The effect of cognitive behavioral group counseling on self efficacy of pregnant women to choose normal vaginal delivery compared with routine pregnancy care program.
Objectives: This study aimed to determine the effect of cognitive behavioral group counseling approach on self-efficacy in pregnant women for choosing of natural childbirth. Design: single blinded trial. Setting and conduct: in this study, 60 women that will be candidate for physiological delivery, after a filling a informed consent, allocate in two groups according to a permuted block randomization method. Major inclusion and exclusion criteria: women who have not had the experience of labor and delivery, and are candidate for physiological childbirth. Intervention: group counseling with cognitive-behavioral approach, for three weeks. Every session will be implemented with 6 till 10 subjects weekly. Intervention will conducted with participation of a physiatrist, psychologist and a consultant midwife. The control group will receive the routine prenatal care in health centers. Main outcome measures variables: a standard self-efficacy questionnaire were designed with the researcher and were validated in another study. This questionnaire will complete by both groups, before and after of intervention, again in the last month of pregnancy (39 weeks of pregnancy). We will expect, after the counseling sessions, pregnant women be able to choose the type of delivery with their own informed choices.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015063022983N1
Registration date:2016-02-03, 1394/11/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-02-03, 1394/11/14
Registrant information
Name
Farideh Ghasemi
Name of organization / entity
Shahroud University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 0428
Email address
f.ghasemi@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shahroud University of Medical Sciences
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2015-10-22, 1394/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of cognitive behavioral group counseling on self efficacy of pregnant women to choose normal vaginal delivery compared with routine pregnancy care program.
Public title
The effect of counseling on self efficacy of pregnant women to choose normal vaginal delivery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Pregnant women without experience of a childbirth, 15 untill 49 years olds, no history of infertility, candidates for physiological delivery, womens with no experience of any underlying physical illness or complications in pregnancy, no history of mental illness in pregnancy,women with at least primary education level, Pregnant women in their third trimester of pregnancy, urban pregnant women, be not a participants of childbirth preparation classes, without any embryonic disease and had not decided for type of delivery.
Exclusion criteria: pregnant women who have experienced childbirth, women who are not candidates for physiological delivery.
Age
From 15 years old to 49 years old
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
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
Shahroud University of Medical Sciences
Street address
Central Building of Shahroud University of Medical Sciences, Hafte-Tir Square
City
Shahroud
Postal code
3614773955
Approval date
2015-06-20, 1394/03/30
Ethics committee reference number
IR.SHMU.REC.1394.41
Health conditions studied
1
Description of health condition studied
Selfefficacy
ICD-10 code
094099
ICD-10 code description
094099
Primary outcomes
1
Description
Self efficacy of selecting vaginal delivery
Timepoint
Before intervention, after intervention,39 weak of gestational age
Method of measurement
Self efficacy questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralmomenin Hospital
Full name of responsible person
Ghasemi farideh
Street address
Zanjan Province , Khodabandeh city , Amiralmomenin Hospital
City
Khodabandeh
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Ghasemi farideh
Street address
No. 3 , Alley haghighat , Imam Khomeini Ave
City
Khodabandeh
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Farideh Ghasemi
Position
MSc Midwifery counselling
Other areas of specialty/work
Street address
Central Building University of Shahroud Medical Sciences, Hafte-Tir Square
City
Shahroud
Postal code
3614773955
Phone
+98 23 3239 0428
Fax
+98 23 3239 4088
Email
farideghasemi92@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Farideh Ghasemi
Position
MSc Midwifery counselling
Other areas of specialty/work
Street address
Central Building University of Shahroud Medical Sciences, Hafte-Tir Square
City
Shahroud
Postal code
3614773955
Phone
+98 23 3239 0428
Fax
+98 32394088
Email
farideghasemi92@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Farideh Ghasemi
Position
MSc Midwifery
Other areas of specialty/work
Street address
City
Shahrood
Postal code
3614773955
Phone
+98 23 3239 0428
Fax
+98 23 3239 4088
Email
farideghasemi92@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)