PregnancyNCT02082964
The Effect of SCIM on Neonatal Resuscitation
A study testing SCIM and video in people with Pregnancy, run by Mashhad University of Medical Sciences at 1 site in Iran.
Trial summary
In this randomized controlled trial 48 students were randomly allocated in three groups SCIM, Video training (VT) and control group(no training). They had a workshops based on NRP and lasted 6 hours for each group. Before and after the workshops and one month later all students participated in a 7 station OSCE.. Read more about this study
- Who is it for?
- Ages 22 to 32 yearsHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- SCIM and video
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteIran
- Study dates
- Dec 2011to Mar 2012
- Phase
- Interventional
- 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 22 to 32 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy, without any history of severe stress in the past 6 months prior to the study. Accepts Healthy Volunteers
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
In this randomized controlled trial 48 students were randomly allocated in three groups SCIM, Video training (VT) and control group(no training). They had a workshops based on NRP and lasted 6 hours for each group. Before and after the workshops and one month later all students participated in a 7 station OSCE..
- Conditions
- Pregnancy
- Being tested
- SCIM, video
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCIMOther
after lecture students had rotation in 6 groups through 6 stations, trained and practiced under supervision of 6 instructors about Initial Steps, Positive Pressure Ventilation(PPV), Intubation, Chest Compressions, Medications and management of advanced resuscitation
videoOther
video about neonatal resuscitation presented then students repeated the video. Workshops was based on NRP and lasted 6 hours for each group the contentof the video was based on the educational content of the course
| Study group | Role | What they receive |
|---|---|---|
| SCIM | Experimental | after lecture students had rotation in 6 groups through 6 stations, trained and practiced under supervision of 6 instructors about Initial Steps, Positive Pressure Ventilation(PPV), Intubation, Chest Compressions, Medications and management of advanced resuscitation Receives: Other: SCIM |
| video | Experimental | video about neonatal resuscitation presented then students repeated the video. Workshops was based on NRP and lasted 6 hours for each group the contentof the video was based on the educational content of the course. Receives: Other: video |
What is being measured
The primary outcome is the main question the study is designed to answer.
education
after educational course for each group (SCIM and Video), students' competency in neonatal resuscitation would be evaluated through an OSCE in each group. the competency between group (before and after education) and in each group would be comapared before and after education.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2014 (estimated)
- Study startDec 2011
- Primary completionMar 2012
- Study completionMar 2012
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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mashhad University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, fatemeh erfanian, Mashhad University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02082964
- Sponsor's protocol ID
- training
- Status last verified
- Mar 2014
- First submitted
- 13 Feb 2014
- Last updated
- 11 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of SCIM on Neonatal Resuscitation
- ClinicalTrials.gov ID
- NCT02082964
- Acronym / sponsor ID
- training
- Conditions
- Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Mashhad University of Medical SciencesUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 11 Mar 2014 (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 this randomized controlled trial 48 students were randomly allocated in three groups SCIM, Video training (VT) and control group(no training). They had a workshops based on NRP and lasted 6 hours for each group. Before and after the workshops and one month later all students participated in a 7 station OSCE..
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCIM | Experimental | Other: SCIMafter lecture students had rotation in 6 groups through 6 stations, trained and practiced under supervision of 6 instructors about Initial Steps, Positive Pressure Ventilation(PPV), Intubation, Chest Compressions, Medications and management of advanced resuscitation |
| video | Experimental | Other: videovideo about neonatal resuscitation presented then students repeated the video. Workshops was based on NRP and lasted 6 hours for each group the contentof the video was based on the educational content of the course. |
Who may qualify
- Ages
- 22 to 32 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy, without any history of severe stress in the past 6 months prior to the study. Accepts Healthy Volunteers
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| SCIMafter lecture students had rotation in 6 groups through 6 stations, trained and practiced under supervision of 6 instructors about Initial Steps, Positive Pressure Ventilation(PPV), Intubation, Chest Compressions, Medications and management of advanced resuscitation | Other | SCIM |
| videovideo about neonatal resuscitation presented then students repeated the video. Workshops was based on NRP and lasted 6 hours for each group the contentof the video was based on the educational content of the course | Other | video |
Primary outcome
education
Time frame: 3 months
after educational course for each group (SCIM and Video), students' competency in neonatal resuscitation would be evaluated through an OSCE in each group. the competency between group (before and after education) and in each group would be comapared before and after education.
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 11 Mar 2014.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SCIM and video in people with Pregnancy, run by Mashhad University of Medical Sciences at 1 site in Iran.
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 11 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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?
education (time frame: 3 months). 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 11 Mar 2014.