- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01936610
the Effect of Instructional Method on Decision Making
September 5, 2013 updated by: Zahra Abedian, Mashhad University of Medical Sciences
In these single- blind clinical trial 67 primigravida females, gestational aged 34-36 week were selected using multi-stage sampling and assigned into two groups randomly.
Decision-making (before, two weeks after and at admission in maternity department) was tested by a researcher -made questionnaire.
In experiment group, advantages and disadvantages of normal delivery and cesarean-section delivery were presented by role-playing in three 90-min scenarios.
It was also presented in a 90-min lecture.
Data were analyzed using SPSS by mean difference test, exact fisher test, independent t-test and paired t-test.
Study Overview
Study Type
Interventional
Enrollment (Actual)
67
Phase
- Phase 2
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 28 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
primipara , single pregnancy , gestational age of 34-36 weeks ,age of 18-35 years old, no history of infertility, no indication for cesarean section, no passing educational course for delivery methods
Exclusion Criteria:
medical condition in pregnant woman, diagnosis of abnormal fetus / no possibility for delivery fetus by sonography, abnormal volume of amniotic fluid or placenta
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: role play
In this method, researcher with two other co-researchers played 3 scenarios in 7 steps (for each scenario)including warm up, selecting participant, preparing the scene, preparing observers, play ,discussion and evaluation and generalization to education about advantages and disadvantages of normal delivery and cesarean section .
|
In this method, researcher with two other co-researchers played 3 scenarios in 7 steps (for each scenario)including warm up, selecting participant, preparing the scene, preparing observers, play ,discussion and evaluation and generalization to education about advantages and disadvantages of normal delivery and cesarean section.
|
|
EXPERIMENTAL: lecture
describe the advantages and disadvantages of normal delivery and cesarian section
|
Describe advantages and disadvantages in one 90-min session
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Decision making
Time Frame: 2 weeks
|
Two weeks after educational course for each group (Lecture and Role play), knowledge, attitude and decision making questionnaire were completed again.
They were followed at admission by phone conversation for knowing their decision.
|
2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2010
Primary Completion (ACTUAL)
June 1, 2011
Study Completion (ACTUAL)
July 1, 2011
Study Registration Dates
First Submitted
September 3, 2013
First Submitted That Met QC Criteria
September 5, 2013
First Posted (ESTIMATE)
September 6, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
September 6, 2013
Last Update Submitted That Met QC Criteria
September 5, 2013
Last Verified
May 1, 2010
More Information
Terms related to this study
Other Study ID Numbers
- educational
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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