PregnancyPhase 2/3NCT01936610
the Effect of Instructional Method on Decision Making
A Phase 2/3 study testing role play and lecture in people with Pregnancy, run by Mashhad University of Medical Sciences.
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. Read more about this study
- Who is it for?
- Ages 20 to 28 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- role play and lecture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- No sites listed yet
- Study dates
- Jun 2010to Jul 2011
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 28 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- medical condition in pregnant woman, diagnosis of abnormal fetus / no possibility for delivery fetus by sonography, abnormal volume of amniotic fluid or placenta
About this study
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.
- Conditions
- Pregnancy
- Being tested
- role play, lecture
- Keywords
- Lecture, Role-playing, Knowledge, Attitude, Decision making, Type of delivery
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
role playOther
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.
lectureOther
Describe advantages and disadvantages in one 90-min session
| Study group | Role | What they receive |
|---|---|---|
| role play | Experimental | 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 . Receives: Other: role play |
| lecture | Experimental | describe the advantages and disadvantages of normal delivery and cesarian section Receives: Other: lecture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2013 (estimated)
- Study startJun 2010
- Primary completionJun 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mashhad University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zahra Abedian, Mashhad University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01936610
- Sponsor's protocol ID
- educational
- Status last verified
- May 2010
- First submitted
- 3 Sep 2013
- Last updated
- 6 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Effect of Instructional Method on Decision Making
- ClinicalTrials.gov ID
- NCT01936610
- Acronym / sponsor ID
- educational
- Conditions
- Pregnancy
- Keywords
- Lecture, Role-playing, Knowledge, Attitude, Decision making, Type of delivery
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Mashhad University of Medical SciencesUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 6 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| role play | Experimental | Other: role playIn 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 | Experimental | Other: lecturedescribe the advantages and disadvantages of normal delivery and cesarian section |
Who may qualify
- Ages
- 20 to 28 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- medical condition in pregnant woman, diagnosis of abnormal fetus / no possibility for delivery fetus by sonography, abnormal volume of amniotic fluid or placenta
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| role playIn 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. | Other | role play |
| lectureDescribe advantages and disadvantages in one 90-min session | Other | lecture |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing role play and lecture in people with Pregnancy, run by Mashhad University of Medical Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decision making (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2013.