
IR.MUMS.NURSE.REC.1399.018
Health conditions studied
1
Description of health condition studied
vaginal birth after cesarean
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The intent Vaginal birth after cesarean
Timepoint
At the beginning of the study and 4 week after the intervention.
Method of measurement
Intent selection choose the type of delivery checklist
2
Description
Decision self-efficacy
Timepoint
At the beginning of the study and 4 week after the intervention.
Method of measurement
Decision self-efficacy questionnaire
3
Description
Decision Conflict
Timepoint
At the beginning of the study and 4 week after the intervention.
Method of measurement
Decision Conflict Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
"Intervention Group" Consulting package based on the supportive counseling approach includes: 1- Two individual supportive counseling sessions for each session of 45 minutes and in the middle of the week and in person and face to face 2- Pamphlet and link of the messenger channel.Content of counseling sessions based on supportive counseling steps includes the first session: explanation (right to choose the type of delivery, natural childbirth mechanism, recurrent cesarean complications), reassurance (benefits of natural childbirth for mother and baby, comparison of benefits and losses of natural childbirth after cesarean section, amount The success of natural childbirth after cesarean section), the content of the second session: guidance (methods of awakening in Libra, relaxation techniques in Liber, different positions in Libra and childbirth, mobile support, helping to remove barriers to selection from his point of view), encouragement (experience Her mothers have had a back-to-back presentation of her statistics, her success rate, and leave for emotional discharge (listening to clients talk about their feelings, beliefs, experiences, and expectations about childbirth).At the end of the first session, the delivery of the pamphlet and the link of the messenger channel will be provided (channel content includes: showing cesarean section and natural childbirth animation (taken from the educational contents of the Ministry of Health and uploading the audio file of the interview with mothers who have had a successful back)
Category
Behavior
2
Description
Control group: The "control group" receives routine counseling about vaginal birth after cesarean by midwives at health centers.