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Assessment of the effect of group consultation on pregnant women's knowledge, attitude and decision making about type of delivery

Protocol summary

Summary
The aim of this study is to determine the effect of consultation on pregnant women's knowledge, attitude and decision making about kind of delivery. This experimental study will be done on referred pregnant women to health centers in Sari. Nulliparous mothers between 24 to 32 weeks of pregnancy who tend to cesarean or are undecided about delivery mode, without indication for cesarean and do not participate in the child birth preparation classes will be recruited. Firstly, sample size was calculated 28 women in each group with a 95% confidence interval and power of 80%. It was finally calculated 35 women for each group, by considering 20 percent of drop out. After taking informed consent, participants will be divided into the intervention and control groups through simple random allocation using table of random numbers. In the intervention group, consultation with cognitive approach will be performed in 3 groups consist of 11-12 women over 8 sessions, 90 minutes for each session. The control group will just receive mothers' routine educations about delivery modes according to Ministry of Health and Education of Iran protocols for midwifery services and maternal cares. Demographic questionnaire and questionnaire of knowledge, attitude and decision for delivery mode will be completed in the onset of study and 4 weeks after intervention and education. One point will be given to each correct answer for knowledge questions. Scoring of attitude questions will be done according to a Likert 5 point scale. Knowledge and attitude, as the primary outcomes, and decision making about delivery mood, as the second outcome, will be compared between the groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201608032792N2
Registration date: 2016-09-04, 1395/06/14
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-09-04, 1395/06/14
Registrant information
Name
Marjan Ahmadshirvani
Name of organization / entity
Mazandaran University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1226 7345
Email address
mashirvani@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences
Expected recruitment start date
2016-07-19, 1395/04/29
Expected recruitment end date
2016-09-16, 1395/06/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the effect of group consultation on pregnant women's knowledge, attitude and decision making about type of delivery
Public title
The effect of consultation on pregnant women's knowledge, attitude and decision about type of delivery
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: Nulliparous pregnant women between 24 and 32 weeks; at least high school education; plaaned pregnancy; no history of infertility ; no limitation for natural birth; tend to cesarean or undecided about delivery mode; not participation in preparation before child birth classes and no indication for cesarean such as multiple gestation; pelvic contraction; abnormal amniotic fluid according to ultrasonography report; fetal distress and macrosomia. Exclusion criteria: preterm labor; intra uterine growth restriction; rapture of amniotic member; obstetrics and non-obstetrics causes of cesarean; given up to participate in the study and decision to participate in child birth preparation classes.
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 70
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
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Vice Chancellor for Research and Technology of Mazandaran University of Medical Sciences, Moalem sq.
City
Sari
Postal code
Approval date
2016-06-13, 1395/03/24
Ethics committee reference number
IR.MAZUMS.REC.95.1952

Health conditions studied

1

Description of health condition studied
Decision making
ICD-10 code
Z53.1, Z53
ICD-10 code description
Procedure not carried out because of patient's decision for reasons of belief and group pressure, Procedure not carried out because of patient's decision for other and unspecified reasons

Primary outcomes

1

Description
mothers' knowledge about delivery mode
Timepoint
Secondary outcome timepoint In the onset of study and 4 weeks after interventionand 4 weeks after intervention
Method of measurement
Knowledge questionnaire

2

Description
mothers' attitude about delivery mode
Timepoint
In the onset of study and and 4 weeks after intervention
Method of measurement
attitude questionnaire

Secondary outcomes

1

Description
mothers' decision making about delivery mode
Timepoint
In the onset of study and and 4 weeks after intervention
Method of measurement
decision assessment questionnaire

Intervention groups

1

Description
Group consultation
Category
Behavior

2

Description
Pregnant mothers' routine educations about delivery modes according to Ministry of Health and Education of Iran protocols for midwifery services and maternal cares
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Health Centers of Sari
Full name of responsible person
Nastaran Bagherian
Street address
Nursing and Midwifery School, Vesal St.
City
Sari

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology of Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Ahmad Ali Enayati
Street address
Moalem sq., Vice Chancellor for Research and Technology of Mazandaran University of Medical Sciences
City
Sari
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 and Technology of Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Marjan Ahmad Shirvani
Position
Faculty Member
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Vesal st.
City
Sari
Postal code
Phone
+98 11 3336 7342
Fax
Email
MAShirvani@mazums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Marjan Ahmad Shirvani
Position
Master of Science
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Vesal st.
City
Sari
Postal code
Phone
+98 11 3336 7342
Fax
Email
MAShirvani@mazums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Marjan Ahmad Shirvani
Position
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Vesal st.
City
Sari
Postal code
Phone
+98 11 3336 7342
Fax
Email
MAShirvani@mazums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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