Clinical trial of Comparing the effect of two teaching methods role playing and lecture on primigravida women’s knowledge, attitude and decision making in relation to type of delivery
This study is a randomized clinical trial performed with the aim of Comparing the effect of two teaching methods role playing and lecture on primi gravida women’s knowledge, attitude and decision making in relation to type of delivery. The study population included pregnant women referred to three health centers of Mashhad city . Sixty-seven pregnant women eligible for the study are selected by multistage sampling and distributed in two teaching role playing and lecture groups. Role- playing was performed by three scenarios, in seven stages and within 90 minutes. The same subjects presented during the 90 minutes in lecture group. Knowledge and attitude (before and two weeks after the intervention) and decision-making (before, two weeks after admission and in the delivery section) were evaluated by using a valid and reliable researcher-made questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015092623370N2
Registration date:2016-02-03, 1394/11/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-02-03, 1394/11/14
Registrant information
Name
Maryam Navaee
Name of organization / entity
Nursing and Midwifery Faculty
Country
Iran (Islamic Republic of)
Phone
+98 54 3344 4510
Email address
navaee.m@zamuc.ac.ir
Recruitment status
Recruitment complete
Funding source
University of Medical Sciences Mashhad, Vice chancellor for research
Expected recruitment start date
2010-07-23, 1389/05/01
Expected recruitment end date
2010-12-01, 1389/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of Comparing the effect of two teaching methods role playing and lecture on primigravida women’s knowledge, attitude and decision making in relation to type of delivery
Public title
effect of teaching methods role playing on pregnant women’s knowledge, attitude and decision making in relation to type of delivery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Normal pregnancy between 34-36 weeks; Ages 18 to 35; Cephalic presentation; Normal fetus and amniotic fluid volume; Singleton pregnancy; Maternal body mass index in the normal range (29 >BMI >19/8); At least a fifth-grade of elementry education; No history of infertility and acute or chronic cardiovascular diseases and systemic disease; Do not receive education prior to entering the study; Do not have indication for emergency cesarean;
Exclusion criteria:Disagree with stay in study; Delivery between 34 and 36 weeks of pregnancy; Reciving training from other sources such as TV.
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
67
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 at Mashhad University of Medical sciences
Street address
University of Medical Sciences , Daneshgah Street, Mashhad,Iran
City
Mashhad
Postal code
Approval date
2010-06-12, 1389/03/22
Ethics committee reference number
ir.mums.rec.1388.822
Health conditions studied
1
Description of health condition studied
Knowledge and attitude and decision-making
ICD-10 code
z55.9
ICD-10 code description
Problem related to education and literacy, unspecified
Primary outcomes
1
Description
knowledge of pregnant women in relation to type of delivery
Timepoint
before and two weeks after the intervention
Method of measurement
using a researcher-made questionnaire to investigate knowledge of pregnant women in relation to type of delivery
2
Description
attitude of pregnant women in relation to type of delivery
Timepoint
before and two weeks after the intervention
Method of measurement
using a researcher-made questionnaire to investigate attitude of pregnant women in relation to type of delivery
3
Description
decision-making of pregnant women in relation to type of delivery
Timepoint
before, two weeks after admission and in the delivery section
Method of measurement
using a researcher-made check list to investigate of decision-making of pregnant women in relation to type of delivery before, two weeks after admission and in the delivery section
Secondary outcomes
1
Description
Fear of childbirth
Timepoint
Before and two weeks after the intervention
Method of measurement
Using a harmen childbirth attitude questionnaire
2
Description
Stress, anxiety and depression
Timepoint
before and two weeks after the intervention
Method of measurement
Using a DASS-21 questionnaire
Intervention groups
1
Description
On intervention, the pregnant women’s knowledge, attitude and decision making in relation to type of delivery evaluated by using a valid and reliable researcher-made questionnaire. Then Role- playing was performed by three scenarios, in seven stages and within 90 minutes. Two weeks after the training, knowledge, attitude and decision making in relation to type of delivery completed Again by pregnant women and then following the groups to evaluated of final decision, continued until the labor and their decision to choose natural delivery or cesarean delivery after admission was recorded by telephone conversation. finally, The researchers refer to the hospital records of participants, recorded their type of delivery
Category
Prevention
2
Description
In lecture group, the pregnant women’s knowledge, attitude and decision making in relation to type of delivery evaluated by using a valid and reliable researcher-made questionnaire. Then, was learning about the advantage and disadvantages of vaginal delivery and cesarean section by whiteboard and markers in 90 minutes. Two weeks after the training, knowledge, attitude and decision making in relation to type of delivery completed Again by pregnant women and then following the groups to evaluated of final decision, continued until the labor and their decision to choose natural delivery or cesarean delivery after admission was recorded by telephone conversation. finally, The researchers refer to the hospital records of participants, recorded their type of delivery
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Health Center
Full name of responsible person
Fatemeh Jahani
Street address
Resalat Street, Mashhad, Iran
City
Mashhad
2
Recruitment center
Name of recruitment center
Shahid Motahari Health Center
Full name of responsible person
Samira Dashtizadeh
Street address
Motahari Street, Mashhad, Iran
City
Mashhad
3
Recruitment center
Name of recruitment center
Siloo Health Center
Full name of responsible person
Sohaila Arab
Street address
Resalat Street, Mashhad, Iran
City
Mashhad
4
Recruitment center
Name of recruitment center
Khaje Rabiee Health Center
Full name of responsible person
Zahra Saari
Street address
Kalat Street, Mashhad, Iran
City
Mashhad
5
Recruitment center
Name of recruitment center
Ahmadi Health Center
Full name of responsible person
Maasumeh Kordi
Street address
Qarani Street, Mashhad, Street
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Medical Sciences Mashhad, Vice chancellor for research
Full name of responsible person
Dr.Mohsen Tafaghodi
Street address
Mashhad University of Medical Sciences, Daneshgah Street, Mashhad,Iran
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Medical Sciences Mashhad, 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
Faculty Of Nursing And Midwifery
Full name of responsible person
Maryam Navaee
Position
Master degree, Coach
Other areas of specialty/work
Street address
Behdasht Street, Zahedan, Iran
City
Zahedan
Postal code
Phone
+98 54 3344 4510
Fax
Email
helennavaee@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty Of Nursing And Midwifery
Full name of responsible person
Maryam Navaee
Position
Master degree
Other areas of specialty/work
Street address
Behdasht street, Zahedan, Iran
City
Zahedan
Postal code
Phone
+98 54 3344 4510
Fax
Email
helennavaee@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty Of Nursing And Midwifery
Full name of responsible person
Maryam Navaee
Position
Msc
Other areas of specialty/work
Street address
Behdasht street, Zahedan, Iran
City
Zahedan
Postal code
Phone
+98 54 3344 4510
Fax
Email
helennavaee@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)