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Comparison of effectiveness of midwifery counseling based on Solution-focused approaches and routine prenatal cares on preferred normal vaginal delivery in women with elective cesarean section based on Extended Parallel Process Model (EPPM)

Protocol summary

Summary
This study aims to investigate the effectiveness of midwifery counseling based on solution-focused approaches on preferred normal vaginal delivery based on Extended Parallel Process Model (EPPM). Design: A randomized multicenter non-blinded controlled trial. Setting and conduct: The overall aim and setting of the study are explained for eligible people. Samples will be allocated to intervention and control groups with the block size of 4 and informed consents are completed. The control group will receive routine cares. The intervention group will participate in solution-focused sessions as well as receiving routine cares. Sessions are held weekly. Inclusion criteria: nulliparous women, age of 18 to 35 years, gestational age of 22 to 30 weeks at the starting point of the study, healthy and normal fetus in first trimester ultrasound scans (no fetal anomalies, normal placental position, normal cervix length), no evident and diagnosed prohibition of vaginal delivery at the time of sampling, having at least primary education, singleton pregnancy, having normal body mass index, negative history of psychotherapy or mental disease, no cigarette, opioid, and alcohol addiction, having single partner , negative history of repetitive abortion and infertility, preferred cesarean delivery at the starting point of the study. Exclusion criteria: absence more than two sessions, moving home and no access to pregnant mothers and termination of pregnancy for any reason before completion of counseling sessions, any indication of cesarean delivery.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016042425480N1
Registration date: 2016-05-28, 1395/03/08
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-05-28, 1395/03/08
Registrant information
Name
Masoumeh Sharifzadeh
Name of organization / entity
Shahroud University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 4466 6828
Email address
sharifzade@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research; Shahroud University of Medical Sciences
Expected recruitment start date
2016-05-21, 1395/03/01
Expected recruitment end date
2016-10-22, 1395/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effectiveness of midwifery counseling based on Solution-focused approaches and routine prenatal cares on preferred normal vaginal delivery in women with elective cesarean section based on Extended Parallel Process Model (EPPM)
Public title
The effectiveness of midwifery counseling on preferred normal vaginal delivery
Purpose
Prevention
Inclusion/Exclusion criteria
This study aims to investigate the effectiveness of midwifery counseling based on solution-focused approaches on preferred normal vaginal delivery based on Extended Parallel Process Model (EPPM). Design: A randomized multicenter non-blinded controlled trial. Setting and conduct: The overall aim and setting of the study are explained for eligible people. Samples will be allocated to intervention and control groups with the block size of 4 and informed consents are completed. The control group will receive routine cares. The intervention group will participate in solution-focused sessions as well as receiving routine cares. Sessions are held weekly. Inclusion criteria: nulliparous women, age of 18 to 35 years, gestational age of 22 to 30 weeks at the starting point of the study, healthy and normal fetus in first trimester ultrasound scans (no fetal anomalies, normal placental position, normal cervix length), no evident and diagnosed prohibition of vaginal delivery at the time of sampling, having at least primary education, singleton pregnancy, having normal body mass index, negative history of psychotherapy or mental disease, no cigarette, opioid, and alcohol addiction, having single partner , negative history of repetitive abortion and infertility, preferred cesarean delivery at the starting point of the study. Exclusion criteria: absence more than two sessions, moving home and no access to pregnant mothers and termination of pregnancy for any reason before completion of counseling sessions, any indication of cesarean delivery.
Age
From 18 years old to 35 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
Ethics committee of Shahroud University of Medical Sciences
Street address
Central building of Shahroud University of Medical Sciences, Tir Square,Shahroud. shahroud Semnan Iran, Islamic Republic Of 3614773955
City
Shahroud
Postal code
3614773955
Approval date
2016-02-25, 1394/12/06
Ethics committee reference number
IR.SHMU.REC.1394.193

Health conditions studied

1

Description of health condition studied
cesarean delivery without indication
ICD-10 code
082
ICD-10 code description
cesarean delivery without indication

Primary outcomes

1

Description
Self-efficacy for preferred delivery method
Timepoint
Before intervention and a week later
Method of measurement
Standard questionnaire of Extended Parallel Process Model (EPPM)

2

Description
Behavioral intention
Timepoint
Before intervention and a week later
Method of measurement
Standard questionnaire of Extended Parallel Process Model (EPPM)

Secondary outcomes

1

Description
Delivery Expectancy/Experience
Timepoint
Before intervention and a week later
Method of measurement
Standard questionnaire of Wijma Delivery Expectancy/Experience(W-DEQ)

Intervention groups

1

Description
The intervention group will participate in solution-focused sessions(6sessions,45-60 minutes) as well as receiving routine cares.
Category
Behavior

2

Description
The control group will receive routine prenatal cares.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Urban Health Center of Sabzevar University of Medical Sciences
Full name of responsible person
Masoumeh Sharifzadeh
Street address
Central building of Shahroud University of Medical Sciences, Tir Square,Shahroud.
City
Shahroud

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research; Shahroud University of Medical Sciences
Full name of responsible person
Dr Mohammadhasan Emamian
Street address
Central building of Shahroud University of Medical Sciences, Tir Square,Shahroud.
City
Shahroud
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; 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
Masoumeh Sharifzadeh
Position
Master science of student counseling midwiferys
Other areas of specialty/work
Street address
Central building ofShahroud University of Medical Sciences,Hafte Tir Square, Shahroud
City
Shahroud
Postal code
3614773955
Phone
+98 23 3239 4499
Fax
Email
msharifzade@yahoo.com sharifzade@shmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahroud university of medical sciences
Full name of responsible person
Zahra Motaghi
Position
Faculty member
Other areas of specialty/work
Street address
Central building ofShahroud University of Medical Sciences,Hafte Tir Square, Shahroud
City
Shahroud
Postal code
3614773955
Phone
+98 23 3239 5054
Fax
Email
zhrmotaghi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahroud university of medical sciences
Full name of responsible person
Masoumeh Sharifzadeh
Position
Master science of student counseling midwifery
Other areas of specialty/work
Street address
Central building ofShahroud University of Medical Sciences,Hafte Tir Square, Shahroud.
City
Shahroud
Postal code
3614773955
Phone
+98 23 3239 5054
Fax
Email
sharifzade@shmu.ac.irmsharifzade@yahoo.com
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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