Protocol summary

Summary
The aim of this study was to determine the effect of education based on the theory of planned behavior on childbirth fear rate. ( Inclusion criteria:The absence of mental diseases , high-risk pregnancy, pregnant women with no history of previous cesarean section, pregnant women at 28-36 weeks of pregnancy, pregnant women with fear score 28 or higher. Exclusion criteria: absence of women in ongoing training sessions (absence in more than one session of educational intervention sessions) , unwillingness to continue to participate in the study, the women's who did not access to post-test questionnaire. In the beginning, from four health care centers in four different areas of The Aleshtar city, intervention group and the control group of 50 people for each of the groups shall be elected randomly. In the intervention group educational content based on the theory of planned behavior, including knowledge, attitudes, subjective norms, perceived behavioral control and behavioral intention, to reduce fear of childbirth, as well as training by lecture and group discussion, and both the manual and the training pamphlet offered and at the end of three months after spacing, The questionnaire will be filled by pregnant women participating and training package will be given to the control group.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015120625399N1
Registration date: 2016-06-05, 1395/03/16
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-06-05, 1395/03/16
Registrant information
Name
Monir Yosefvand
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3368 6443
Email address
m.yosefvand@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-01-21, 1394/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of health education based on theory of planned behavior on fear of natural childbirth in pregnant women
Public title
The impact of education through lectures, question and answer on the fear of natural childbirth in pregnant women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:The absence of mental diseases , high-risk pregnancy, pregnant women with no history of previous cesarean section, pregnant women at 28-36 weeks of pregnancy, pregnant women with fear score 28 or higher. Exclusion criteria: absence of women in ongoing training sessions (absence in more than one session of educational intervention sessions) , unwillingness to continue to participate in the study, the women's who did not access to post-test questionnaire.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
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
Arak University of Medical Sciences
Street address
Arak University of Medical Sciences, Basij Sq., Sardashat, Arak
City
Arak
Postal code
00983818146851
Approval date
2015-07-05, 1394/04/14
Ethics committee reference number
IR.ARAKMU.REC.1394.166

Health conditions studied

empty

Primary outcomes

1

Description
Reducing fear of childbirth
Timepoint
Before and after the intervention
Method of measurement
Questionnaire

Secondary outcomes

1

Description
Knowledge, attitudes, subjective norms, perceived behavioral control and behavioral intention
Timepoint
Before and after the intervention
Method of measurement
Questionnaire

Intervention groups

1

Description
" Intervention group : According to the need assessment done to provide educational materials And in-person with booklets and pamphlets to pregnant women by the researcher and through lectures, question and answer and discussion ."
Category
Prevention

2

Description
"Control group: After the intervention, a brief leaflet samples from a control group provided educational materials to pregnant women."
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Lorestan University of Medical Sciences
Full name of responsible person
MonirYosefvand
Street address
Kamalvand, Khoramabad
City
Aleshtar

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences , Vice chancellor for research
Full name of responsible person
Mohammed Rafeie
Street address
Department of Education and Research, training Integrated Campus, Mobilization
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences , Vice chancellor for research
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
Arak University of Medical Sciences
Full name of responsible person
Monir Yosefvand
Position
Masters student
Other areas of specialty/work
Street address
School of Public Health, Golestan Alley, Mostafa Khomeini
City
Arak
Postal code
Phone
+98 66 3252 6519
Fax
Email
m.yosefvand@arakmu.ac.ir; yosefvand.20@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Doctor M. khorsandi
Position
PhD / Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Golestan Alley, Town Mostafa Khomeini, Arak
City
Arak
Postal code
00983818146851
Phone
+98 86 3368 6443
Fax
Email
dr.khorsandi@arakmu.ac.ir؛ khorsandi.mahboobeh@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Monir Yosefvand
Position
Masters student
Other areas of specialty/work
Street address
School of Public Health, Building No. 2, Golestan Alley, Town Mostafa Khomeini
City
Arak
Postal code
Phone
00
Fax
Email
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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