The aim of this study was to determine The effect of education based on the theory of planned behavior on the choice of painless delivery in primiparous women.
Design
Two arm parallel group randomised trial٬ not blinded, sample size of 90 people.
Settings and conduct
the statistical population consisted 90 pregnant women referred to Taleghani hospital in Arak who are selected by convenience sampling. After completing the questionnaire of fear of delivery and obtaining a score of more than 28, the samples are included in the study and the questionnaire, which in based on the theory of planned behavior, is completed by samples .Then, with a pot sampling 45 people are selected for each group.
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 choice of painless delivery, as well as face to face training, and both the training pamphlet and educational DVD/CD offered and at the end two months after intervention, the questionnaire will be filled by pregnant women participating and training package will be given to the control group.
Participants/Inclusion and exclusion criteria
inclusion criteria: pregnant women with child birth fear score 28 or higher, pregnant women at 28-36 weeks of pregnancy, prim gravid singleton women. exclusion criteria: unwillingness to continue to participate in the study
Intervention groups
1-(Intervention group) Presenting four sessions of 90 minutes in-person training in accordance with the educational needs of the pregnant women by pamphlet and educational CD by the researcher.
2-(control group)During the study, they receive routine pregnancy training.
Main outcome variables
Percentage of people who choose painless delivery with epidural analgesia.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180721040544N1
Registration date:2018-09-18, 1397/06/27
Registration timing:registered_while_recruiting
Last update:2018-09-18, 1397/06/27
Update count:0
Registration date
2018-09-18, 1397/06/27
Registrant information
Name
Fatemeh Khosravi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 4446 2166
Email address
f.khosravi95@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2018-10-22, 1397/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of education based on the theory of planned behavior on the choice of painless delivery with epidural analgesia in primiparous women.
Public title
The effect of education on the choice of painless delivery in primiparous women.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
inclusion criteria: pregnant women with child birth fear score 28 or higher
pregnant women at 28-36 weeks of pregnancy.
prim gravid singleton women.
Exclusion criteria:
unwillingness to participate in the study.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, a pot sampling method will be used. In this way, 45 papers are labeled "intervention" and 45 other words are written as "non-intervention". The paper is then placed in a sealed envelope, and individuals randomly select a paper and will be placed in the test or control group. The randomization unit will be in this method individually.
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 Arak University of Medical Sciences
Street address
Arak University of Medical Sciences, Basij Sq., Sardashat, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2018-04-29, 1397/02/09
Ethics committee reference number
IR.ARAKMU.REC.1397.018
Health conditions studied
1
Description of health condition studied
Single spontaneous delivery
ICD-10 code
O80
ICD-10 code description
Single spontaneous delivery
Primary outcomes
1
Description
Percentage of people who choose painless delivery with epidural analgesia.
Timepoint
Before and after the intervention
Method of measurement
The questionnaire is based on the theory of planned behavior.
Secondary outcomes
1
Description
Knowledge
Timepoint
Before and after the intervention
Method of measurement
The questionnaire is based on the theory of planned behavior.
2
Description
Attitudes
Timepoint
Before and after the intervention
Method of measurement
The questionnaire is based on the theory of planned behavior.
3
Description
Subjective norms
Timepoint
Before and after the intervention
Method of measurement
The questionnaire is based on the theory of planned behavior.
4
Description
perceived behavioral control
Timepoint
Before and after the intervention
Method of measurement
The questionnaire is based on the theory of planned behavior.
5
Description
behavioral intention
Timepoint
Before and after the intervention
Method of measurement
The questionnaire is based on the theory of planned behavior.
Intervention groups
1
Description
Presenting four sessions of 90 minutes in-person training in accordance with the educational needs of the pregnant women by pamphlet and educational CD by the researcher.
Category
Other
2
Description
Control group: During the study, they receive routine pregnancy training.