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The effect of motivational interviewing throughout pregnancy on birth preference: a randomized controlled trial

Protocol summary

Study aim
The present study aims to investigate the effect of motivational interviews conducted during pregnancy on birth preference.
Design
The design is of a randomized controlled experimental type. Obstetrics polyclinics of a university and a state hospital, Çanakkale, Turkey. A total of 100 pregnant women, 50 in the experimental group and 50 in the control group, were included in the study. Three motivational interviews, initiated during pregnancy (Week 26-28) and continued in the postnatal period, were conducted with the experimental group. Nutrition training was provided for the control group during pregnancy.
Settings and conduct
The study population consisted of all pregnant women who referred to obstetrics polyclinics of Çanakkale Onsekiz Mart University Healthcare, Practice and Research Hospital and Çanakkale State Hospital during 01 March 2019-02 March 2020.
Participants/Inclusion and exclusion criteria
Inclusion Criteria - Primigravid status (women experiencing their 1st pregnancy), - Married (civil marriage) pregnant women in gestational week 26-28, - 50% of the experimental group and the control group consisted of pregnant women from rural areas, - Pregnant women no physical disability, - No diagnosis of a psychiatric condition (verbally confirmed), - Subjects willing to participate in the study, - Those without pregnancy considered ‘risky’, - Pregnant women without planned cesarean section Exclusion criteria - know how to read and write - not be a foreign national
Intervention groups
Motivational interviews (face to face)
Main outcome variables
Mother's perception of self-efficacy regarding labor, fear of childbirth, intention, significance, confidence-efficacy parameters of motivational interviews, birth preference

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220509054795N1
Registration date: 2022-05-12, 1401/02/22
Registration timing: retrospective

Last update: 2022-05-12, 1401/02/22
Update count: 0
Registration date
2022-05-12, 1401/02/22
Registrant information
Name
Eda CANGÖL
Name of organization / entity
Çanakkale Onsekiz Mart Üniversitesi
Country
Turkey
Phone
+90 286 218 13 97
Email address
edacangol@comu.edu.tr
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-01, 1397/12/10
Expected recruitment end date
2020-03-02, 1398/12/12
Actual recruitment start date
2019-03-01, 1397/12/10
Actual recruitment end date
2020-03-02, 1398/12/12
Trial completion date
empty
Scientific title
The effect of motivational interviewing throughout pregnancy on birth preference: a randomized controlled trial
Public title
The effect of motivational interviewing birth preference
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
- Primigravid status (women experiencing their 1st pregnancy) - Married (civil marriage) pregnant women in gestational week 26-28, - 50% of the experimental group and the control group consisted of pregnant women from rural areas, - Pregnant women no physical disability, - No diagnosis of a psychiatric condition (verbally confirmed), - Subjects willing to participate in the study, - Those without pregnancy considered ‘risky’, - Pregnant women without planned cesarean section
Exclusion criteria:
know how to read and write not be a foreign national
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Actual sample size reached: 63
Randomization (investigator's opinion)
Randomized
Randomization description
A total of 100 pregnant women who met the inclusion criteria, i.e. those who referred to obstetrics polyclinics of Çanakkale Onsekiz Mart University Healthcare, Practice and Research Hospital and Çanakkale State Hospital during 01 March 2019-02 March 2020. Were assigned to the experimental group or the control group (50 women in each group) by randomization using the random sampling method. Randomization was performed by assigning numbers to the pregnant women according to their order of presentation using a table of random numbers to assign the first number in the experimental group and the second number in the control group.
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
Approval was obtained from Uşak University Ethics Committee
Street address
1 September Campus/Usak University
City
Uşak
Postal code
64000
Approval date
2016-04-06, 1395/01/18
Ethics committee reference number
local; ethics registration code: 97627247-050.99-11461

Health conditions studied

1

Description of health condition studied
None
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Mother's perception of self-efficacy regarding labor
Timepoint
Pretest and posttest
Method of measurement
Self-Sufficiency in Labor Scale-Short Form

2

Description
The intent of motivational Interview, significance, confidence-efficacy parameters
Timepoint
Pretest and post-test
Method of measurement
MI Rating Scale

3

Description
fear of childbirth
Timepoint
Pretest and post-test
Method of measurement
Delivery Expectancy/Experience Questionnaire (W-DEQ), version A

Secondary outcomes

1

Description
Mother's perception of self-efficacy regarding labor
Timepoint
after 1 month
Method of measurement
Self-Sufficiency in Labor Scale-Short Form

2

Description
The intent of motivational Interview, significance, confidence-efficacy parameters
Timepoint
after 1 month
Method of measurement
MI Rating Scale

3

Description
fear of childbirth
Timepoint
after 1 month
Method of measurement
Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ), version B

4

Description
Mode of Delivery
Timepoint
after 1 month
Method of measurement
Postnatal Maternal Information Form

Intervention groups

1

Description
To support vaginal delivery, three motivational interviews, initiated during pregnancy (Week 26-28) and continued in the postnatal period, were conducted with the experimental group. Motivational interviews in the third trimester were preferred as this is a period close to delivery. The interviews were conducted individually since the motivational interviewing technique is an individual-based method.Timeline of Motivational Interviews (MIs) was as follows; The first interview: Antenatal week 26-28 The second interview: Antenatal week 32-34 The third interview: Postnatal day 1
Category
Behavior

2

Description
Since it would not be ethically appropriate to apply no intervention in the control group, individual nutrition training was provided during pregnancy in this group. The content of this training included managing nutrition during pregnancy, important nutrients during pregnancy, weight gain during pregnancy, and nutritional recommendations in physiological changes during pregnancy.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Faculty of Health Sciences, Çanakkale Onsekiz Mart University, Turkey
Full name of responsible person
Eda Cangöl
Street address
Çanakkale Onsekiz Mart University Terzioğlu Campus, Faculty of Health Sciences
City
Çanakkale
Postal code
17000
Phone
+90 286 218 13 97
Email
edacangol@comu.edu.tr

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Koç University
Full name of responsible person
Ayşe Ferda Ocakçı
Street address
Topkapı
City
İstanbul
Postal code
34010
Phone
+90 212 311 26 40
Email
sanerc@ku.edu.tr
Grant name
Grant code / Reference number
2019.1.6
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Koç University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Çanakkale Onsekiz Mart University
Full name of responsible person
Eda Cangöl
Position
Assistant Prof., PhD
Latest degree
Ph.D.
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Çanakkale Onsekiz Mart University Terzioğlu Campus, Faculty of Health Sciences
City
Çanakkale
Province
Çanakkale
Postal code
17000
Phone
+90 286 218 13 97
Email
edacangol@comu.edu.tr

Person responsible for scientific inquiries

Contact
Name of organization / entity
Çanakkale Onsekiz Mart University
Full name of responsible person
Eda Cangöl
Position
Assistant Prof., PhD
Latest degree
Ph.D.
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Çanakkale Onsekiz Mart University Terzioğlu Campus, Faculty of Health Sciences
City
Çanakkale
Province
Çanakkale
Postal code
17000
Phone
+90 286 218 13 97
Email
edacangol@comu.edu.tr

Person responsible for updating data

Contact
Name of organization / entity
Çanakkale Onsekiz Mart University
Full name of responsible person
Eda Cangöl
Position
Assistant Prof
Latest degree
Ph.D.
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Çanakkale Onsekiz Mart University Terzioğlu Campus, Faculty of Health Sciences
City
Çanakkale
Province
Çanakkale
Postal code
17000
Phone
+90 286 218 13 97
Email
edacangol@comu.edu.tr

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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