Objective: this study performed to determine the effect of educational program on cesarean intention using "social cognitive theory and theory of planned behavior". Design: a randomized clinical trial on 146 pregnant women referred to three clinics of Kermanshah University of Medical Sciences (Rajai, farhangian and Hajdaee. Blinding isn't performed in this study. Women eligible were randomly based on time and place to visit allocated into two intervention and control groups. Each group consisted of 73 people. Inclusion criteria: gestational age 28 weeks or more, first pregnancy, lack of medical indications for cesarean delivery. Exclusion criteria: reluctant to participate in training sessions, Presence in the physiological childbirth classes, no more than one session of training sessions and the unavailability of pregnant women when completing the questionnaire. Intervention: in this study based on structure of social cognitive theory and theory of planned behavior, educational interventions in 4 sessions directly (in person) and indirect (non-verbal) is done for pregnant women and persons around them. Educational intervention lasts at least two weeks and it has Pre-test and post-test within a month after the intervention. main outcome measures: intention to perform cesarean section and subsequently reduce cesarean section in pregnant women.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015051822302N1
Registration date:2015-10-18, 1394/07/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-10-18, 1394/07/26
Registrant information
Name
Marzieh Kaboudi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3816 2559
Email address
fkaboudi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Kermanshah University of Medical Sciences
Expected recruitment start date
2015-05-03, 1394/02/13
Expected recruitment end date
2015-09-04, 1394/06/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of designed educational program on cesarean intention among nulliparous pregnant women
Public title
Assessment of designed educational program on cesarean intention among nulliparous pregnant women
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: aged between 18 to 35 years؛ gestational age 28 weeks and more؛ first pregnancy؛ do not have anxiety disorder and other mental disorders and do not have medical indication for cesarean delivery include multi gestation؛ Placenta previa؛ hysterotomy؛ breech presentation؛ preeclampsia.
Exclusion criteria:participate in the preparation childbirth class؛ lack of consent to participate in all training session.
Age
From 18 years old to 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
146
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomly assigned into two experimental and control groups in terms of location and time of the visit
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Shahid Beheshti Blvd, the number 2 Building
City
Kermanshah
Postal code
Iran
Approval date
2015-04-28, 1394/02/08
Ethics committee reference number
KUMS.REC.1394.7
Health conditions studied
1
Description of health condition studied
Cesarean
ICD-10 code
O82.8
ICD-10 code description
Other single delivery by caesarean section
Primary outcomes
1
Description
Cesarean intention
Timepoint
Before and 4 weeks after the end of intervention
Method of measurement
Questionnaire created by the resecher
2
Description
Attitude
Timepoint
Before and 4 weeks after the end of intervention
Method of measurement
Questionnaire created by the resercher
3
Description
Outcome expectations
Timepoint
Before and 4 weeks after the end of intervention
Method of measurement
Questionnaire created by the resecher
4
Description
Outcome expectancy
Timepoint
Before and 4 weeks after the end of intervention
Method of measurement
Questionnaire created by the resercher
5
Description
Subjective norms
Timepoint
Before and 4 weeks after the end of intervention
Method of measurement
Questionnaire created by the resercher
6
Description
Perceived behavioral control
Timepoint
Before and 4 weeks after the end of intervention
Method of measurement
Questionnaire created by the resercher
Secondary outcomes
empty
Intervention groups
1
Description
Questionnaire to assess attitudes, expectations, outcome, impact evaluation, subjective norms, perceived behavioral control and intention to perform caesarean sections that are assessed for Likert response. educational program is designed based on Some structures of Social cognitive theory and Theory of Planned Behavior include attitude, outcome expectations, Outcome expectancy, perceived behavioral control and Subjective norms for 4 sessions for 50 minutes with gestational age between 28 to 32 week. The questionnaire After 4 weeks of intervention in weeks 36 to 38 of pregnancy comes to action and total scores in both groups before and after training to assess and compare the impact of the training program.
Category
Behavior
2
Description
Questionnaire to assess attitudes, expectations, outcome, impact evaluation, subjective norms, perceived behavioral control and intention to perform caesarean sections that are assessed for Likert response in the control group with gestational age between 28 to 32 weeks and Specific training measures do not e in the control group and the group receiving only routine care during pregnancy. The questionnaire After 4 weeks of intervention in weeks 36 to 38 of pregnancy comes to action and total scores in both groups before and after training to assess and compare the impact of the training program.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rajai health center
Full name of responsible person
Parastoo Mohammadi
Street address
Dolatabad Boulevard
City
kermanshah
2
Recruitment center
Name of recruitment center
Hajdaee health center
Full name of responsible person
Parastoo Mohammadi
Street address
22 bahman, Golestan Blvd.
City
kermanshah
3
Recruitment center
Name of recruitment center
Farhangian health center
Full name of responsible person
Parastoo Mohammadi
Street address
Phase two Farhangian
City
kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research Kermanshah University of Medical Sciences
Full name of responsible person
Cyrus Hamzehi
Street address
Shahid Beheshti Blvd, Number 2 Building
City
kermanshah
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences, School of Nursing and Midwifery
Full name of responsible person
Marzieh Kaboudi
Position
Ph.D., Scientific Advisory Board
Other areas of specialty/work
Street address
Dolatabad, School of Nursing and Midwifery
City
kermanshah
Postal code
Phone
+98 83 3827 9394
Fax
Email
fkaboudi@kums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences, School of Nursing and Midwifery
Full name of responsible person
Marzieh Kaboudi
Position
P.h.D
Other areas of specialty/work
Street address
Dolatabad, School of Nursing and Midwifery
City
kermanshah
Postal code
Phone
+98 83 3827 9394
Fax
Email
fkaboudi@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences, School of Nursing and Midwifery
Full name of responsible person
Parastoo Mohammadi
Position
Master degree, Student
Other areas of specialty/work
Street address
Dolatabad, School of Nursing and Midwifery
City
kermanshah
Postal code
Phone
00
Fax
Email
pa.mohammadi@kums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)