the Effect of Instructional Method on Decision Making

Pregnancy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01936610
• Other study ID #: educational
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 3, 2013
• Last updated: September 5, 2013
• Start date: June 2010
• Est. completion date: July 2011

Study information

• Verified date: May 2010
• Source: Mashhad University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: July 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 28 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Pregnancy

Intervention

Other:
• 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.
• lecture
Describe advantages and disadvantages in one 90-min session

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mashhad University of Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decision making	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	No